U.S. patent application number 13/925129 was filed with the patent office on 2014-01-02 for electrical stimulation method for reduction of joint compression.
This patent application is currently assigned to ACCELERATED CARE PLUS CORP.. The applicant listed for this patent is J. CHRIS CASTEL, FRANCIS X. PALERMO. Invention is credited to J. CHRIS CASTEL, FRANCIS X. PALERMO.
Application Number | 20140005745 13/925129 |
Document ID | / |
Family ID | 41432011 |
Filed Date | 2014-01-02 |
United States Patent
Application |
20140005745 |
Kind Code |
A1 |
CASTEL; J. CHRIS ; et
al. |
January 2, 2014 |
ELECTRICAL STIMULATION METHOD FOR REDUCTION OF JOINT
COMPRESSION
Abstract
An electrical stimulation method for the reduction of joint
compression is disclosed. In a preferred embodiment, the method
utilizes an electrical stimulation device that includes a plurality
of channels of electrodes each of which includes at least a first
and second electrode positioned in electrical contact with tissue
of at least two muscles crossing a joint. Agonist/antagonist
muscles involved in abduction/adduction, flexion/extension,
supination/pronation, protraction/retraction, and/or
eversion/inversion of body regions via joint movement are
stimulated with a patterned series of electrical pulses through
channels of electrodes in accordance with a procedure for reducing
joint compression. The patterned series of electrical pulses may
comprise: a plurality of cycles of a biphasic sequential pulse
train pattern; a plurality of cycles of a biphasic overlapping
pulse train pattern; a plurality of cycles of a triphasic
sequential pulse train pattern; and a plurality of cycles of a
triphasic overlapping pulse train pattern.
Inventors: |
CASTEL; J. CHRIS; (Reno,
NV) ; PALERMO; FRANCIS X.; (Boulder, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CASTEL; J. CHRIS
PALERMO; FRANCIS X. |
Reno
Boulder |
NV
CO |
US
US |
|
|
Assignee: |
ACCELERATED CARE PLUS CORP.
Reno
NV
|
Family ID: |
41432011 |
Appl. No.: |
13/925129 |
Filed: |
June 24, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12487431 |
Jun 18, 2009 |
8473064 |
|
|
13925129 |
|
|
|
|
61073653 |
Jun 18, 2008 |
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Current U.S.
Class: |
607/48 |
Current CPC
Class: |
A61N 1/36003 20130101;
A61N 1/36031 20170801; A61N 1/36034 20170801; A61N 1/0452
20130101 |
Class at
Publication: |
607/48 |
International
Class: |
A61N 1/04 20060101
A61N001/04 |
Claims
1. A method for reducing joint compression caused by co-contraction
of antagonist and agonist muscles in a patient in need thereof,
comprising: applying neuromuscular electrical stimulation having a
biphasic or triphasic pulse train pattern to at least two muscles
associated with a target joint in said patient; and wherein said
step of applying neuromuscular stimulation decreases co-contraction
of said at least two muscles after said applying step.
2. The method of claim 1, wherein said step of applying
neuromuscular electrical stimulation having a biphasic or triphasic
pulse train pattern comprises: providing a first channel comprising
two electrodes, wherein a first electrode of said first channel is
positioned in electrical contact with tissue of a first muscle of
said target joint of said patient and a second electrode of said
first channel is positioned in electrical contact with tissue of
said first muscle or a second muscle of said target joint of said
patient; providing a second channel comprising two electrodes,
wherein a first electrode of said second channel is positioned in
electrical contact with tissue of said second muscle or a third
muscle of said target joint of said patient and a second electrode
of said second channel is positioned in electrical contact with
tissue of said second muscle, third muscle or a fourth muscle of
said target joint of said patient; and applying a series of
electrical pulses having said biphasic or triphasic pulse train
pattern to said target joint of said patient through said first and
second channels in accordance with said procedure for reducing said
joint compression.
3. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a trapezius muscle
of said patient, and said second electrode of said first channel is
positioned so as to stimulate a cervical paraspinal muscle of said
patient; and wherein said first and second electrodes of said
second channel are positioned bilaterally so as to stimulate a
second trapezius muscle and a second cervical paraspinal muscle of
said patient.
4. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a lower cervical
paraspinal muscle and an upper thoracic paraspinal muscle of said
patient, and said second electrode of said first channel is
positioned so as to stimulate a cervical paraspinal muscle of said
patient; and wherein said first and second electrodes of said
second channel are positioned bilaterally so as to stimulate a
second lower cervical paraspinal muscle, a second upper thoracic
paraspinal muscle, and a second cervical paraspinal muscle of said
patient.
5. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a thoracic
paraspinal muscle of said patient, and said second electrode of
said first channel is positioned so as to stimulate an upper
thoracic paraspinal muscle of said patient; and wherein said first
and second electrodes of said second channel are positioned
bilaterally so as to stimulate a second thoracic paraspinal muscle
and a second upper thoracic paraspinal muscle of said patient.
6. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a thoracic and/or
lumbar paraspinal muscle of said patient, and said second electrode
of said first channel is positioned so as to stimulate an abdominal
muscle of said patient; and wherein said first and second
electrodes of said second channel are positioned bilaterally so as
to stimulate a second thoracic and/or lumbar paraspinal muscle and
a second abdominal muscle of said patient.
7. The method of claim 2, wherein said first and second channels
each further comprise a third electrode and a fourth electrode;
wherein said first and second electrodes of said first channel are
positioned so as to stimulate a multifidus muscle of said patient,
and said third and fourth electrodes of said first channel are
positioned so as to stimulate an abdominal muscle of said patient;
and wherein said first, second, third, and fourth electrodes of
said second channel are positioned bilaterally so as to stimulate a
second multifidus muscle and a second abdominal muscle of said
patient.
8. The method of claim 2, wherein said first and second electrodes
of said first channel are positioned so as to stimulate a biceps
brachii muscle of said patient; and wherein said first and second
electrodes of said second channel are positioned so as to stimulate
a triceps brachii muscle of said patient.
9. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a biceps brachii
muscle of said patient, and said second electrode of said first
channel is positioned so as to stimulate a pectoralis major muscle
and an anterior deltoid muscle of said patient; and wherein said
first electrode of said second channel is positioned so as to
stimulate a triceps brachii muscle of said patient, and said second
electrode of said second channel is positioned so as to stimulate
an infraspinatus teres minor muscle and a posterior deltoid muscle
of said patient.
10. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a biceps brachii
muscle of said patient, and said second electrode of said first
channel is positioned so as to stimulate an anterior deltoid muscle
of said patient; and wherein said first electrode of said second
channel is positioned so as to stimulate a triceps brachii muscle
of said patient, and said second electrode of said second channel
is positioned so as to stimulate a posterior deltoid muscle of said
patient.
11. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a flexor muscle of a
hand of said patient selected from a group consisting of flexor
digitorum superficialis and flexor digitorum profundus, and said
second electrode of said first channel is positioned so as to
stimulate a flexor muscle of a wrist of said patient selected from
the group consisting of flexor carpi ulnaris and flexor carpi
radialis; and wherein said first electrode of said second channel
is positioned so as to stimulate an extensor muscle of said hand of
said patient selected from the group consisting of extensor
digitorum and extensor digiti minimi, and said second electrode of
said second channel is positioned so as to stimulate an extensor
muscle of said wrist of said patient selected from the group
consisting of extensor carpi ulnaris and extensor carpi
radialis.
12. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a flexor muscle of a
hand of said patient, and said second electrode of said first
channel is positioned so as to stimulate a biceps brachii muscle of
said patient; and wherein said first electrode of said second
channel is positioned so as to stimulate an extensor forearm muscle
of said patient, and said second electrode of said second channel
is positioned so as to stimulate a triceps brachii muscle of said
patient.
13. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate an extensor
digitorum brevis muscle of said patient, and said second electrode
of said first channel is positioned so as to stimulate a tibialis
anterior muscle, an extensor digitorum longus muscle, and/or an
extensor hallucis longus muscle of said patient; and wherein said
first electrode of said second channel is positioned so as to
stimulate an intrinsic foot muscle of said patient, and said second
electrode of said second channel is positioned so as to stimulate a
posterior tibialis muscle and a flexor hallucis muscle of said
patient.
14. The method of claim 2, wherein said first and second electrodes
of said first channel are positioned so as to stimulate a tibialis
anterior muscle and an optional peroneus muscle of said patient;
and wherein said first and second electrodes of said second channel
are positioned so as to stimulate a triceps surae of said
patient.
15. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a tibialis anterior
muscle of said patient, and said second electrode of said first
channel is positioned so as to stimulate a quadriceps muscle of a
leg of said patient; and wherein said first electrode of said
second channel is positioned so as to stimulate a triceps surae of
said patient, and said second electrode of said second channel is
positioned so as to stimulate a hamstring muscle of said leg of
said patient.
16. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a vastus medialis
muscle of said patient, and said second electrode of said first
channel is positioned so as to stimulate a gluteus medius muscle, a
gluteus minimus muscle, and a tensor fasciae latae muscle of said
patient; and wherein said first electrode of said second channel is
positioned so as to stimulate a biceps femoris muscle, a
semitendinosus muscle, and/or a semimembraneous muscle of said
patient, and said second electrode of said second channel is
positioned so as to stimulate an adductor magnus muscle, an
adductor longus muscle, an adductor brevis muscle, and a medial
hamstring muscle of said patient.
17. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate a rectus femoris
muscle and/or a vastus lateralis muscle of said patient, and said
second electrode of said first channel is positioned so as to
stimulate a vastus medialis muscle of said patient; and wherein
said first and second electrodes of said second channel are
positioned so as to stimulate a biceps femoris muscle, a
semimembranosus muscle, and/or a semitendinosus muscle of said leg
of said patient.
18. The method of claim 1, wherein said decreased co-contraction is
determined using EMG.
19. The method of claim 1, wherein said decreased co-contraction is
determined using a tissue hardness and tissue compliance measuring
system.
20. The method of claim 1, further comprising a step of
co-administering said electrical stimulation to said patient and a
therapeutically effective amount of an agent selected from a group
consisting of nonsteroidal anti-inflammatory drugs (NSAIDS) or
analgesics; tramadol; codeine; propoxyphene; glucosamine;
chondroitin sulfate; salicylates; Cox-2 NSAIDS; surface application
of capsaicin cream 0.25%; steroids, corticosteroids, or hyaluronic
acid preparations.
21. The method of claim 2, wherein said series of electrical pulses
comprises a plurality of cycles of a biphasic sequential pulse
train pattern; and wherein said biphasic sequential pulse train
pattern comprises a first phase of electrical pulses applied to
said first channel and a second phase of electrical pulses applied
to said second channel, and wherein said second phase of electrical
pulses commences after termination of said first phase of
electrical pulses.
22. The method of claim 2, wherein said series of electrical pulses
comprises a plurality of cycles of a biphasic overlapping pulse
train pattern; and wherein said biphasic overlapping pulse train
pattern comprises a first phase of electrical pulses applied to
said first channel and a second phase of electrical pulses applied
to said second channel, and wherein said second phase of electrical
pulses commences before termination of said first phase of
electrical pulses.
23. The method of claim 2, wherein said series of electrical pulses
comprises a plurality of cycles of a triphasic sequential pulse
train pattern; wherein said triphasic sequential pulse train
pattern comprises a first phase of electrical pulses applied to
said first channel, a second phase of electrical pulses applied to
said second channel, and a third phase of electrical pulses applied
to said first channel; and wherein said second phase of electrical
pulses commences after termination of said first phase of
electrical pulses and said third phase of electrical pulses
commences after termination of said second phase of electrical
pulses.
24. The method of claim 2, wherein said series of electrical pulses
comprises a plurality of cycles of a triphasic overlapping pulse
train pattern; wherein said triphasic overlapping pulse train
pattern comprises a first phase of electrical pulses applied to
said first channel, a second phase of electrical pulses applied to
said second channel, and a third phase of electrical pulses applied
to said first channel; and wherein said second phase of electrical
pulses commences before termination of said first phase of
electrical pulses and said third phase of electrical pulses
commences before termination of said second phase of electrical
pulses.
25. The method of claim 1, wherein a delay between each said pulse
train pattern is between 400 milliseconds and 1200
milliseconds.
26. The method of claim 1 wherein said decreased co-contraction is
measured by a decrease in the I-EMG in said at least two target
muscles of said patient at rest or at a predetermined load.
27. The method of claim 1 wherein said decreased co-contraction is
measured by a decrease in the FFT in said at least two target
muscles of said patient at rest or at a predetermined load.
28. The method of claim 1 wherein said decreased co-contraction is
measured by a decrease in the hardness of said at least two target
muscles using a tissue hardness and tissue compliance measurement
system.
29. The method of claim 2, wherein said first electrode of said
first channel is positioned so as to stimulate an upper quadricep
muscle of said patient, and said second electrode of said first
channel is positioned so as to stimulate a vastus medialis muscle
of said patient; and wherein said first electrode of said second
channel is positioned so as to stimulate a hamstring muscle of said
patient, and said second electrode of said second channel is
positioned so as to stimulate a triceps surae muscle of said
patient.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and is a continuation of
U.S. patent application Ser. No. 12/487,431, filed on Jun. 18,
2009, which claims the benefit of U.S. Provisional Patent
Application Ser. No. 61/073,653, filed on Jun. 18, 2008, each of
which is incorporated herein by reference in its entirety.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not applicable.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0003] Not applicable.
FIELD OF THE INVENTION
[0004] The present invention is generally directed to a method for
reducing joint compression, and is more specifically directed to an
electrical stimulation method for applying a patterned series of
electrical pulses to a plurality of channels of electrodes in
accordance with a procedure for reducing joint compression. The
method results in improved muscle and nerve timing, which reduces
co-activation of muscles associated with joints during movement or
during stabilization.
DESCRIPTION OF RELATED ART
[0005] The junction of two or more bones or skeletal parts is a
joint. There are several types of human joints including fibrous
(non-movable), cartilaginous (connected entirely by cartilage), and
synovial joints. A synovial joint is a freely movable articulation,
in which contiguous bone surfaces are covered with collagenous
fibrovascular tissue composed of flattened or cuboidal cells. The
collagenous fibrovascular tissue is called articular cartilage.
Examples of human synovial joints include the elbow, shoulder,
wrist, ankle, knee, hip, and intervertebral joints.
[0006] In a healthy human synovial joint, a synovial membrane
surrounds the articular cartilage and contains synovial fluid.
Synovial fluid is normally clear, resembling egg white. Synovial
fluid lubricates the joint by providing a thin liquid layer over
the articular cartilage. The synovial fluid also carries oxygen and
nutrients to the articular cartilage by diffusing into the spaces
in the articular cartilage during non-movement. During movement,
the synovial fluid is squeezed out of the articular cartilage to
maintain the surface liquid layer for lubrication and carry waste
away from the articular cartilage. When the joint is at rest again,
the synovial fluid diffuses back into the articular cartilage
carrying with it a supply of nutrients and oxygen that it obtained
from the increased blood flow around the joint during movement. The
health of the articular cartilage is dependent upon the extrusion
and diffusion of the synovial fluid normally caused by joint
movement.
[0007] A common form of joint pain and/or stiffness arises from the
unwanted co-contraction of muscles. The simultaneous contraction of
an antagonist muscle and its corresponding agonist muscle is termed
"co-contraction". The co-contraction causes joint compression,
which results in the degeneration or "wear and tear" of articular
cartilage and is usually accompanied by an overgrowth of bone,
narrowing of the joint space, sclerosis or hardening of bone at the
joint surface, and deformity in joints. Weight bearing joints, such
as the knees and hips, are particularly susceptible to
osteoarthritis.
[0008] Unwanted involuntary muscle co-contraction, as a response to
an abnormal stimulus such as pain during joint movement, can be
destructive to the joint over time. Sustained co-contraction
increases the local level of norepinephrine. Norepinephrine causes
vasoconstriction, which decreases blood flow. Decreased blood flow
prevents the synovial fluid from picking up oxygen and nutrients to
carry back to the articular cartilage. In addition to decreasing
blood flow, sustained co-contraction of opposing muscle groups has
a net effect of increasing the compressive force across the joint.
The constant increased compressive force squeezes the synovial
fluid out of the articular cartilage and prevents it from diffusing
back in thereby starving the articular cartilage of oxygen and
nutrients. The starved articular cartilage deteriorates, which
leads to additional pain, decreased coordination, increased joint
stiffness, and eventual total joint degeneration.
[0009] Carroll et al., U.S. Patent Application 2004/0054379 teaches
the use of surface electrical simulation for increasing the quality
and quantity of synovial fluid in joints. The patent emphasizes
that the electrical simulation is that which "mimics normal
electrical sequencing of surrounding muscles of the joint during
normal functioning activity." See Para 0016. Thus, Carroll utilizes
a functional sequence which causes the joint to move.
BRIEF SUMMARY OF THE INVENTION
[0010] The present invention is directed to an electrical
stimulation method for reducing joint compression in a patient by
decreasing the unwanted co-contraction of agonist/antagonist muscle
pairs associated with a joint. In general, the electrical
stimulation method utilizes an electronic control unit connected to
two or more channels of electrodes, such as transcutaneous or
percutaneous electrodes. Each channel comprises at least two
electrodes (i.e., at least one relative positive electrode and at
least one relative negative electrode), wherein one electrode is
positioned in electrical contact with a first tissue of a first
muscle of a target joint of a patient and the other electrode is
positioned in electrical contact with a second tissue of a second
muscle of a target joint of a patient. The electrical control unit
applies a series of electrical pulses having a biphasic or
triphasic pattern to the patient through the two or more channels
of electrodes in accordance with a procedure for reducing joint
compression in the patient.
[0011] In one aspect, the electrical stimulation method stimulates
the sensory and motor nerves of the patient's musculature
associated with opposing joint movement. For example, electrodes
can be positioned bilaterally or in electrical contact with the
tissue of agonist/antagonist muscle pairs in the neck, trunk,
shoulder, arm, wrist, hand, hip, thigh, lower leg, ankle, and foot
of the patient that are associated with a joint. Examples of
agonist/antagonist muscle pairs include abductors/adductors,
flexors/extensors, supinators/pronators, protractors/retractors,
and evertors/inverters. For example, both the flexor carpi radialis
and flexor carpi ulnaris are flexors of the wrist. The extensor
carpi radialis longus, in conjunction with extensor carpi radialis
brevis, is an extensor of the wrist.
[0012] In a first embodiment, the electrical stimulation method can
be used to stimulate the muscles associated with the cervical
intervertebral joints. For example, the electrodes are positioned
in electrical contact with tissue to stimulate a motor point of a
patient's trapezius muscle and cervical paraspinal muscles.
[0013] In a second embodiment, the electrical stimulation method
can be used to stimulate the muscles associated with the lower
cervical and upper thoracic intervertebral joints. For example, the
electrodes are positioned in electrical contact with tissue to
stimulate a motor point of a patient's trapezius muscle and
cervical and/or thoracic paraspinal muscles.
[0014] In a third embodiment, the electrical stimulation method can
be used to stimulate the muscles associated with the upper thoracic
intervertebral joints. For example, the electrodes are positioned
in electrical contact with tissue to stimulate a motor point of a
patient's trapezius muscle, erector spinae muscle, and thoracic
paraspinal muscles.
[0015] In a fourth embodiment, the electrical stimulation method
can be used to stimulate the muscles associated with the lower
thoracic and lumbar intervertebral joints. For example, the
electrodes are positioned in electrical contact with tissue to
stimulate a motor point of a patient's lower thoracic and lumbar
paraspinal muscles and abdominal muscles.
[0016] In a fifth embodiment, the electrical stimulation method can
be used to stimulate the muscles associated with the lower thoracic
and lumbar intervertebral joints. For example, the electrodes are
positioned in electrical contact with tissue to stimulate a motor
point of a patient's multifidus muscle and abdominal muscles.
[0017] In a sixth embodiment, the electrical stimulation method can
be used to stimulate the muscles associated with the elbow joint.
For example, the electrodes are positioned in electrical contact
with tissue to stimulate a motor point of a patient's biceps
brachii muscle and triceps brachii muscle.
[0018] In a seventh embodiment, the electrical stimulation method
can be used to stimulate the muscles associated with the shoulder
joint. For example, the electrodes are positioned in electrical
contact with tissue to stimulate a motor point of a patient's
biceps brachii, pectoralis major, anterior deltoid, triceps
brachii, infraspinatus teres minor, and posterior deltoid
muscles.
[0019] In an eighth embodiment, the electrical stimulation method
can be used to stimulate the muscles associated with the shoulder
and elbow joints. For example, the electrodes are positioned in
electrical contact with tissue to stimulate a motor point of a
patient's biceps brachii muscle, anterior deltoid muscle, triceps
brachii muscle, and posterior deltoid muscle.
[0020] In a ninth embodiment, the electrical stimulation method can
be used to stimulate the muscles associated with the wrist joint.
For example, the electrodes are positioned in electrical contact
with tissue to stimulate a motor point of a patient's flexor
digitorum superficialis muscle, flexor carpi radialis muscle,
flexor carpi ulnaris muscle, extensor digitorum muscle, pollicis
muscle, extensor digiti minimi muscle, extensor carpi ulnaris
muscle, extensor carpi radialis longus muscle, and/or carpi
radialis brevis muscle.
[0021] In a tenth embodiment, the electrical stimulation method can
be used to stimulate the muscles associated with the wrist and
elbow joints. For example, the electrodes are positioned in
electrical contact with tissue to stimulate a motor point of a
patient's biceps brachii muscle, triceps brachii muscle, intrinsic
hand muscles, and/or extensor muscles of the forearm.
[0022] In an eleventh embodiment, the electrical stimulation method
can be used to stimulate the muscles associated with the ankle
joint. For example, the electrodes are positioned in electrical
contact with tissue to stimulate a motor point of a patient's
extensor digitorum brevis muscle, tibialis anterior muscle,
extensor digitorum longus muscle, extensor hallucis longus muscle,
posterior tibialis muscle, flexor hallucis muscle, and/or intrinsic
foot muscles including abductor hallucis muscle.
[0023] In a twelfth embodiment, the electrical stimulation method
can be used to stimulate the muscles associated with the ankle
joint. For example, the electrodes are positioned in electrical
contact with tissue to stimulate a motor point of a patient's
tibialis anterior muscle, triceps surae muscle group including
gastrocnemius and soleus muscles, and/or anterior and lateral
muscles of the leg including the peroneus muscle.
[0024] In a thirteenth embodiment, the electrical stimulation
method can be used to stimulate the muscles associated with the
knee joint. For example, the electrodes are positioned in
electrical contact with tissue to stimulate a motor point of a
patient's tibialis anterior, quadriceps, triceps surae, and/or
hamstring muscles.
[0025] In a fourteenth embodiment, the electrical stimulation
method can be used to stimulate the muscles associated with the hip
and knee joints. For example, the electrodes are positioned in
electrical contact with tissue to stimulate a motor point of a
patient's quadriceps muscle group, vastus medialis muscle, gluteus
medius muscle, gluteus minimus muscle, gluteus maximus muscle,
tensor faciae latae muscle, hamstring muscle group including biceps
femoris muscle, semitendinosus muscle, and/or semimembraneous
muscle, adductor magnus muscle, adductor longus muscle, adductor
brevis muscle, and medial hamstring muscles.
[0026] In a fifteenth embodiment, the electrical stimulation method
can be used to stimulate the muscles associated with the knee
joint. For example, the electrodes are positioned in electrical
contact with tissue to stimulate a motor point of a patient's
rectus femoris muscle, vastus lateralis muscle, vastus medialis
muscle, biceps femoris muscle, semimembranosus muscle and/or
semitendinosus muscle.
[0027] In yet a sixteenth embodiment, the electrical stimulation
can be used to stimulate the muscles associated with the knee
joint. For example, the first pair of electrodes are generally
positioned on the patient's skin on the vastus medialis and upper
quadricep, and the second pair is positioned on the hamstring and
triceps surae muscles.
[0028] The series of electrical pulses applied to the one or more
channels of electrodes may comprise a variety of different types of
biphasic or triphasic pulse train patterns. For example, a
plurality of cycles of a biphasic sequential or overlapping pulse
train pattern may be used, in which a first phase of electrical
pulses is applied to a first channel of electrodes, and a second
phase of electrical pulses is applied to a second channel of
electrodes. Using the biphasic sequential pulse train pattern, the
second phase of electrical pulses commences after termination of
the first phase of electrical pulses such that there is a time
delay there between. Using the biphasic overlapping pulse train
pattern, the second phase of electrical pulses commences before
termination of the first phase of electrical pulses such that there
is an overlap there between.
[0029] In another example, a plurality of cycles of a triphasic
sequential or overlapping pulse train pattern may be used, in which
a first phase of electrical pulses is applied to a first channel of
electrodes, a second phase of electrical pulses is applied to a
second channel of electrodes, and a third phase of electrical
pulses is applied to the first channel of electrodes. Using the
triphasic sequential pulse train pattern, the second phase of
electrical pulses commences after termination of the first phase of
electrical pulses such that there is a time delay there between,
and, similarly, the third phase of electrical pulses commences
after termination of the second phase of electrical pulses such
that there is a time delay there between. Using the triphasic
overlapping pulse train pattern, the second phase of electrical
pulses commences before termination of the first phase of
electrical pulses such that there is an overlap there between, and,
similarly, the third phase of electrical pulses commences before
termination of the second phase of electrical pulses such that
there is an overlap there between.
[0030] In one aspect of the present invention, reduction of joint
compression is shown by decreased co-contraction in opposing muscle
groups associated with a joint as measured by muscle hardness
and/or electromyography ("EMG") patterns. EMG is a technique for
evaluating and recording the electrical activity of muscles at rest
and while contracting. An electromyograph is used to produce an
electromyogram, which is a graphic record of the electrical
potential generated by muscle cells at rest and during contraction
plotted over time. At rest, normal muscle tissue is electrically
inactive. During contraction, normal muscle tissue is electrically
active and produces action potentials that appear as peaks on the
electromyogram. The electrical activity of multiple muscles can be
tracked in relation to one another using EMG. When the EMG pattern
for multiple muscles (agonist and antagonist) are compared, the
length of time the action potential peaks overlap indicates the
length of muscle co-contraction. In a preferred aspect, the EMG is
integrated ("I-EMG") using commercially available hardware or
software. The raw EMG signal is preferably rectified and integrated
at a sample rate of 100-1000 Hz. The resulting data is then
displayed as a value plotted on a graph.
[0031] A signal's frequency can be calculated in several possible
ways, including via Fourier (and more easily implemented fast
Fourier transform ("FFT")) transforms, measuring signal amplitude
after band pass filtering, and via half waves. Thus, in another
aspect, the reduction of joint compression is shown by decreased
co-contraction in opposing muscle groups associated with a joint
(agonist and antagonist) as measured by muscle hardness and/or FFT
patterns. Higher mean frequencies and frequency spectrums indicates
that the muscle is firing harder.
[0032] In another aspect of the present invention, reduction in
joint compression is shown by decreased hypertonia measured using a
tissue hardness and compliance measurement device. Hypertonia is
abnormal increased muscle tone. Hypertonia of opposing muscles
across a joint during movement or non-movement indicates joint
compression. A tissue hardness and compliance measurement device
typically comprises a metal probe approximately 1 cm.sup.2 in area
surrounded by a metal or plastic sleeve approximately 5 cm in
diameter. Using a downward pressure, an examiner pushes the blunt
metal probe perpendicular to the surface of the skin overlying the
muscle to be tested. For example, compliance and tone of the right
quadriceps femoris muscle can be measured by placing the tissue
hardness and compliance measurement device above the right superior
border of the patella at the thigh center line while a patient is
seated. The probe does not penetrate the skin and only a light
pressure by the examiner is needed. The tissue hardness and
compliance measurement device measures the amount of deformation
that occurs within the muscle (millimeter deflection) to a given
unit of force. Muscle millimeter deflection can be measured when
the muscle is relaxed to obtain a base-line muscle tone and
compliance measurement. Muscle millimeter deflection can also be
measured when the muscle is at varying levels of contraction.
Varying levels of muscle contraction can be repeatedly obtained
using a dynamometer. The higher the tone within the muscle, the
less muscle millimeter deflection per unit of force. Muscle tone
increases with the level of muscle contraction.
[0033] The electrical stimulation methods for reducing joint
compression of the present invention are well-adapted to be used
with other conventional therapies for overall joint health,
including, but not limited to: implementing a supervised exercise
program involving low-impact activities such as walking, swimming,
and cycling; maintaining an ideal body weight; rest periods;
applications of heat and cold; applications of light or lasers,
application of pulsed and continuous magnetic fields, applications
of electrical stimulation for pain control, nonsteroidal
anti-inflammatory drugs (NSAIDS) or analgesics such as
acetaminophen, ibuprofen, naproxen, or aspirin; tramadol; codeine;
propoxyphene; glucosamine; chondroitin sulfate; salicylates; Cox-2
NSAIDS; surface application of capsaicin cream 0.25%;
intra-articular injections of steroids, corticosteroids, or
hyaluronic acid preparations; bracing, splinting, or orthotic
treatments; and surgery including joint replacement and
arthroscopic procedures.
[0034] Additional aspects of the invention, together with the
advantages and novel features appurtenant thereto, will be set
forth in part in the description which follows, and in part will
become apparent to those skilled in the art upon examination of the
following, or may be learned from the practice of the invention.
The objects and advantages of the invention may be realized and
attained by means of the instrumentalities and combinations
particularly pointed out in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] The present invention will be described in greater detail in
the following detailed description of the invention with reference
to the accompanying drawings that form a part hereof, in which:
[0036] FIG. 1 is a block diagram of an electrical stimulation
device that may be used in accordance with the method of the
present invention;
[0037] FIG. 2A is a timing diagram of a biphasic sequential pulse
train pattern that may be applied to the output channels of the
electrical stimulation device of FIG. 1;
[0038] FIG. 2B is a timing diagram of a biphasic overlapping pulse
train pattern that may be applied to the output channels of the
electrical stimulation device of FIG. 1;
[0039] FIG. 2C is a timing diagram of a triphasic sequential pulse
train pattern that may be applied to the output channels of the
electrical stimulation device of FIG. 1;
[0040] FIG. 2D is a timing diagram of a triphasic overlapping pulse
train pattern that may be applied to the output channels of the
electrical stimulation device of FIG. 1;
[0041] FIG. 3A illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a first exemplary embodiment of the present invention;
[0042] FIG. 3B illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a second exemplary embodiment of the present invention;
[0043] FIG. 3C illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a third exemplary embodiment of the present invention;
[0044] FIG. 3D illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a fourth exemplary embodiment of the present invention;
[0045] FIG. 3E illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a fifth exemplary embodiment of the present invention;
[0046] FIG. 3F illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a sixth exemplary embodiment of the present invention;
[0047] FIG. 3G illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a seventh exemplary embodiment of the present invention; and
[0048] FIG. 3H illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
an eighth exemplary embodiment of the present invention.
[0049] FIG. 3I illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a ninth exemplary embodiment of the present invention.
[0050] FIG. 3J illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a tenth exemplary embodiment of the present invention.
[0051] FIG. 3K illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
an eleventh exemplary embodiment of the present invention.
[0052] FIG. 3L illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a twelfth exemplary embodiment of the present invention.
[0053] FIG. 3M illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a thirteenth exemplary embodiment of the present invention.
[0054] FIG. 3N illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a fourteenth exemplary embodiment of the present invention.
[0055] FIG. 3O illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a fifteenth exemplary embodiment of the present invention.
[0056] FIG. 3P illustrates a method for treating joint compression
in a patient by applying electrical stimulation in accordance with
a sixteenth exemplary embodiment of the present invention.
[0057] FIG. 4 illustrates the correlation between muscle hardness
and the I-EMG ratio. The Spearman's correlation coefficient was
R=0.618, p<0.01, N=14. This demonstrates that the measurement of
muscle hardness is directly correlated to the I-EMG ratio between
the agonist and antagonist muscles.
[0058] FIG. 5 illustrates the relationship between muscle hardness
and the FFT ratio. The Spearman's correlation coefficient was
R=0.447, p<0.01, N=14. This demonstrates that the measurement of
muscle hardness is directly correlated to the FFT ratio between the
agonist and antagonist muscles.
[0059] FIG. 6 illustrates the relationship between the FTT ratio
and the I-EMG ratio. The Spearman's correlation coefficient was
R=0.466, p<0.01, N=14. This demonstrates that the FFT ratio is
directly correlated to the I-EMG ratio between the agonist and
antagonist muscles.
[0060] FIGS. 7A and 7B show the Visual Analog Scores of the five
patients who received patterned neuromuscular stimulation as
described in Example 2. FIG. 7A shows the patients' pain level,
while FIG. 7B illustrates the patients' reported overall
condition
[0061] FIG. 8 illustrates the results of the Western Ontario
MacMaster 3.1 (WOMAC) tests performed on the five patients from
Example 2.
[0062] FIGS. 9 and 10 show the muscle strength of each patient
throughout the course of treatment for the quadriceps, and
hamstrings respectively for the five patients in Example 2.
[0063] FIGS. 11A, 11B and 11C show the results of a "stand-up" test
performed by the patients from Example 2. In FIG. 11A, the
immediate effect of the patterned neuromuscular electrical
stimulation is shown by the patients; VAS pain level. FIG. 11B
illustrates the amount of time it took to complete the test for
each patient. In FIG. 11C, the amount of time it took to complete
the test was reported over the entire 24-week treatment course.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENT
[0064] The present invention is directed to an electrical
stimulation method for reducing joint compression.
[0065] As used herein, the term "administration" refers to a method
of giving an agent to a patient, where the method is, e.g.,
topical, oral, intravenous, transdermal, intraperitoneal, or
intramuscular. The preferred method of administration can vary
depending on various factors, e.g., the components of the
pharmaceutical composition.
[0066] As used herein, "concurrent administration,"
"co-administration," or "co-treatment" includes administration of
the agents or application of the electrical stimulation treatment
method together, or before or after each other. The therapeutic
agents co-administered with the electrical stimulation treatment
methods may be administered by the same or different routes.
[0067] The phrase "pharmaceutically acceptable" is employed herein
to refer to those compounds, materials, compositions, and/or dosage
forms which are, within the scope of sound medical judgment,
suitable for use in contact with the tissues of human beings and
animals without excessive toxicity, irritation, allergic response,
or other problem or complication, commensurate with a reasonable
benefit/risk ratio.
[0068] The phrase "therapeutically effective amount" as used
herein, means that amount of an active agent which, alone or in
combination with other drugs, provides a therapeutic benefit in the
prevention, treatment, or management of joint compression.
Different therapeutically effective amounts may be readily
determined by those of ordinary skill in the art.
[0069] As used herein, the term "electrical stimulation" refers to
the passing of various types of current to a patient through
transcutaneous or percutaneous electrodes, and includes muscle
activation by stimulation of the nerves innervating the sensory
(cutaneous and position sensors) and muscle fibers associated with
central pattern generator inputs or inhibitory mechanism and
stimulation of motor efferent fibers which activate the muscles.
The electrical stimulation used in the present invention is
provided in a biphasic or triphasic pattern.
[0070] As used herein, the term "motor point" refers to an area of
tissue that can be electrically stimulated by lower levels of
electricity compared to surrounding areas. The motor point overlies
the innervated zone of a muscle where the motor nerve endings are
concentrated or where the nerve trunk enters the muscle. The motor
point is often used as a placement site for surface electrodes used
to stimulate the muscle.
[0071] As used herein, the term "tissue" refers to an aggregation
of morphologically similar cells and associated intercellular
matter acting together to perform one or more specific functions in
the body, including epithelial, connective, muscle, and neural
tissue.
[0072] As used herein, the term "treatment" refers to the treatment
for reducing joint compression, in a patient, such as a mammal
(particularly a human), which includes decreasing the length and
intensity of co-contraction of opposing muscle groups associated
with a joint as demonstrated by I-EMG, FFT, a combination thereof,
or measuring muscle tone.
[0073] As used herein, the term "agonist muscle" broadly refers to
a muscle that is resisted or counteracted by another muscle, the
"antagonist muscle." Examples of agonist/antagonist muscle pairs
include abductors/adductors, flexors/extensors,
supinators/pronators, protractors/retractors, and
evertors/inverters.
[0074] As used herein, the term "abductors" refers to muscles that
generally cause movement away from the body centerline while
"adductors" are muscles that generally cause movement toward the
body centerline.
[0075] As used herein, the term "flexors" refers to muscles that
generally reduce the angle of a joint, while "extensors" refers to
muscles that increase the angle of the joint. For example, both the
flexor carpi radialis and flexor carpi ulnaris are flexors of the
wrist. The extensor carpi radialis longus, in conjunction with
extensor carpi radialis brevis, is an extensor of the wrist.
[0076] As used herein, the term "pronator" refers to a muscle that
causes the twisting movement of the wrist that turns the palm from
facing front to facing back. The opposing movement, which turns the
palm from facing back to facing front, is directed by a
"supinator."
[0077] As used herein, the term "protractor" is a muscle that moves
a part of the body anterior in the horizontal plane while a
"retractor" muscle is involved in the reverse movement.
[0078] As used herein, the term "evertor" refers to a muscle
involved in the twisting motion of the foot that turns the sole
outward while the opposite movement of turning the sole inward is
performed by an "inverter" muscle.
[0079] Referring to FIG. 1, an exemplary embodiment of an
electrical stimulation device that may be used in accordance with
the method of the present invention is designated generally as
reference numeral 10. Electrical stimulation device 10 generally
comprises an electronic control unit 12 with a plurality of output
connectors 14, 16, which are connected to a plurality of output
cables 18, 20 and associated electrode pairs 18a, 18b, and 20a,
20b, respectively.
[0080] Although two output connectors 14, 16 are shown in FIG. 1,
it should be understood that electronic control unit 12 may include
any number of output connectors (such as one, two, six, or eight
output connectors) in accordance with the present invention.
[0081] Output cables 18, 20 each comprise any suitable type of
insulated conductive cable, such as a coaxial cable. In the
illustrated embodiment, output cable 18 includes a back section 22
with a connector 24 (such as a male jack) that attaches to output
connector 14, and a front section 26 that splits into a first split
end 26a and a second split end 26b. Similarly, output cable 20
includes a back section 28 with a connector 30 (such as a male
jack) that attaches to output connector 16, and a front section 32
that splits into a first split end 32a and a second split end 32b.
Of course, it should be understood that each of the output cables
18, 20 could alternatively be manufactured out of two separate
leads (instead of having a front section with split ends). In
addition, output cables 18, 20 could be connected directly to
electronic control unit 12 without the use of connectors.
[0082] As can be seen in FIG. 1, electrodes 18a, 18b are attached
to split ends 26a, 26b of output cable 18, respectively. Similarly,
electrodes 20a, 20b are attached to split ends 32a, 32b of output
cable 20, respectively. As such, output cable 18 and electrodes
18a, 18b together form a first output channel (referred to
hereinafter as "channel A"), and output cable 20 and electrodes
20a, 20b together form a second output channel (referred to
hereinafter as "channel B"). Although two channels are shown in
FIG. 1, it should be understood that any number of channels (e.g.,
four, six, or eight channels) may be used in accordance with the
present invention (provided, of course, that the number of channels
corresponds to the number of output connectors of electronic
control unit 12).
[0083] In the illustrated example, electrodes 18a and 20a each
comprise a relative positive electrode, and electrodes 18b and 20b
each comprise a relative negative electrode. As will be described
in greater detail herein below, each of the electrical pulses
applied to electrodes 18a, 18b and electrodes 20a, 20b may
comprise, for example, a monophasic waveform (which has absolute
polarity), a biphasic asymmetric waveform (which has relative
polarity), or a biphasic symmetric waveform (which has no
polarity). Thus, as used herein, the term "positive electrode"
refers to a relative positive electrode and the term "negative
electrode" refers to a relative negative electrode (regardless of
whether the electrical pulse comprises a monophasic waveform, an
asymmetric biphasic waveform, or a symmetric biphasic waveform
which behaves like the relative positive or relative negative
electrode during each phase of the waveform).
[0084] Electrodes 18a, 18b and 20a, 20b are each adapted to be
positioned in electrical conduct with tissue of selected regions of
a patient, as will be described in greater detail herein below with
reference to FIG. 3A-3H. In the illustrated embodiment, each of
electrodes 18a, 18b and 20a, 20b comprises a transcutaneous
electrode having a surface electrode pad that may be placed on the
skin of a patient. As is known in the art, each of electrodes 18a,
18b, and 20a, 20b may be formed of metal or some other
physiologically acceptable conductive material and may take on a
variety of different sizes and shapes. Of course, one or more of
electrodes 18a, 18b and 20a, 20b may alternatively comprise a
percutaneous electrode, such as a needle electrode, or any other
type of suitable electrode in accordance with the present
invention.
[0085] Electronic control unit 12 also includes internal circuitry
(not shown) for selectively generating a series of electrical
pulses in accordance with a procedure for treating joint
compression. The series of electrical pulses generated by the
circuitry are provided at output connectors 14, 16 and, as such,
may be applied to a patient through channel A and/or channel B. The
series of electrical pulses may comprise a variety of different
types of pulse train patterns, such as: a plurality of cycles of a
biphasic sequential pulse train pattern; a plurality of cycles of a
biphasic overlapping pulse train pattern; a plurality of cycles of
a triphasic sequential pulse train pattern; or a plurality of
cycles of a triphasic overlapping pulse train pattern. Each of
these pulse train patterns will be described in detail herein below
with reference to FIGS. 2A-2D. One skilled in the art will
understand that a variety of different circuit configurations may
be used to generate the various pulse train patterns, such as the
circuitry described in Palermo, U.S. Pat. No. 5,562,718, which is
incorporated herein by reference.
[0086] A variety of different electrical stimulation devices may be
used and/or adapted for use in accordance with the present
invention. For example, one may incorporate the protocols disclosed
herein into the Omnistim.RTM. FX.sup.2 patterned electrical
neuromuscular stimulator or the Omnistim.RTM. FX.sup.2 Pro
patterned electrical neuromuscular stimulator, both of which are
commercially available from Accelerated Care Plus, 4850 Joule
Street, Suite A-1, Reno, Nev. 89502. Of course, other types of
electrical stimulation devices could also be used, which are
generally available in the industry.
[0087] Referring now to FIGS. 2A-2D, examples of the various types
of pulse train patterns that may be used in accordance with the
present invention will now be described herein below. Preferably
each pulse train pattern has a duration of 60 milliseconds to 200
milliseconds. The stimulation is timed such that there is a delay
between pulse train patterns of 400 milliseconds to 1200
milliseconds. The delay is short enough not to create a startle
response in the muscle and long enough to provide sufficient muscle
relaxation and recovery. Preferably, the pulse train pattern is
applied to the patient for a total treatment time of approximately
10 minutes to 60 minutes (and most preferably about 20 minutes to
30 minutes), as desired for a particular treatment.
[0088] Each of the pulse train patterns is comprised of a series of
individual electrical pulses arranged into a particular pattern.
Each of the electrical pulses may comprise either a monophasic or
biphasic waveform, which may be, for example, asymmetric,
symmetric, square, sinusoidal, and the like. Preferably, each of
the electrical pulses comprises a biphasic asymmetric square wave
having a pulse duration that ranges between 30 microseconds and 100
microseconds during the positive phase and a current amplitude that
typically ranges between 25 milliamps and 140 milliamps.
[0089] Biphasic Sequential Pulse Train Pattern
[0090] Referring to FIG. 2A, electrical stimulation device 10 may
be used to apply a plurality of cycles of a biphasic sequential
pulse train pattern to a patient. In a typical biphasic sequential
pulse train pattern, a first phase of electrical pulses is applied
to channel A and a second phase of electrical pulses is applied to
channel B with a delay period there between.
[0091] In the illustrated example, the first phase of electrical
pulses is applied to channel A for approximately 60 milliseconds to
120 milliseconds (and most preferably about 100 milliseconds). At
the conclusion of the first phase of electrical pulses, there is a
delay period of approximately 0 milliseconds to 100 milliseconds
(and most preferably about 80 milliseconds) before the second phase
of electrical pulses is applied to channel B. Then, the second
phase of electrical pulses is applied to channel B for
approximately 60 milliseconds to 120 milliseconds (and most
preferably about 100 milliseconds). The frequency of the individual
electrical pulses in each phase is approximately 30 Hz to 100 Hz
(and most preferably about 50 Hz).
[0092] Biphasic Overlapping Pulse Train Pattern
[0093] Referring to FIG. 2B, electrical stimulation device 10 may
also be used to apply a plurality of cycles of a biphasic
overlapping pulse train pattern to a patient. In a typical biphasic
overlapping pulse train pattern, a first phase of electrical pulses
is applied to channel A and a second phase of electrical pulses is
applied to channel B with an overlap there between.
[0094] In the illustrated example, the first phase of electrical
pulses is applied to channel A for approximately 60 milliseconds to
120 milliseconds (and most preferably about 100 milliseconds). When
the first phase of electrical pulses has reached a time period of
between 40 milliseconds and 100 milliseconds (and most preferably
about 80 milliseconds), the second phase of electrical pulses is
applied to channel B for approximately 60 milliseconds to 120
milliseconds (and most preferably about 100 milliseconds). Thus,
there is an overlap of approximately 20 milliseconds to 80
milliseconds (and most preferably about 20 milliseconds) during
which both channel A and channel B are providing electrical
stimulation to the patient. The frequency of the individual
electrical pulses in each phase is approximately 30 Hz to 100 Hz
(and most preferably about 50 Hz).
[0095] Triphasic Sequential Pulse Train Pattern
[0096] Referring to FIG. 2C, electrical stimulation device 10 may
also be used to apply a plurality of cycles of a triphasic
sequential pulse train pattern to a patient. In a typical triphasic
sequential pulse train pattern, a first phase of electrical pulses
is applied to channel A, a second phase of electrical pulses is
applied to channel B, and a third phase of electrical pulses is
applied to channel A, wherein there is a delay period between the
first and second phases of electrical pulses and another delay
period between the second and third phases of electrical
pulses.
[0097] In the illustrated example, the first phase of electrical
pulses is applied to channel A for approximately 60 milliseconds to
120 milliseconds (and most preferably about 100 milliseconds). At
the conclusion of the first phase of electrical pulses, there is a
delay period of approximately 0 milliseconds to 100 milliseconds
(and most preferably about 80 milliseconds) before the second phase
of electrical pulses is applied to channel B. Then, the second
phase of electrical pulses is applied to channel B for
approximately 60 milliseconds to 120 milliseconds (and most
preferably about 100 milliseconds). At the conclusion of the second
phase of electrical pulses, there is a delay period of
approximately 0 milliseconds to 100 milliseconds (and most
preferably about 80 milliseconds) before the third phase of
electrical pulses is applied to channel A. Then, the third phase of
electrical pulses is applied to channel A for approximately 36
milliseconds to 72 milliseconds (and most preferably about 60
milliseconds). The frequency of the individual electrical pulses in
each phase is approximately 30 Hz to 100 Hz (and most preferably
about 50 Hz).
[0098] Triphasic Overlapping Pulse Train Pattern
[0099] Referring to FIG. 2D, electrical stimulation device 10 may
also be used to apply a plurality of cycles of a triphasic
overlapping pulse train pattern to a patient. In a typical
triphasic overlapping pulse train pattern, a first phase of
electrical pulses is applied to channel A, a second phase of
electrical pulses is applied to channel B, and a third phase of
electrical pulses is applied to channel A, wherein there is an
overlap period between the first and second phases of electrical
pulses and another overlap period between the second and third
phases of electrical pulses.
[0100] In the illustrated example, the first phase of electrical
pulses is applied to channel A for approximately 60 milliseconds to
120 milliseconds (and most preferably about 100 milliseconds). When
the first phase of electrical pulses has reached a time period of
between 40 milliseconds and 100 milliseconds (and most preferably
about 80 milliseconds), the second phase of electrical pulses is
applied to channel B for approximately 60 milliseconds to 120
milliseconds (and most preferably about 100 milliseconds). Thus,
there is an overlap period of approximately 20 milliseconds to 80
milliseconds (and most preferably about 20 milliseconds) during
which both channel A and channel B are providing electrical
stimulation to the patient. When the second phase of electrical
pulses has reached a time period of between 40 milliseconds and 100
milliseconds (and most preferably about 80 milliseconds), the third
phase of electrical pulses is applied to channel A for
approximately 36 milliseconds to 72 milliseconds (and most
preferably about 60 milliseconds) (i.e., the third phase of
electrical pulses has a shorter time duration than that of the
first phase of electrical pulses). Thus, there is an overlap of
approximately 20 milliseconds to 72 milliseconds (and most
preferably about 20 milliseconds) during which both channel B and
channel A are providing electrical stimulation to the patient. The
frequency of the individual electrical pulses in each phase is
approximately 30 Hz to 100 Hz (and most preferably about 50
Hz).
[0101] Referring now to FIG. 3A-30, electrodes 18a, 18b and 20a,
20b are each adapted to be positioned in electrical contact with
tissue of selected regions of a patient. The selected regions are
preferably those that will assist in programming the central
pattern generators associated with the muscles associated with
opposing joint movement such as agonist/antagonist muscle pairs in
the neck, trunk, shoulder, arm, wrist, hand, hip, thigh, lower leg,
ankle, and foot of the patient that control intervertebral, elbow,
shoulder, wrist, ankle, knee, and hip joint movement. In the
present invention, the muscle contractions produced by the pulse
train patterns provide afferent inputs or efferent stimulation that
assist in retraining the central nervous system and spinal motor
loops to promote normal muscle function and decrease
co-contraction. Importantly, it is theorized that biphasic and
triphasic pulse train pattern stimulation assists in retraining
central pattern generators when functional pulse train patterns
cannot be created either because of the difficulty in assessing the
muscle groups involved or the research is too time consuming and
costly.
[0102] The electrical stimulation methods for reducing joint
compression of the present invention are well-adapted to be used
with other conventional therapies for overall joint health,
including, but not limited to: implementing a supervised exercise
program involving low-impact activities such as walking, swimming,
and cycling; maintaining an ideal body weight; rest periods;
applications of heat and cold; applications of light or laser;
application of pulsed or continuous magnetic fields; application of
electrostimulation for pain management; nonsteroidal
anti-inflammatory drugs (NSAIDS) or analgesics such as
acetaminophen, ibuprofen, naproxen, or aspirin; tramadol; codeine;
propoxyphene; glucosamine; chondroitin sulfate; salicylates; Cox-2
NSAIDS; surface application of capsaicin cream 0.25%;
intra-articular injections of steroids, corticosteroids, or
hyaluronic acid preparations; bracing, splinting, or orthotic
treatments; and surgery including joint replacement and
arthroscopic procedures.
[0103] While several exemplary embodiments of the present invention
are discussed below, those skilled in the art will readily
appreciate that various modifications may be made to these
embodiments, and the invention is not limited to the specific
electrode placements and pulse train patterns described
therein.
First Exemplary Embodiment
[0104] In a first exemplary embodiment of the present invention, as
generally illustrated in FIG. 3A, a pair of electrodes is
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with intervertebral and shoulder joint movement. A
second pair of electrodes is positioned bilaterally in a similar
manner.
[0105] More specifically, as shown in FIG. 3A, a two-channel system
is used to apply electrical stimulation to agonist/antagonist
muscles involved in neck intervertebral and shoulder joint
movement. For the first channel, a first electrode 18a is
positioned in electrical contact with tissue to stimulate a motor
point of the patient's upper trapezius muscle. Most preferably,
first electrode 18a comprises a surface electrode that is
positioned on the patient's skin along the midpoint of the upper
trapezius. A second electrode 18b is positioned is electrical
contact with tissue to stimulate a motor point of the patient's
cervical paraspinal muscles. Most preferably, second electrode 18b
comprises a surface electrode that is positioned on the patient's
skin in the posterior neck region just lateral to one or more of
cervical vertebrae, most preferably near the C1, C2, C3, and/or C4
cervical vertebrae. For the second channel, a second pair of
electrodes 20a, 20b is provided bilaterally in a similar position
as generally illustrated in FIG. 3A.
[0106] In this exemplary embodiment, the pulse train pattern
comprises a biphasic overlapping pulse train pattern having the
following parameters:
[0107] Pulse duration of individual electrical pulses: 50-70
microseconds
[0108] Current amplitude of individual electrical pulses: 20-70
milliamps
[0109] Duration of first phase: 100 milliseconds
[0110] Duration of overlap: 20 milliseconds
[0111] Duration of second phase: 100 milliseconds
[0112] Frequency of pulse train pattern: 1.6 Hz
[0113] Total treatment time: 20 minutes
[0114] Total number of treatments: 18 over six weeks
[0115] Frequency of individual electrical pulses (in each phase):
50 Hz
Second Exemplary Embodiment
[0116] In a second exemplary embodiment of the present invention,
as generally illustrated in FIG. 3B, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with intervertebral and shoulder joint movement
[0117] More specifically, as shown in FIG. 3B, a two-channel system
is used to apply electrical stimulation to agonist/antagonist
muscles involved in neck intervertebral and shoulder joint
movement. For the first channel, a first electrode 18a is
positioned in electrical contact with tissue to stimulate a motor
point of the patient's lower cervical and upper thoracic paraspinal
muscles. Most preferably, first electrode 18a comprises a surface
electrode that is positioned on the patient's skin along the
midpoint of the upper trapezius just lateral to the spinal cord,
most preferably near the C6, C7, T1, T2, T3, and/or T4 cervical and
thoracic vertebrae. A second electrode 18b is positioned in
electrical contact with tissue to stimulate a motor point of the
patient's cervical paraspinal muscles. Most preferably, second
electrode 18b comprises a surface electrode that is positioned on
the patient's skin in the posterior neck region just lateral to one
or more cervical vertebrae, most preferably near the C1, C2, C3,
and/or C4 cervical vertebrae. For the second channel, a second pair
of electrodes 20a, 20b is provided bilaterally in a similar
position as generally illustrated in FIG. 3B.
[0118] In this exemplary embodiment, the pulse train pattern
comprises a biphasic overlapping pulse train pattern having the
following parameters:
[0119] Pulse duration of individual electrical pulses: 50-70
microseconds
[0120] Current amplitude of individual electrical pulses: 20-70
milliamps
[0121] Duration of first phase: 100 milliseconds
[0122] Duration of overlap: 20 milliseconds
[0123] Duration of second phase: 100 milliseconds
[0124] Frequency of pulse train pattern: 1.6 Hz
[0125] Total treatment time: 20 minutes
[0126] Total number of treatments: 18 (over six weeks)
[0127] Frequency of individual electrical pulses (in each phase):
50 Hz
Third Exemplary Embodiment
[0128] In a third exemplary embodiment of the present invention, as
generally illustrated in FIG. 3C, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with intervertebral joint movement.
[0129] More specifically, as shown in FIG. 3C, a two channel system
is used to apply electrical stimulation to agonist/antagonist
muscles involved in upper and mid-back intervertebral joint
movement including the erector spinae and trapezius muscles. For
the first channel, a first electrode 18a is positioned in
electrical contact with tissue to stimulate a motor point of the
patient's thoracic paraspinal muscles. Most preferably, first
electrode 18a comprises a surface electrode that is positioned on
the patient's skin just lateral to one or more thoracic vertebrae,
most preferably near the T3, T4, T5, T6, T7, T8, and/or T9 thoracic
vertebrae. A second electrode 18b is positioned in electrical
contact with tissue to stimulate a motor point of the patient's
upper thoracic paraspinal muscles. Most preferably, second
electrode 18a comprises a surface electrode that is positioned on
the patient's skin along the midpoint of the upper trapezius just
lateral to the spinal cord, most preferably near the C7, T1, T2,
T3, and/or T4 cervical and thoracic vertebrae. For the second
channel, a second pair of electrodes 20a, 20b is provided
bilaterally in a similar position as generally illustrated in FIG.
3C.
[0130] In this exemplary embodiment, the pulse train pattern
comprises a biphasic overlapping pulse train pattern having the
following parameters:
[0131] Pulse duration of individual electrical pulses: 50-70
microseconds
[0132] Current amplitude of individual electrical pulses: 20-70
milliamps
[0133] Duration of first phase: 100 milliseconds
[0134] Duration of overlap: 20 milliseconds
[0135] Duration of second phase: 100 milliseconds
[0136] Frequency of pulse train pattern: 1.6 Hz
[0137] Total treatment time: 20 minutes
[0138] Total number of treatments: 36
[0139] Frequency of individual electrical pulses (in each phase):
50 Hz
Fourth Exemplary Embodiment
[0140] In a fourth exemplary embodiment of the present invention,
as generally illustrated in FIG. 3D, a pair of electrodes is
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with intervertebral joint movement. A second pair of
electrodes is positioned bilaterally in a similar manner.
[0141] More specifically, as shown in FIG. 3D, a two-channel system
is used to apply electrical stimulation to agonist/antagonist
muscles involved in lumbar intervertebral joint movement. For the
first channel, a first electrode 18a is positioned in electrical
contact with tissue to stimulate a motor point of the patient's
lower back muscles. Most preferably, first electrode 18a comprises
a surface electrode that is positioned posteriorly on the patient's
skin in the lower back region over the lower paraspinal muscles
just lateral to one or more of the lower thoracic and/or lumbar
vertebrae, most preferably near the L1, L2, L3, L4, and/or L5
lumbar vertebrae. A second electrode 18b is positioned in
electrical contact with tissue to stimulate a motor point of the
patient's abdominal muscles. Most preferably, second electrode 18b
comprises a surface electrode that is positioned anteriorly on the
patient's skin at about the level of the umbilicus, about half-way
between the anterior superior iliac spine ("ASIS") and the anterior
midline over the combined abdominal muscle. For the second channel,
a second pair of electrodes 20a, 20b is provided bilaterally in a
similar position as generally illustrated in FIG. 3D.
[0142] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0143] Pulse duration of individual electrical pulses: 50-70
microseconds
[0144] Current amplitude of individual electrical pulses: 20-90
milliamps
[0145] Duration of first phase: 200 milliseconds
[0146] Duration of overlap: 40 milliseconds
[0147] Duration of second phase: 200 milliseconds
[0148] Duration of overlap: 40 milliseconds
[0149] Duration of third phase: 120 milliseconds
[0150] Frequency of pulse train pattern: 0.67 Hz
[0151] Frequency of individual electrical pulses (in each phase):
50 hertz
[0152] Total treatment time: 20 minutes
[0153] Total number of treatments: 18 over six weeks
Fifth Exemplary Embodiment
[0154] In a fifth exemplary embodiment of the present invention, as
generally illustrated in FIG. 3E, four pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with intervertebral joint movement. Two channels may be
used with a bifurcating cable as illustrated in FIG. 3E.
[0155] More specifically, as shown in FIG. 3E, a two-channel system
is used to apply electrical stimulation to agonist/antagonist
muscles involved in trunk intervertebral joint movement. For the
first channel, a first electrode 18a is positioned in electrical
contact with tissue to stimulate a motor point of the patient's
upper lumbar and upper abdominal muscles. Most preferably, first
electrode 18a comprises a surface electrode that is positioned
posteriorly on the patient's skin in the lower back region over the
multifidus muscle, just lateral to one or more of the lower
thoracic and/or lumbar vertebrae, most preferably near the L1, L2,
L3, L4, and/or L5 lumbar vertebrae. A second electrode 18b of the
first channel is also placed posteriorly on the patient's skin in
the lower back region over the multifidus muscle, just lateral to
one or more of the lower thoracic and/or lumbar vertebrae, most
preferably near the T9, T10, T11, T12, L1, L2, and/or L3 lumbar
vertebrae. A third electrode 18c and a fourth electrode 18d are
placed over the same side of the abdominal muscles at the same
vertebral level to stimulate the patient's lower abdominal muscles.
Another set of four electrodes 20a, 20b, 20c, and 20d is provided
bilaterally in a similar position as generally illustrated in FIG.
3E.
[0156] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0157] Pulse duration of individual electrical pulses: 50-70
microseconds
[0158] Current amplitude of individual electrical pulses: 20-70
milliamps
[0159] Duration of first phase: 200 milliseconds
[0160] Duration of overlap: 40 milliseconds
[0161] Duration of second phase: 200 milliseconds
[0162] Duration of overlap: 40 milliseconds
[0163] Duration of third phase: 120 milliseconds
[0164] Frequency of pulse train pattern: 0.67 Hz
[0165] Frequency of individual electrical pulses (in each phase):
50 Hz
[0166] Total treatment time: 20 minutes
[0167] Total number of treatments: 18 over six weeks
Sixth Exemplary Embodiment
[0168] In a sixth exemplary embodiment of the present invention,
also generally illustrated in FIG. 3F, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with elbow flexion/extension.
[0169] More specifically, as shown in FIG. 3F, a two-channel system
is used to apply electrical stimulation to muscles of the upper
arm. For the first channel, a first electrode 18a and a second
electrode 18b are positioned in electrical contact with tissue to
stimulate motor points of the patient's biceps brachii muscles
(flex the forearm at the elbow). Most preferably, first electrode
18a comprises a surface electrode that is positioned on the
patient's skin on the anterior side of the upper arm just above the
insertion of the biceps brachii muscles. Most preferably, second
electrode 18b comprises a surface electrode that is positioned on
the patient's skin on the anterior side of the upper arm just below
the origin of the biceps brachii muscles.
[0170] For the second channel, a first electrode 20a and a second
electrode 20b are positioned in electrical contact with tissue to
stimulate motor points of the patient's triceps brachii muscles
(extend the forearm at the elbow). Most preferably, first electrode
20a comprises a surface electrode that is positioned on the
patient's skin on the posterior side of the upper arm above the
insertion of the triceps brachii muscles. Most preferably, second
electrode 20b comprises a surface electrode that is positioned on
the patient's skin on the posterior side of the upper arm below the
origin of the triceps brachii muscles.
[0171] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied to the upper arm as discussed more fully below. It will be
appreciated that the muscles involved in elbow flexion/extension
may be bilaterally stimulated when the electrical stimulation
device contains at least four channels. Alternatively, two
electrical stimulation devices can be used for bilateral
stimulation: one to stimulate the right upper arm, and one to
stimulate the left upper arm.
[0172] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0173] Pulse duration of individual electrical pulses: 50-70
microseconds
[0174] Current amplitude of individual electrical pulses: 30-70
milliamps
[0175] Duration of first phase: 100 milliseconds
[0176] Duration of overlap between first and second phases: 20
milliseconds
[0177] Duration of second phase: 100 milliseconds
[0178] Duration of overlap between second and third phases: 20
milliseconds
[0179] Duration of third phase: 60 milliseconds
[0180] Frequency of pulse train pattern: 0.67 Hz
[0181] Total treatment time: 20 minutes
[0182] Total number of treatments: 18 during six weeks
[0183] Frequency of individual electrical pulses (in each phase):
50 Hz
Seventh Exemplary Embodiment
[0184] In a seventh exemplary embodiment of the present invention,
as generally illustrated in FIG. 3G, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
involved in the internal and external rotation of the shoulder.
[0185] More specifically, as shown in FIG. 3G, a two channel system
is used to apply electrical stimulation to agonist/antagonist
muscles involved in shoulder movement. For the first channel, a
first pair of electrodes 18a, 18b is positioned to provide
simulation to muscles involved in the internal rotation of the
shoulder. A first electrode 18a is positioned in electrical contact
with tissue to stimulate a motor point of the patient's biceps
brachii muscle. Most preferably, first electrode 18a comprises a
surface electrode that is positioned on the patient's skin near the
midpoint of the biceps brachii muscle. A second electrode 18b is
positioned in electrical contact with tissue to stimulate a motor
point of the patient's pectoralis major and anterior deltoid
muscle. Most preferably, second electrode 18b comprises a surface
electrode that is positioned anteriorly on the patient's skin just
above the axilla.
[0186] For the second channel, a second pair of electrodes 20a, 20b
is provided to stimulate the muscles involved in the external
rotation of the shoulder. A first electrode 20a is positioned in
electrical contact with tissue to stimulate a motor point of the
patient's triceps brachii muscle. Most preferably, first electrode
20a comprises a surface electrode that is positioned near the
midpoint of the triceps brachii. A second electrode 20b is
positioned in electrical contact with tissue to stimulate a motor
point of the patient's infraspinatus teres minor and the posterior
deltoid muscle. Most preferably, second electrode 20b comprises a
surface electrode that is positioned posteriorly on the patient's
skin just above the underarm.
[0187] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied as discussed more fully below. It will be appreciated that
the muscles involved in shoulder rotation may be bilaterally
stimulated when the electrical stimulation device contains at least
four channels. Alternatively, two electrical stimulation devices
can be used for bilateral stimulation: one to simulate the right
shoulder, and one to stimulate the left shoulder.
[0188] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0189] Pulse duration of individual electrical pulses: 50-70
microseconds
[0190] Current amplitude of individual electrical pulses: 30-70
milliamps
[0191] Duration of first phase: 100 milliseconds
[0192] Duration of overlap: 20 milliseconds
[0193] Duration of second phase: 100 milliseconds
[0194] Duration of overlap: 20 milliseconds
[0195] Duration of third phase: 60 milliseconds
[0196] Frequency of pulse train pattern: 0.67 Hz
[0197] Total treatment time: 20 minutes
[0198] Total number of treatments: 18 over six weeks
[0199] Frequency of individual electrical pulses (in each phase):
50 Hz
Eighth Exemplary Embodiment
[0200] In an eighth exemplary embodiment of the present invention,
as generally illustrated in FIG. 3H, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
involved in shoulder and elbow flexion/extension.
[0201] More specifically, as shown in FIG. 3H, a two-channel system
is used to apply electrical stimulation to agonist/antagonist
muscles involved in shoulder and elbow extension/flexion. For the
first channel, a first electrode 18a is positioned in electrical
contact with tissue to stimulate a motor point of the patient's
biceps brachii muscle. Most preferably, first electrode 18a
comprises a surface electrode that is positioned on the patient's
skin near the midpoint of the biceps brachii muscle. A second
electrode 18b is positioned in electrical contact with tissue to
stimulate a motor point of the patient's anterior deltoid muscle.
Most preferably, second electrode 18b comprises a surface electrode
that is positioned anteriorly on the patient's skin just above the
axilla.
[0202] For the second channel, a first electrode 20a is positioned
in electrical contact with tissue to stimulate a motor point of the
patient's triceps brachii muscle. Most preferably, first electrode
20a comprises a surface electrode that is positioned near the
distal end of the triceps brachii. A second electrode 20b is
positioned in electrical contact with tissue to stimulate a motor
point of the patient's posterior deltoid muscle. Most preferably,
second electrode 20b comprises a surface electrode that is
positioned posteriorly on the patient's skin just above the
axilla.
[0203] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied as discussed more fully below. It will be appreciated that
the muscles involved in shoulder rotation may be bilaterally
stimulated when the electrical stimulation device contains at least
four channels. Alternatively, two electrical stimulation devices
can be used for bilateral stimulation: one to simulate the right
shoulder, and one to stimulate the left shoulder.
[0204] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0205] Pulse duration of individual electrical pulses: 50-70
microseconds
[0206] Current amplitude of individual electrical pulses: 30-70
milliamps
[0207] Duration of first phase: 100 milliseconds
[0208] Duration of overlap: 20 milliseconds
[0209] Duration of second phase: 100 milliseconds
[0210] Duration of overlap: 20 milliseconds
[0211] Duration of third phase: 60 milliseconds
[0212] Frequency of pulse train pattern: 0.67 Hz
[0213] Total treatment time: 20 minutes
[0214] Total number of treatments: 18 (over six weeks)
[0215] Frequency of individual electrical pulses (in each phase):
50 Hz
Ninth Exemplary Embodiment
[0216] In a ninth exemplary embodiment of the present invention,
also generally illustrated in FIG. 3I, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with wrist flexion/extension, wrist
pronation/supination, and/or finger flexion/extension. The treated
muscles include the flexor digitorum superficialis, flexor carpi
radialis, flexor carpi ulnaris, extensor digitorum. extensor digiti
minimi muscle, extensor carpi ulnaris, extensor carpi radialis
longus, and/or extensor carpi radialis brevis.
[0217] More specifically, as shown in FIG. 3I, a two-channel system
is used to apply electrical stimulation to muscles of the wrist and
fingers. For the first channel, a first electrode 18a is positioned
in electrical contact with tissue of the patient's proximal palmar
surface to stimulate motor points of the patient's intrinsic hand
muscles. Most preferably, first electrode 18a comprises a surface
electrode that is positioned on the patient's skin across the
thenar and the hypothenar eminence on the palmar/anterior side of
the forearm arm at the base of the wrist just below the wrist
crease. A second electrode 18b is positioned in electrical contact
with tissue to stimulate motor points of the patient's
volar-surface, proximal forearm muscles. Most preferably, second
electrode 18b comprises a surface electrode that is positioned on
the patient's skin on the palmar/anterior side of the lower arm
just below the elbow joint.
[0218] For the second channel, a first electrode 20a is positioned
in electrical contact with tissue to stimulate a motor point of the
patient's extensor digitorum muscle (extends medial four digits at
metacarpophalangeal joints, and extends the hand at the wrist) and
pollicis muscles. Most preferably, first electrode 20a comprises a
surface electrode that is positioned on the patient's skin on the
dorsal/posterior side of the lower arm on the distal one-third
between the wrist crease and the elbow joint. A second electrode
20b is positioned in electrical contact with a tissue to stimulate
motor points of the patient's proximal extensor muscles of the
forearm. Most preferably, second electrode 20b comprises a surface
electrode that is positioned on the patient's skin on the
dorsal/posterior side of the lower arm just below the elbow
joint.
[0219] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied to the arm and wrist as discussed more fully below. It will
be appreciated that the muscles involved in wrist and finger
extension/flexion may be bilaterally stimulated when the electrical
stimulation device contains at least four channels.
[0220] Alternatively, two electrical stimulation devices can be
used for bilateral stimulation: one to stimulate the right wrist
and fingers, and one to stimulate the left wrist and fingers.
[0221] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0222] Pulse duration of individual electrical pulses: 50-70
microseconds
[0223] Current amplitude of individual electrical pulses: 30-70
milliamps
[0224] Duration of first phase: 100 milliseconds
[0225] Duration of overlap between first and second phases: 20
milliseconds
[0226] Duration of second phase: 100 milliseconds
[0227] Duration of overlap between second and third phases: 20
milliseconds
[0228] Duration of third phase: 60 milliseconds
[0229] Frequency of pulse train pattern: 0.67 Hz
[0230] Total treatment time: 20 minutes
[0231] Total number of treatments: 18 during six weeks
[0232] Frequency of individual electrical pulses (in each phase):
50 Hz
Tenth Exemplary Embodiment
[0233] In a tenth exemplary embodiment of the present invention,
also generally illustrated in FIG. 3J, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
involved in wrist and elbow movement.
[0234] More specifically, as shown in FIG. 3J, a two-channel system
is used to apply electrical stimulation to agonist/antagonist
muscles involved in wrist and elbow movement. For the first
channel, a first pair of electrodes 18a, 18b provide stimulation to
the anterior portion of the arm. A first electrode 18a is
positioned in electrical contact with tissue of the proximal palmar
surface to stimulate a motor point of the patient's intrinsic hand
muscles. Most preferably, first electrode 18a comprises a surface
electrode that is positioned on the patient's skin across the
thenar and hypothenar eminence of the palmar/anterior side of the
forearm at the base of the wrist just below the wrist crease. A
second electrode 18b is positioned in electrical contact with
tissue to stimulate a motor point of the patient's biceps brachii
muscles, the median nerve, and the ulnar nerve. Most preferably,
second electrode 18b comprises a surface electrode that is
positioned on the patient's skin anterior and medially (to capture
the median and ulnar nerve bundle) near the midpoint of the biceps
brachii muscles.
[0235] For the second channel, a second pair of electrodes 20a, 20b
is provided to stimulate the posterior muscles of the arm. A first
electrode 20a is positioned in electrical contact with tissue to
stimulate a motor point of the patient's proximal extensor muscles
of the forearm. Most preferably, first electrode 20a comprises a
surface electrode that is positioned on the patient's skin on the
dorsal/posterior side of the lower arm just below the elbow joint.
A second electrode 20b is positioned in electrical contact with
tissue to stimulate a motor point of the patient's triceps brachii
muscles. Most preferably, second electrode 20b comprises a surface
electrode that is positioned on the patient's skin on the posterior
side of the arm near the midpoint of the triceps brachii
muscles.
[0236] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied to the arm and wrist as discussed more fully below. It will
be appreciated that the muscles involved in arm movement may be
bilaterally stimulated when the electrical stimulation device
contains at least four channels. Alternatively, two electrical
stimulation devices can be used for bilateral stimulation: one to
stimulate the right arm, and one to stimulate the left arm.
[0237] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0238] Pulse duration of individual electrical pulses: 50-70
microseconds
[0239] Current amplitude of individual electrical pulses: 30-70
milliamps
[0240] Duration of first phase: 100 milliseconds
[0241] Duration of overlap between first and second phases: 20
milliseconds
[0242] Duration of second phase: 100 milliseconds
[0243] Duration of overlap between second and third phases: 20
milliseconds
[0244] Duration of third phase: 60 milliseconds
[0245] Frequency of pulse train pattern: 0.67 Hz
[0246] Total treatment time: 20 minutes
[0247] Total number of treatments: 18 during six weeks
[0248] Frequency of individual electrical pulses (in each phase):
50 Hz
Eleventh Exemplary Embodiment
[0249] In an eleventh exemplary embodiment of the present
invention, as generally illustrated in FIG. 3K, two pairs of
electrodes are positioned in electrical contact with the patient's
tissue in order to provide electrical stimulation to one or more of
the muscles associated with toe and ankle dorsiflexion (or
extension) and flexion (or plantar flexion).
[0250] More specifically, as shown in FIG. 3K, a two-channel system
is used to apply electrical stimulation to agonist/antagonist
muscles involved in toe and ankle extension/flexion. For the first
channel, a first electrode 18a is positioned in electrical contact
with tissue to stimulate a motor point of the patient's extensor
digitorum brevis muscle (extends the joints of the proximal
phalanges of toes 1-4). Most preferably, first electrode 18a
comprises a surface electrode that is positioned on the patient's
skin on the dorsum of the foot over the first four metatarsal
bones. A second electrode 18b is positioned in electrical contact
with tissue to stimulate a motor point of the patient's tibialis
anterior (extends foot at the ankle), extensor digitorum longus
(extends toes 2-5 and the foot at the ankle), and/or extensor
hallucis longus (extends toe 1 and the foot at the ankle) muscles.
Most preferably, second electrode 18b comprises a surface electrode
that is positioned on the patient's skin at the anterior lateral
mid-shaft of the leg over the mid-tibialis anterior and the
approximate mid-belly of the extensor digitorum longus and extensor
hallucis longus muscles.
[0251] For the second channel, a first electrode 20a is positioned
in electrical contact with tissue to stimulate motor points of the
patient's intrinsic foot muscles. Most preferably, first electrode
20a comprises a surface electrode that is positioned on the
patient's skin on the sole of the foot at the anterior one-third
junction to include the abductor hallucis. A second electrode 20b
is positioned in electrical contact with tissue to stimulate motor
points of the patient's tibialis posterior (flexes the foot at the
ankle) and flexor hallucis muscles. Most preferably, second
electrode 20b comprises a surface electrode that is positioned on
the patient's skin on the posterior distal one-third of the lower
leg.
[0252] During treatment, the first and second channels are
positioned on the right or left leg, and a patterned pulse train is
applied to the leg as discussed more fully below. It will be
appreciated that the muscles involved in toe and ankle
extension/flexion may be bilaterally stimulated when the electrical
stimulation device contains at least four channels. Alternatively,
two electrical stimulation devices can be used for bilateral
stimulation: one to stimulate the right leg, and one to stimulate
the left leg.
[0253] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0254] Pulse duration of individual electrical pulses: 50-70
microseconds
[0255] Current amplitude of individual electrical pulses: 30-70
milliamps
[0256] Duration of first phase: 200 milliseconds
[0257] Duration of overlap between first and second phase: 40
milliseconds
[0258] Duration of second phase: 200 milliseconds
[0259] Duration of overlap between second and third phase: 40
milliseconds
[0260] Duration of third phase: 120 milliseconds
[0261] Frequency of pulse train pattern: 0.67 Hz
[0262] Total treatment time: 20 minutes
[0263] Total number of treatments: 18 during six weeks
[0264] Frequency of individual electrical pulses (in each phase):
50 Hz
Twelfth Exemplary Embodiment
[0265] In a twelfth exemplary embodiment of the present invention,
generally illustrated in FIG. 3L, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with ankle dorsiflexion and plantar flexion and ankle
eversion/inversion.
[0266] More specifically, as shown in FIG. 3L, a two-channel system
is used to apply electrical stimulation to muscles involved in
ankle dorsiflexion and plantar flexion and/or ankle
inversion/eversion. For the first channel (panel 1 of FIG. 3L), a
first electrode 18a is positioned in electrical contact with tissue
to stimulate a motor point of the patient's lower portion of the
tibialis anterior muscle. Most preferably, first electrode 18a
comprises a surface electrode that is positioned on the patient's
skin over the mid-belly of the tibialis anterior muscle. A second
electrode 18b is positioned in electrical contact with tissue to
stimulate a motor point of the patient's proximal tibialis anterior
muscle. Most preferably, second electrode 18b comprises a surface
electrode that is positioned on the patient's skin inferior to the
fibular head.
[0267] Alternatively, for the first channel (panel 2 of FIG. 3L), a
first electrode 18a is positioned in electrical contact with tissue
to stimulate motor points of the patient's anterior and lateral
muscles of the leg. Most preferably, first electrode 18a comprises
a surface electrode that is positioned on the patient's skin at the
mid-belly of the tibialis anterior as well as the peroneus muscles.
A second electrode 18b is positioned in electrical contact with
tissue to stimulate a motor point of the patient's proximal
tibialis anterior muscle. Most preferably, second electrode 18b
comprises a surface electrode that is positioned on the patient's
skin inferior to the fibular head.
[0268] For the second channel (panel 3 of FIG. 3L), a first
electrode 20a and a second electrode 20b are positioned in
electrical contact with tissue to stimulate motor points of the
patient's triceps surae (comprised of the gastrocnemius medial head
(which plantar flexes the foot at the ankle), the gastrocnemius
lateral head (which plantar flexes foot at the ankle), and/or the
soleus muscle (which plantar flexes the foot at the ankle)). Most
preferably, first electrode 20a comprises a surface electrode that
is positioned on the patient's skin directly over the junction of
the gastrocnemius and soleus muscles. Most preferably, second
electrode 20b comprises a surface electrode that is positioned on
the patient's skin posteriorly just inferior to the popliteal fossa
over the tibial nerve and the two heads of the gastrocnemius
muscle.
[0269] During treatment, the first and second channels are
positioned on the right or left leg, and a patterned pulse train is
applied to the leg as discussed more fully below. It will be
appreciated that the muscles involved in ankle dorsiflexion and
plantar flexion and/or ankle inversion/eversion may be bilaterally
stimulated when the electrical stimulation device contains at least
four channels. Alternatively, two electrical stimulation devices
can be used for bilateral stimulation: one to stimulate the right
leg, and one to stimulate the left leg.
[0270] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0271] Pulse duration of individual electrical pulses: 50-70
microseconds
[0272] Current amplitude of individual electrical pulses: 30-70
milliamps
[0273] Duration of first phase: 200 milliseconds
[0274] Duration of overlap between first and second phase: 40
milliseconds
[0275] Duration of second phase: 200 milliseconds
[0276] Duration of overlap between second and third phase: 40
milliseconds
[0277] Duration of third phase: 120 milliseconds
[0278] Frequency of pulse train pattern: 0.67 Hz
[0279] Total treatment time: 20 minutes
[0280] Total number of treatments: 18 during six weeks
[0281] Frequency of individual electrical pulses (in each phase):
50 Hz
Thirteenth Exemplary Embodiment
[0282] In a thirteenth exemplary embodiment of the present
invention, also generally illustrated in FIG. 3M, two pairs of
electrodes are positioned in electrical contact with the patient's
tissue in order to provide electrical stimulation to one or more of
the muscles associated with movement in the lower extremities.
[0283] More specifically, as generally shown in FIG. 3M, a
two-channel system is used to apply electrical stimulation to
muscles involved in leg movement. For the first channel, a first
electrode 18a is positioned in electrical contact with tissue to
stimulate a motor point of the patient's proximal tibialis anterior
muscle. Most preferably, first electrode 18a comprises a surface
electrode that is positioned on the patient's skin on the anterior
side of the leg and inferior to the fibular head. A second
electrode 18b is positioned in electrical contact with tissue to
stimulate a motor point near the midpoint of a patient's quadriceps
muscles. Most preferably, second electrode 18b comprises a surface
electrode that is positioned on the patient's skin on the anterior
side of the leg just above the knee.
[0284] For the second channel, a first electrode 20a is positioned
in electrical contact with tissue to stimulate a motor point of the
patient's triceps surae muscles. Most preferably, first electrode
20a comprises a surface electrode that is positioned on the
patient's skin on the posterior side of the lower leg near the
midpoint of the gastrocnemius muscle. The second electrode 20b is
positioned in electrical contact with a tissue to stimulate a motor
point of the patient's mid-hamstrings. Most preferably, second
electrode 20b comprises a surface electrode that is positioned on
the patient's skin on the distal one third of the posterior side of
the leg.
[0285] During treatment, the first and second channels are
positioned on the right or left leg, and a patterned pulse train is
applied to the leg as discussed more fully below. It will be
appreciated that the muscles involved in leg movement may be
bilaterally stimulated when the electrical stimulation device
contains at least four channels. Alternatively, two electrical
stimulation devices can be used for bilateral stimulation: one to
stimulate the right leg, and one to stimulate the left leg.
[0286] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0287] Pulse duration of individual electrical pulses: 50-100
microseconds
[0288] Current amplitude of individual electrical pulses: 30-90
milliamps
[0289] Duration of first phase: 200 milliseconds
[0290] Duration of overlap between first and second phases: 40
milliseconds
[0291] Duration of second phase: 200 milliseconds
[0292] Duration of overlap between second and third phases: 40
milliseconds
[0293] Duration of third phase: 120 milliseconds
[0294] Frequency of pulse train pattern: 0.67 Hz
[0295] Total treatment time: 20 minutes
[0296] Total number of treatments: 18 during six weeks
[0297] Frequency of individual electrical pulses (in each phase):
50 Hz
Fourteenth Exemplary Embodiment
[0298] In a fourteenth exemplary embodiment of the present
invention, generally illustrated in FIG. 3N, a pair of electrodes
is positioned in electrical contact with the patient's tissue in
order to provide electrical stimulation to one or more of the
muscles associated with hip abduction and knee extension as well as
hip adduction and knee flexion (stabilization).
[0299] More specifically, as generally shown in FIG. 3N, a
two-channel system is used to apply electrical stimulation to
muscles involved in hip abduction/adduction and knee
extension/flexion. For the first channel, a first electrode 18a is
positioned in electrical contact with the quadricep muscles, and in
particular to stimulate the motor point of the vastus medialis,
which functions as an extensor of the knee. A second electrode 18b
is positioned in electrical contact with tissue to stimulate the
gluteus medius, gluteus minimus, and tensor faciae latae.
Preferably, the second electrode 18b is positioned about midway
between the iliac crest and the greater trochanter. For the second
channel, a first electrode 20a is positioned in electrical contact
with tissue to stimulate the patient's hamstring muscles (biceps
femoris, semitendinosus, and/or semimembraneous muscles). A second
electrode 20b is positioned in electrical contact with tissue to
stimulate the adductor magnus, adductor longus, adductor brevis,
and medial hamstring muscles.
[0300] The far right panel of FIG. 3N shows the hip extensor
alternative placement: In the second channel, a first electrode 20a
is positioned in electrical contact with tissue to stimulate the
adductor magnus, adductor longus, adductor brevis and medial
hamstring muscles. A second electrode 20b is positioned in
electrical contact with tissue to stimulate the mid-belly of the
gluteus maximus.
[0301] During treatment, the first and second channels are
positioned on the right or left leg, and a patterned pulse train is
applied to the leg as discussed more fully below. It will be
appreciated that the muscles involved in hip abduction/adduction
and knee extension/flexion may be bilaterally stimulated when the
electrical stimulation device contains at least four channels.
Alternatively, two electrical stimulation devices can be used for
bilateral stimulation: one to simulate the right leg, and one to
stimulate the left leg.
[0302] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0303] Pulse duration of individual electrical pulses: 50-200
microseconds
[0304] Current amplitude of individual electrical pulses: 30-140
milliamps
[0305] Duration of first phase: 200 milliseconds
[0306] Duration of overlap between first and second phase: 40
milliseconds
[0307] Duration of second phase: 200 milliseconds
[0308] Duration of overlap between second and third phase: 40
milliseconds
[0309] Duration of third phase: 120 milliseconds
[0310] Frequency of pulse train pattern: 0.67 Hz
[0311] Total treatment time: 20 minutes
[0312] Total number of treatments: 18 during six weeks
[0313] Frequency of individual electrical pulses (in each phase):
50 Hz
Fifteenth Exemplary Embodiment
[0314] In an eighth exemplary embodiment of the present invention,
also generally illustrated in FIG. 3O, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with knee extension/flexion as a treatment for joint
compression in the lower extremities.
[0315] More specifically, as generally shown in FIG. 3O, a
two-channel system is used to apply electrical stimulation to
muscles involved in knee extension/flexion. For the first channel,
a first electrode 18a is positioned in electrical contact with
tissue to stimulate a motor point of the patient's rectus femoris
(extends leg at the knee) and vastus lateralis (extends leg at the
knee) muscles. Most preferably, first electrode 18a comprises a
surface electrode that is positioned on the patient's skin on the
proximal one third of the anterior side of the upper leg. A second
electrode 18b is positioned in electrical contact with tissue to
stimulate the motor point of the patient's vastus medialis muscle
(extends the leg at the knee). Most preferably, second electrode
18b comprises a surface electrode that is positioned on the
patient's skin on the anterior medial side of the upper leg just
above the knee.
[0316] For the second channel, a first electrode 20a is positioned
in electrical contact with tissue to stimulate a motor point of the
patient's distal portion of the biceps femoris muscle (flexes the
leg at the knee), semimembranosus muscle (flexes the leg at the
knee), and/or semitendinosus muscle (flexes the leg at the knee).
Most preferably, first electrode 20a comprises a surface electrode
that is positioned on the patient's skin on the posterior side of
the upper leg just above the knee. A second electrode 20b is
positioned in electrical contact with a tissue to stimulate a motor
point of the patient's proximal portion of the biceps femoris,
semimembranosus, and/or semitendinosus muscles. Most preferably,
second electrode 20b comprises a surface electrode that is
positioned on the patient's skin on the proximal one third of the
posterior side of the upper leg.
[0317] During treatment, the first and second channels are
positioned on the right or left leg, and a patterned pulse train is
applied to the leg as discussed more fully below. It will be
appreciated that the muscles involved in knee flexion/extension may
be bilaterally stimulated when the electrical stimulation device
contains at least four channels. Alternatively, two electrical
stimulation devices can be used for bilateral stimulation: one to
stimulate the right leg, and one to stimulate the left leg.
[0318] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
[0319] Pulse duration of individual electrical pulses: 50-200
microseconds
[0320] Current amplitude of individual electrical pulses: 30-140
milliamps
[0321] Duration of first phase: 200 milliseconds
[0322] Duration of overlap between first and second phases: 40
milliseconds
[0323] Duration of second phase: 200 milliseconds
[0324] Duration of overlap between second and third phases: 40
milliseconds
[0325] Duration of third phase: 120 milliseconds
[0326] Frequency of pulse train pattern: 0.67 Hz
[0327] Total treatment time: 20 minutes
[0328] Total number of treatments: 18 during six weeks
[0329] Frequency of individual electrical pulses (in each phase):
50 Hz
Example 1
Measuring Muscle Hardness
[0330] In this example, muscle hardness was correlated to I-EMG
ratios. More specifically, fourteen healthy female subject were
seated in a fixed position, and postured with the hip joint at a 60
degree angle, with the body trunk fixed by a belt. The arms were
positioned on the sides of the body and the hands were positioned
on the anterior edge of the chair. Tissue compliance (hardness) was
measured 22 cm above the right superior border patella at the thigh
center line using the ACP Tissue Compliance Meter. EMG pads were
positioned on the right quadricepts femoris muscle. One electrode
was positioned 9 cm above the right superior border paella, and the
other electrode was positioned a center of the thigh line between 9
to 17 cm above the right superior patella with the ground in the
center.
[0331] Six tests were performed on each subject. For the first
test, the subject's knee was flexed at a 60 degree angle with no
load. The EMG was measured for 10 seconds, and the tissue
compliance (hardness) was measured three times during the
ten-second interval.
[0332] For the remaining five tests, the subject's knee was flexed
at a 60 degree angle and a motorized dynamometer was used to apply
a load of 10, 20, 30, 40, and 60 pounds. The EMG was measured when
the applied load was reached during each contraction for a period
of 10 seconds while the contraction was maintained The tissue
compliance (hardness) was measured three times during the
ten-second interval while the EMG was being measured.
[0333] As shown in FIG. 4, the tissue compliance (hardness, lbs)
was plotted as a function of I-EMG. (mV) Increasing I-EMG resulted
in increasing tissue hardness (tissue compliance). Thus, this
figure shows that muscle contraction can be indirectly measured by
the I-EMG of the subject.
[0334] As shown in FIG. 5, the tissue compliance (hardness, lbs)
was plotted as a function of FFT (median Hz). Increasing tissue
compliance resulted in increasing FFT. Thus, this figure shows that
muscle contraction can be indirectly measured by the shift in the
median FFT frequency of the subject.
[0335] As shown in FIG. 6, FFT (median Hz) was plotted as a
function of I-EMG (mV)
[0336] The FFT increased with increasing I-EMG. This indicates that
FTT and I-EMG are related to each other and the muscle hardness
(tissue compliance).
Example 2
Joint Study
[0337] In this example, neuromuscular electrical stimulation having
a triphasic pulse train pattern was applied to the knee joint over
a 24-week period to five patients. All of the paitents exhibited
evidence of osteoarthritis (radiographic and/or by patient symptoms
report) in more than one joint; however, osteoarthritis of one knee
has been the patient's primary complaint and the focus of
treatment. The patients also exhibited a Kellgren and Lawrence
osteoarthritis classification grade 1, 2 or 3 (i.e., indicative of
cartilage still remaining in joint). The patients had also not
undergone within 3 months of enrollment, corticosteroid or
viscosupplementation (i.e., hyaluronate) injections to the effected
knee. Further, the patient had not been on a stable dose for at
least 3 months prior to enrollment of oral steroids, non-steroidal
anti-inflammatories, or acetaminophen. If taking chondroprotective
supplements (e.g., glucosamine and chondroitin sulfate), patient
had not been on a stable dose for at least 3 months prior of
enrollment. Table 1 summarizes the patient population:
TABLE-US-00001 TABLE 1 Patient Summary No. Side Age KL (PF) KL (FT)
Extension Flexion case 1 Lt 73 3 2 -10 115 case 2 Lt 73 3 2 -20 135
case 3 Rt 73 3 2 -5 135 case 4 Lt 62 2 2 0 140 case 5 Lt 62 1 2 -5
140 Patterned Neuromuscular Simulation for 20 min 3 times/week
.times. 12 weeks
[0338] Each patient received a 20-minute session, to each affected
knee, three times per week for 12 weeks. The neuromuscular
electrical stimulation comprised a tri-phasic lower extremity
stimulation pattern based on activation timing of the quadriceps
and hamstrings for strength training. More specifically, the
patient received 50 Hz impulses for 200 ms every 1500 ms) to
establish a minimal twitch for 5 minutes and a moderate to strong,
but well-tolerated twitch contractions for 15 minutes. The overlap
period was 40 ms. The electrodes were placed on the patient as
generally shown in FIG. 3P. The first pair of electrodes are
positioned on the patient's skin on the vastus medialis and upper
quadricep, and the second pair is positioned on the hamstring and
triceps Surae muscles. Even though the exact mechanism of action
for potential improvement of knee osteoarthritis and joint
compression is not fully understood, it is hypothesized that when
stimulating the muscles in this region that there may be an effect
on changing the circulation of the synovial fluid, an effect on
reducing disuse atrophy of the quadriceps and hamstrings, and an
improvement in motor timing. The maximum peak output of the device
is 10 mA into a 500 ohm load. The average current is very low
because the pulse duration is only 70 microseconds at a pulse rate
of 50 Hz. The average current would be approximately 4.5 mA average
current into a 500 ohm load. The typical outputs used in
stimulation varied from approximately 30-70 mA peak current or 1-3
mA average current.
[0339] FIG. 7A shows the Visual Analog Scores of the five patients
over the treatment period on a 0 to 100 mm scale. In general, the
patients' pain level increased (FIG. 7A), while their overall
condition improved (FIG. 7B). The scale was be anchored at one end
with "0" and labeled "no pain at all," and at the other "10" and
labeled "worst pain possible." FIG. 8 illustrates the results of
the Western Ontario MacMaster 3.1 (WOMAC), a 24-item validated test
designed specifically for the assessment of lower extremity pain,
stiffness, and physical function disability in osteoarthritis of
the knee. WOMAC scores were very much higher (abnormal) prior to
undergoing treatment.
[0340] FIGS. 9 and 10 show the muscle strength of each patient
throughout the course of treatment for the quadriceps, and
hamstrings respectively. The strength of patients 1 and 2 was
measured in Newtons, while that of patients 3, 4, and 5 was
measured in kilograms. In general, the muscle strength improved
over the course of treatment. The muscle strength was measured
using a mechanical dynamometer.
[0341] The immediate effect of a 20-minute treatment was also
evaluated using a physical performance test. Patients were asked to
stand up 10 times as fast as possible. FIG. 11A that the patient's
VAS pain level decreased after most treatment sessions. Further, as
shown in FIG. 11B, the amount of time it took to complete the test
either decreased or was not changed as a result of the treatment
session. As shown in FIG. 11C, over the entire 24-week treatment
course, the amount of time it took it took to complete the test
generally decreased.
[0342] The amount of fluid in the affected knee of each patient was
also measured in order to assess the degree of inflammation in the
joint. As shown in Table 2, in four of the five patients, the
amount of fluid in the joint decreased by amount 2 ml. Thus, this
indicates that the neuromuscular electrical stimulation was
effective in decreasing inflammation.
TABLE-US-00002 TABLE 2 Joint Fluid Joint Fluid Post 12 Joint Fluid
weeks of No. Pre ml treatment Case 1 2 0 Case 2 12 10 Case 3 0 N/A
Case 4 2 0 Case 5 7 10
[0343] Lastly, delayed gadolinium-enhanced magnetic resonance
imaging ("MRI") of cartilage ("dGEMRIC") was used in order to is
used to examine the distribution of glycosaminoglycan in cartilage
as generally described in Williams et al., Delayed
gadolinium-enhanced magnetic resonance imaging of cartilage in knee
osteoarthritis: findings at different radiographic stages of
disease and relationship to malalignment, Arthritis Rheum. 2005
November; 52(11):3528-35, which is incorporated by reference.
Glycosaminoglycans provide cartilage its compressive strength and
the dGEMRIC technique uses a negatively charged MR contrast agent
to determine the GAG distribution within the cartilage. Table 3
below shows that the relative intensity of the tibia and femur
generally decreased. A negative pre-post reading indicates
increased markers for cartilage.
TABLE-US-00003 TABLE 3 Relative intensity Tibia Femur Pre Post Pre
Post Case 1 67.2 62.2 -7.44% 76.4 72.8 -4.71% Case 2 60.7 64.5
6.26% 73.4 72.5 -1.22% Case 3 80.9 73.5 -9.15% 73.3 84.2 14.9% Case
4 72.3 56.1 -22.4% 85.8 86.8 1.17% Case 5 109 100 -8.26% 88.4 98
10.9%
[0344] Together, these experiments indicate that joint compression
decreased after applying the patterned neuromuscular electrical
stimulation to the affected joint.
[0345] While specific embodiments have been shown and discussed,
various modifications may of course be made, and the invention is
not limited to the specific forms or arrangement of parts and steps
described herein, except insofar as such limitations are included
in the following claims. Further, it will be understood that
certain features and subcombinations are of utility and may be
employed without reference to other features and subcombinations.
This is contemplated by and is within the scope of the claims.
* * * * *