electrical stimulation for the treatment of pain & muscle rehabilitation

Transcription

ELECTRICAL STIMULATION FOR THE
TREATMENT OF PAIN & MUSCLE REHABILITATION
Protocol: DME013
Effective Date: February 1, 2015
Table of Contents
Page
COMMERCIAL COVERAGE RATIONALE......................................................................................... 1 MEDICARE & MEDICAID COVERAGE RATIONALE ...................................................................... 3 DESCRIPTION OF SERVICES .............................................................................................................. 7 CLINICAL EVIDENCE ........................................................................................................................... 8 U.S. FOOD AND DRUG ADMINISTRATION (FDA) ........................................................................ 17 APPLICABLE CODES .......................................................................................................................... 19 REFERENCES ....................................................................................................................................... 21 PROTOCOL HISTORY/REVISION INFORMATION ........................................................................ 24 INSTRUCTIONS FOR USE
This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding
coverage, the enrollee specific document must be referenced. The terms of an enrollee's document
(e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event
of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first
identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage
prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may
apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and
Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute
medical advice.
UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines,
to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in
connection with the independent professional medical judgment of a qualified health care provider and
do not constitute the practice of medicine or medical advice.
COMMERCIAL COVERAGE RATIONALE
Functional electrical stimulation (FES), a form of neuromuscular electrical stimulation (such as
Parastep I), is medically necessary for rehabilitation in persons with paralyzed lower limbs due to
spinal cord injury (SCI) with all of the following characteristics:
 Intact lower motor units (L1 and below) (both muscle and peripheral nerves)
 Muscle and joint stability for weight bearing at upper and lower extremities that can demonstrate
balance and control to maintain an upright support posture independently;
Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation
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Demonstrate brisk muscle contraction to NMES and have sensory perception of electrical
stimulation sufficient for muscle contraction;
Possess high motivation, commitment and cognitive ability to use such devices for walking;
Able to transfer independently and demonstrate independent standing tolerance for at least 3
minutes;
Demonstrate hand and finger function to manipulate controls;
Post recovery from spinal cord injury and restorative surgery of at least 6-months;
No hip and knee degenerative disease and no history of long bone fracture secondary to
osteoporosis
Functional electrical stimulation is not medically necessary for the treatment of disuse muscle
atrophy in persons with spinal cord injury (who do not meet the requirements above) or multiple
sclerosis. Further studies are needed to confirm that functional electrical stimulation promotes bone
remineralization and prevents or reverses muscle atrophy. Only a few studies have looked at FES as a
modality of treatment of multiple sclerosis, and the results are limited and conflicting regarding
whether FES improves treatment outcomes in multiple sclerosis when offered in addition to other
rehabilitative treatment modalities.
Functional electrical stimulation is not medically necessary for the treatment of gait disorders (e.g.,
foot drop) of central neurologic origin including but not limited to stroke or multiple sclerosis. There is
insufficient evidence in the peer reviewed literature that use of functional electrical stimulation will
improve health outcomes in patients with gait disorders. Published studies have included small
heterogeneous patient populations, short-term follow-ups, and various treatment protocols, outcome
measures, and FES devices. Only a few studies have looked at FES as a modality of treatment of
multiple sclerosis, and the results are limited and conflicting regarding whether FES improves
treatment outcomes in multiple sclerosis when offered in addition to other rehabilitative treatment
modalities.
Neuromuscular electrical stimulation (NMES) is medically necessary for:
A. Treatment of disuse muscle atrophy if:
 the nerve supply to the muscle is intact; and
 the disuse muscle atrophy is not of neurological origin but originates from conditions such as
casting, splinting or contractures.
B. Treatment to improve wrist and finger function and prevent or correct shoulder subluxation in
persons with partial paralysis following stroke
Neuromuscular electrical stimulation (NMES) is not medically necessary for the treatment of
neurologic, orthopedic (e.g., scoliosis) or other abnormalities including pain not listed as medically
necessary. Additionally, there is insufficient evidence for NMES for all other indications. There is
insufficient evidence in the peer reviewed literature that use of electrical stimulation will improve
health outcomes for the treatment of neurologic or orthopedic conditions other than those identified
above as medically necessary. Randomized, controlled trials are necessary to assess the durability of
this procedure in comparison to other types of treatment.
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Interferential therapy (IFT) is not medically necessary for the treatment of pain associated with
musculoskeletal disorders or injuries, and stimulating healing of nonsurgical soft tissue injuries.
Interferential therapy is not medically necessary to facilitate the healing of bone fractures.
There is insufficient evidence from the available studies to conclude that interferential therapy
promotes healing of bone fractures. None of the double-blind, randomized, placebo-controlled studies
reported a positive treatment effect of interferential therapy for bone fractures.
Pulsed electrical stimulation (PES) is not medically necessary for the treatment of osteoarthritis.
There is insufficient evidence to conclude that PES provides health benefits to patients with
osteoarthritis. Randomized, controlled trials are necessary to assess the durability of this procedure in
comparison to other types of treatment.
Peripheral subcutaneous field stimulation (PSFS) or peripheral nerve field stimulation (PNFS) is
not medically necessary for the treatment of pain. Evidence for the effectiveness of PSFS or PNFS
based on controlled studies is lacking. Randomized controlled trials are needed to evaluate the efficacy
of this treatment.
MEDICARE & MEDICAID COVERAGE RATIONALE
Medicare has a National Coverage Determination for Electrical Nerve Stimulators (160.7),
accessed December 2014. The National Coverage Determination is as follows:
Indications and Limitations of Coverage
Two general classifications of electrical nerve stimulators are employed to treat chronic intractable
pain: peripheral nerve stimulators and central nervous system stimulators.
A - Implanted Peripheral Nerve Stimulators
Payment may be made under the prosthetic device benefit for implanted peripheral nerve stimulators.
Use of this stimulator involves implantation of electrodes around a selected peripheral nerve. The
stimulating electrode is connected by an insulated lead to a receiver unit which is implanted under the
skin at a depth not greater than 1/2 inch.
Stimulation is induced by a generator connected to an antenna unit which is attached to the skin
surface over the receiver unit. Implantation of electrodes requires surgery and usually necessitates an
operating room.
Note: Peripheral nerve stimulators may also be employed to assess a patient's suitability for continued
treatment with an electric nerve stimulator. As explained in §160.7.1, such use of the stimulator is
covered as part of the total diagnostic service furnished to the beneficiary rather than as a prosthesis.
B - Central Nervous System Stimulators (Dorsal Column and Depth Brain Stimulators)
The implantation of central nervous system stimulators may be covered as therapies for the relief of
chronic intractable pain, subject to the following conditions:
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1 - Types of Implantations
There are two types of implantations covered by this instruction:
 Dorsal Column (Spinal Cord) Neurostimulation - The surgical implantation of neurostimulator
electrodes within the dura mater (endodural) or the percutaneous insertion of electrodes in the
epidural space is covered.
 Depth Brain Neurostimulation - The stereotactic implantation of electrodes in the deep brain
(e.g., thalamus and periaqueductal gray matter) is covered.
2 - Conditions for Coverage
No payment may be made for the implantation of dorsal column or depth brain stimulators or services
and supplies related to such implantation, unless all of the conditions listed below have been met:
 The implantation of the stimulator is used only as a late resort (if not a last resort) for patients
with chronic intractable pain;
 With respect to item a, other treatment modalities (pharmacological, surgical, physical, or
psychological therapies) have been tried and did not prove satisfactory, or are judged to be
unsuitable or contraindicated for the given patient;
 Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary
team prior to implantation. (Such screening must include psychological, as well as physical
evaluation);
 All the facilities, equipment, and professional and support personnel required for the proper
diagnosis, treatment training, and followup of the patient (including that required to satisfy item
c) must be available; and
 Demonstration of pain relief with a temporarily implanted electrode precedes permanent
implantation.
Contractors may find it helpful to work with QIOs to obtain the information needed to apply these
conditions to claims.
Medicare has a National Coverage Determination for Neuromuscular Electrical Stimulation
(NMES) (160.12), accessed December 2014 and it is as follows:
Treatment of Muscle Atrophy
Coverage of NMES to treat muscle atrophy is limited to the treatment of disuse atrophy where nerve
supply to the muscle is intact, including brain, spinal cord and peripheral nerves, and other nonneurological reasons for disuse atrophy. Some examples would be casting or splinting of a limb,
contracture due to scarring of soft tissue as in burn lesions, and hip replacement surgery (until orthotic
training begins).
Use for Walking in Patients with Spinal Cord Injury (SCI)
The type of NMES that is use to enhance the ability to walk of SCI patients is commonly referred to as
functional electrical stimulation (FES). These devices are surface units that use electrical impulses to
activate paralyzed or weak muscles in precise sequence. Coverage for the use of NMES/FES is limited
to SCI patients for walking, who have completed a training program which consists of at least 32
physical therapy sessions with the device over a period of three months. The trial period of physical
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therapy will enable the physician treating the patient for his or her spinal cord injury to properly
evaluate the person's ability to use these devices frequently and for the long term. Physical therapy
necessary to perform this training must be directly performed by the physical therapist as part of a oneon-one training program.
The goal of physical therapy must be to train SCI patients on the use of NMES/FES devices to achieve
walking, not to reverse or retard muscle atrophy.
Coverage for NMES/FES for walking will be covered in SCI patients with all of the following
characteristics:
1. Persons with intact lower motor units (L1 and below) (both muscle and peripheral nerve);
2. Persons with muscle and joint stability for weight bearing at upper and lower extremities that
can demonstrate balance and control to maintain an upright support posture independently;
3. Persons that demonstrate brisk muscle contraction to NMES and have sensory perception
electrical stimulation sufficient for muscle contraction;
4. Persons that possess high motivation, commitment and cognitive ability to use such devices for
walking;
5. Persons that can transfer independently and can demonstrate independent standing tolerance for
at least 3 minutes;
6. Persons that can demonstrate hand and finger function to manipulate controls;
7. Persons with at least 6-month post recovery spinal cord injury and restorative surgery;
8. Persons without hip and knee degenerative disease and no history of long bone fracture
secondary to osteoporosis; and
9. Persons who have demonstrated a willingness to use the device long-term.
NMES/FES for walking will not be covered in SCI patient with any of the following:
1. Persons with cardiac pacemakers;
2. Severe scoliosis or severe osteoporosis;
3. Skin disease or cancer at area of stimulation;
4. Irreversible contracture; or
5. Autonomic dysflexia.
The only settings where therapists with the sufficient skills to provide these services are employed, are
inpatient hospitals; outpatient hospitals; comprehensive outpatient rehabilitation facilities; and
outpatient rehabilitation facilities. The physical therapy necessary to perform this training must be part
of a one-on-one training program.
Medicare has a National Coverage Determination for Supplies Used in the Delivery of
Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stimulation
(NMES) (160.13). There is no Local Coverage Determination as this time (accessed December 2014).
The National Coverage Determination is as follows:
TENS and/or NMES can ordinarily be delivered to patients through the use of conventional electrodes,
adhesive tapes and lead wires. There may be times, however, where it might be medically necessary
for certain patients receiving TENS or NMES treatment to use, as an alternative to conventional
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electrodes, adhesive tapes and lead wires, a form-fitting conductive garment (i.e., a garment with
conductive fibers which are separated from the patients' skin by layers of fabric).
A form-fitting conductive garment (and medically necessary related supplies) may be covered under
the program only when:
1. It has received permission or approval for marketing by the Food and Drug Administration;
2. It has been prescribed by a physician for use in delivering covered TENS or NMES treatment;
and
3. One of the medical indications outlined below is met:
 The patient cannot manage without the conductive garment because there is such a large
area or so many sites to be stimulated and the stimulation would have to be delivered so
frequently that it is not feasible to use conventional electrodes, adhesive tapes and lead
wires;
 The patient cannot manage without the conductive garment for the treatment of chronic
intractable pain because the areas or sites to be stimulated are inaccessible with the use of
conventional electrodes, adhesive tapes and lead wires;
 The patient has a documented medical condition such as skin problems that preclude the
application of conventional electrodes, adhesive tapes and lead wires;
 The patient requires electrical stimulation beneath a cast either to treat disuse atrophy,
where the nerve supply to the muscle is intact, or to treat chronic intractable pain; or
 The patient has a medical need for rehabilitation strengthening (pursuant to a written plan
of rehabilitation) following an injury where the nerve supply to the muscle is intact.
A conductive garment is not covered for use with a TENS device during the trial period specified in
§160.3 unless:
1. The patient has a documented skin problem prior to the start of the trial period; and
2. The carrier's medical consultants are satisfied that use of such an item is medically necessary
for the patient.
There is a Local Coverage Determination for Nevada for Physical Medicine and Rehabilitation
Policy which includes information regarding Interferential Therapy (L28290), accessed December
2014. The Local Coverage Determination is as follows:
97032 Application of a modality to one or more areas; electrical stimulation (manual), each 15 minutes
This modality includes the following types of electrical stimulation (when provided under constant
attendance):
 Transcutaneous electrical nerve stimulation (TENS) is used primarily for pain control. No more
than a single office session will be allowed for the purpose of training for in-home use.
 Neuromuscular stimulation: Used for retraining weak muscles following surgery or injury.
 Muscle stimulation: This type of stimulation is taken to the point of visible muscle contraction.
 High voltage pulsed current, also called electrogalvanic stimulation, may be useful for reducing
swelling and for control of pain.
 Interferential current/medium current: These units use a frequency that allows the current to go;
deeper. IFC is used to control swelling and pain.
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These uses may be necessary during the initial phase of treatment, but there must be an
expectation of improvement in function, and must be utilized with appropriate therapeutic
procedures (e.g., 97110) to effect continued improvement.
Electrical stimulation is typically used in conjunction with therapeutic exercises. A limited
number of visits without a therapeutic procedure may be medically necessary for treatment of
muscle spasm and swelling.
Treatment would not be expected to exceed 4 treatments per week, for no longer than one
month when used as adjunctive therapy or for muscle retraining.
When electrical stimulation is used for muscle strengthening or retraining, the nerve supply to
the muscle must be intact. It is not medically necessary for motor nerve disorders such as Bell’s
Palsy. It is not medically necessary when there is limited potential for restoration of function.
For Medicare and Medicaid Determinations Related to States Outside of Nevada:
Please review Local Coverage Determinations that apply to other states outside of Nevada.
http://www.cms.hhs.gov/mcd/search
Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage
database on the Centers for Medicare and Medicaid Services’ Website.
DESCRIPTION OF SERVICES
Electrical stimulators provide direct, alternating, pulsating and/or pulsed waveform forms of energy.
The devices are used to exercise muscles, demonstrate a muscular response to stimulation of a nerve,
relieve pain, relieve incontinence, and provide test measurements. Electrical stimulators may have
controls for setting the pulse length, pulse repetition frequency, pulse amplitude, and triggering modes.
Electrodes for such devices may be indwelling, transcutaneous implanted or surface.
Functional electrical stimulation (FES), or therapeutic electrical stimulation (TES), attempts to
prevent or reverse muscular atrophy and bone demineralization by stimulating paralyzed lower limbs
to perform stationary exercise or standing and walking. Functional electrical stimulation has also been
investigated as a way to improve gait disorders of hemiplegic patients. Although some paraplegics can
walk extended distances using a functional electrical stimulator, this technology is not intended as a
replacement for a wheelchair. (Hayes, 2003)
It is designed to be used as part of a self-administered home-based rehabilitation program for the
treatment of upper limb paralysis from hemiplegic stroke, traumatic brain injury or C5 to C6 spinal
cord injury. The system contains a custom-fitted orthosis and a control unit. The control unit allows the
user to adjust the stimulation intensity and training mode. Exercise sessions can be gradually increased
to avoid muscle over-fatigue.
Parastep I is an electrical stimulation device for paraplegics. ERGYS is a powered muscle stimulator
and RT300 is a FES cycle ergometer for relaxation of muscle spasms and prevention or retardation of
disuse atrophy. Walkaide is a neuromuscular functional stimulator that stimulates the muscles that
cause ankle dorsiflexion. NESS L300 provides ankle dorsiflexion in individuals with drop foot
following an upper motor neuron injury or disease.
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Interferential therapy (IFT) is a type of transcutaneous electrotherapy. Two slightly different,
medium frequency alternating currents are simultaneously applied to the affected area through
electrodes. Superposition or interference between the two currents causes the combined electrical
current to rise and fall.
Neuromuscular electrical stimulation (NMES) involves the use of transcutaneous application of
electrical currents to cause muscle contractions. The goal of NMES is to promote reinnervation, to
prevent or retard disuse atrophy, to relax muscle spasms, and to promote voluntary control of muscles
in patients who have lost muscle function due to surgery, neurological injury, or disabling condition.
(Hayes, 2008)
Neuromuscular electrical stimulators (NMES) are divided into two broad categories:
Therapeutic and Functional.
Therapeutic electrical stimulation strengthens muscles weakened by disuse while functional
electrical stimulation attempts to replace destroyed nerve pathways by electrical stimulation to
the muscle in order to assist a functional movement.
Functional NMES is a method being developed to restore function to patients with
damaged or destroyed nerve pathways through use of an orthotic device with microprocessor
controlled electrical neuromuscular stimulation
Pulsed electrical stimulation (PES) is hypothesized to facilitate bone formation, cartilage repair, and
alter inflammatory cell function. Some chondrocyte and osteoblast functions are mediated by electrical
fields induced in the extracellular matrix by mechanical stresses. Electrostatic and electrodynamic
fields may also alter cyclic adenosine monophosphate or DNA synthesis in cartilage and bone cells.
Peripheral subcutaneous field stimulation (PSFS), also known as peripheral nerve field stimulation
(PNFS), is a technique used when the field to be stimulated is not well defined by any one or two
peripheral nerves. PSFS is not the same as spinal cord stimulation (SCS) or peripheral nerve
stimulation (PNS). During PSFS, a stimulator device (i.e., electrode arrays) is implanted within the
subcutaneous tissue over the painful area, not on or around identified neural structures (Abejon and
Krames 2009).
CLINICAL EVIDENCE
Functional electrical stimulation (FES)
Hayes (2011) performed evidence review from six studies that evaluated FES for treatment of patients
with multiple sclerosis. Some evidence from six clinical studies that were evaluated suggests that use
of the WalkAide System or the ODFS Pace may improve walking speed; however, the results were
conflicting. Some studies reported significant increases in walking speed with FES ranging from 7% to
14% compared with baseline, while others reported no significant clinical effect or increases in
walking speeds. There was no evidence suggesting that the use of the FES device helped MS patient’s
approximate normal walking speed. Overall, there was very limited evidence on the effect of FES on
other patient-relevant, functional measures. For example, none of the studies evaluated whether FES
enabled patients to walk up and down stairs, walk on uneven ground, perform side steps, or whether its
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use improved confidence while performing these various activities. The bulk of the evidence evaluated
surrogate outcome measures, including gait and walking parameters, measured in highly controlled
experimental settings, to predict functional status in everyday environments. Such results may not be
of immediate clinical relevance to the patient, or may not translate directly to functional improvement
in ADL or improvement in QOL. There was no available evidence regarding implantable FES devices.
Since the studies were case series and poor-quality RCTs, the validity of the evidence is unclear. It was
difficult to compare the study findings due to various limitations, such as considerable clinical and
methodological heterogeneity across the available studies, the insufficient power of these small clinical
trials to detect statistical differences between treatment groups, and the lack of blinding and placebo
groups (although blinding and the use of adequate placebo groups were not always practical or
feasible). In addition, few of the available studies discussed the magnitude of benefit of FES treatment
or whether the therapy leads to meaningful improvements in health outcomes for patients with MS.
Future, well-designed, sufficiently powered RCTs with adequate follow-up are necessary to compare
the use of FES with appropriate placebo controls, such as sham treatments, and establish the magnitude
of benefit of FES devices. Future research should compare different applications of FES, including
implanted or surface stimulation. Methods of independent assessment should be incorporated since
adequate blinding is not always feasible for this technology. Additional well-designed studies are
necessary to adequately assess the impact of FES on functional status with a particular emphasis on
practical dimensions of ADL. Studies with a priori plans for subgroup analyses are also needed to
determine the patient and disease characteristics that are associated with clinically relevant, successful
outcomes.
A randomized, controlled trial examined coordination exercises, gait training, and treadmill training
with and without FES using intramuscular electrodes in 32 patients after stroke (Daly, 2006). The
group treated with FES using intramuscular electrodes demonstrated statistically significant greater
gains for gait component execution and knee flexion coordination than the control group. A trial of 43
subjects, who had undergone anterior cruciate ligament reconstruction were randomly assigned to
receive or not receive FES as an adjunct treatment to improve quadriceps strength. The FES group
demonstrated greater quadriceps strength at 12 weeks and higher levels of self-reported knee function
at 12 and 16 weeks as compared to the group that did not receive FES (Fitzgerald, 2003).
Barrett et al. (2009) conducted a two-group randomized trial to assess the effects of single channel
common peroneal nerve stimulation on objective aspects of gait relative to exercise therapy for people
with chronic progressive multiple sclerosis (CPMS). Forty-four people with a diagnosis of CPMS and
unilateral dropped foot completed the trial. Patients were randomly allocated to receive either FES
(n=20) or a physiotherapy home exercise program (n=24) for 18 weeks. The exercise group showed a
statistically significant increase in 10 m walking speed and distance walked in 3 min, relative to the
FES group who showed no significant change in walking performance without stimulation. At each
stage of the trial, the FES group performed to a significantly higher level with FES than without for the
same outcome measures. The authors concluded that exercise may provide a greater training effect on
walking speed and endurance than FES for people with CPMS. Additional studies are needed to
investigate the combined therapeutic effects of FES and exercise for patients with MS.
Broekmans et al. (2011) conducted a randomized controlled study involving 36 persons with multiple
sclerosis (MS) to examine the effect(s) of unilateral long-term (20 weeks) standardized resistance
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training with and without simultaneous electro-stimulation on leg muscle strength and overall
functional mobility. The authors found, that long-term light to moderately intense resistance training
improves muscle strength in persons with MS but simultaneous electrostimulation does not further
improve training outcome.
A clinical trial by Kesar et al. (2009) evaluated the effects of delivering FES to both ankle
plantarflexors and dorsiflexors to improve gait in 13 post-stroke patients. The authors found that
delivering FES to both the plantarflexor and dorsiflexor muscles can help to correct post-stroke gait
deficits at multiple joints (ankle and knee) during both the swing and stance phases of gait. However,
this is a very small uncontrolled study.
A pilot study by Ratchford et al. (2010) evaluated the safety and preliminary efficacy of home FES
cycling in 5 patients with chronic progressive multiple sclerosis (CPMS) to explore how it changes
cerebrospinal fluid (CSF) cytokine levels. Outcomes were measured by: Two Minute Walk Test,
Timed 25-foot Walk, Timed Up and Go Test, leg strength, Expanded Disability Status Scale (EDSS)
score, and Multiple Sclerosis Functional Composite (MSFC) score. Quality-of-life was measured using
the Short-Form 36 (SF-36). Cytokines and growth factors were measured in the CSF before and after
FES cycling. Improvements were seen in the Two Minute Walk Test, Timed 25-foot Walk, and Timed
Up and Go tests. Strength improved in muscles stimulated by the FES cycle, but not in other muscles.
No change was seen in the EDSS score, but the MSFC score improved. The physical and mental health
subscores and the total SF-36 score improved. The authors concluded that FES cycling was reasonably
well tolerated by chronic progressive MS patients and encouraging improvements were seen in
walking and quality-of-life. The study is limited by small sample. Larger studies are needed to evaluate
the effects of FES for patients with MS.
The National Institute for Health and Clinical Excellence (NICE) published a guidance document in
2009 for the use of FES for foot drop of central neurological origin. NICE concluded that the evidence
on safety and efficacy appears adequate to support the use of FES for foot drop in terms of improving
gait, but further publication on the efficacy of FES would be useful regarding patient-reported
outcomes, such as quality of life and activities of daily living.
Preliminary evidence indicates that paraplegics can benefit from functional electrical stimulation that
exercises muscles without providing locomotion. In one study, electrically stimulated isometric
exercise reversed bone demineralization and increased muscle strength (Belanger, 2000). In a second
study, electrically stimulated use of an exercise cycle by paraplegics restored muscle mass (Baldi,
1998). In another study, bone mineral density improved in some bones of patients with spinal cord
injury (SCI) after use of the FES bicycle (Chen, 2005).
Certain studies report results with more sophisticated functional stimulators that allow some
paraplegics to stand and walk. Most of the subjects enrolled in these studies succeeded in standing and
walking and, using their baseline state as a control, they experienced many benefits including positive
psychological changes, improved cardiovascular fitness, and increased muscle strength, muscle mass,
and lower limb blood flow. However, achieving these benefits exposed the patients to significant risks
(Hayes, 2003).
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Despite these increased risks, the benefits of electrically stimulated ambulation do not appear to exceed
those of electrically stimulated isometric or cycling exercise. While most studies involved patients with
many years of muscular atrophy, Baldi et al. (1998) utilized patients with less than 4 months of
atrophy. Moreover, electrically stimulated isometric exercise stimulated bone remineralization that was
not observed with electrically stimulated walking (Needham-Shropshire, 1997; Belanger, 2000). The
ambulation provided by functional electrical stimulation may also appear to provide an advantage over
devices that only provide paraplegics with exercise but the speed and range of electrically stimulated
ambulation are so limited that researchers evaluating the Parastep system concluded that it could not
replace the wheelchair (Hayes, 2003). Even if the ambulation provided by devices such as the Parastep
significantly improves, it will still only be usable by a subset of paraplegic patients such as those with
T4-T11 spinal cord injuries (Klose, 1997). Stationary electrically stimulated exercise can be performed
by a much larger group of patients including quadraplegics. To summarize, electrically stimulated
ambulation cannot be considered safer or more beneficial than electrically stimulated stationary
exercise unless the benefits of ambulation are shown to be superior in large-scale trials in which
paraplegic patients are randomized to these two therapies. Further studies also need to be performed to
confirm the benefits of electrically stimulated stationary exercise since the controlled trials conducted
to date have used very small study populations and have assessed a limited set of outcome measures
(Baldi, 1998; Belanger, 2000).
In a small-scale study, functional electrical stimulation significantly improved walking speed of
patients with cerebral or spinal cord injuries that caused partial lower limb paralysis (Wieler, 1999). It
is anticipated that large, randomized controlled trials would confirm these preliminary results and
establish functional electrical stimulation as a standard therapy for patients with correctable gait
disorders.
Neuromuscular electrical stimulation (NMES) for muscle rehabilitation
There is evidence from several randomized, controlled trials that NMES can improve wrist and finger
function and prevent or correct shoulder subluxation in some patients with partial paralysis due to
stroke. NMES is a well-established treatment modality for disuse atrophy when the nerve supply to the
muscle is intact.
Hsu et al. (2010) conducted a randomized controlled trial to investigate the effects of different doses of
neuromuscular electrical stimulation (NMES) on upper-extremity function in acute stroke patients with
severe motor deficit. Sixty-six acute stroke patients were equally randomized to 3 groups: high NMES,
low NMES, or control. The treatment groups received NMES 5 days per week with the high-NMES
group receiving 60 minutes of stimulation per day, and low-NMES group receiving 30 minutes per day
for 4 weeks. The Fugl-Meyer Motor Assessment Scale, Action Research Arm Test, and Motor Activity
Log were used to assess the patients at baseline, 4 and 12 weeks. Twelve subjects were lost to followup because of transportation difficulties (n=10) and relocation (n=2). Both NMES groups showed
significant improvement on Fugl-Meyer Motor Assessment and Action Research Arm Test scales
compared with the control group at week 4 and week 12. The high-NMES group showed treatment
effects similar to those of the low-NMES group. The authors concluded that both higher and lower
doses of NMES led to similar improvements in motor function.
In a randomized, controlled study by Ring and Rosenthal (2005), 22 patients with moderate to severe
upper limb paresis 3-6 months post-onset were evaluated to assess the effects of daily neuroprosthetic
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(NESS Handmaster) functional electrical stimulation in sub-acute stroke. Patients were stratified into 2
groups: no active finger movement and partial active finger movements, and then randomized to
control and neuroprosthesis groups. The neuroprosthesis group had significantly greater improvements
in spasticity, active range of motion and scores on the functional hand tests (those with partial active
motion). Of the few patients with pain and edema, there was improvement only among those in the
neuroprosthesis group. There were no adverse reactions. The authors concluded that supplementing
standard outpatient rehabilitation with daily home neuroprosthetic activation improve upper limb
outcomes.
There are also studies that NMES can be effective when used for quadriceps strength training
following ACL reconstruction or prior to total knee arthroplasty. In a small randomized controlled trial
of NMES for quadriceps strength training following ACL reconstruction, the group that received
NMES demonstrated moderately greater quadriceps strength at 12 weeks and moderately higher levels
of knee function at both 12 and 16 weeks of rehabilitation compared to the control group (Fitzgerald,
2003). Another small study by Walls et al. (2010) evaluated the effects of preoperative NMES for 9
patients undergoing total knee arthroplasty. Five patients served as a control group. Preoperative
quadriceps muscle strength increased by 28% in the NMES group. Early postoperative strength loss
was similar in both groups; however the NMES group had a faster recovery with greater strength over
the control group at 12 weeks postoperatively.
In a 2008 systematic review of anterior cruciate ligament reconstruction (ACL) rehabilitation. Wright
et al. reported that 14 randomized controlled trials had evaluated postoperative NMES following ACL
reconstructionStudy limitations included the following: poor study design; heterogeneous patient
populations; and lack of independent observers. The authors noted that it was difficult to make
generalized conclusions regarding NMES for this indication.
Cauraugh and Kim (2003) examined NMES for the assistance of stroke motor recovery in a RCT of 34
stroke patients. The mixed design analyses on three categories of behavioral measures demonstrated
motor improvements in the treatment group.
In 2010, Weber and colleagues reported on the use of the Bioness H200 device for use as a supplement
to treatment with onabotulinumtoxinA and occupational therapy among 23 stroke patients with
spasticity after stroke.[12] The primary outcome was progression in upper limb motor function, as
measured by improvement in the Motor Activity Log instrument after 12 weeks of therapy. Although
improvements in motor activity were seen among all patients after 6 and 12 weeks, no additional
benefit was observed among patients treated with functional neuromuscular electrical stimulation
versus the comparison group, potentially due to small sample size. NMES has been used to treat a
variety of other conditions including strengthening leg muscles after hip fracture and spinal cord
injury, increasing wrist extension and reducing arm impairment after stroke, and providing exercise for
patients with severe physical limitations due to chronic obstructive pulmonary disease or heart disease.
Although RCTs that met the criteria for detailed review provided some evidence that NMES might
benefit some patients with these conditions, these trials were small and did not involve sufficient
follow-up to provide convincing evidence of the benefits of NMES treatment.
A detailed search of the medical peer-reviewed literature did not identify any clinical studies that
evaluated electrical stimulation for the treatment of scoliosis.
Page 12 of 24
A 2008 Hayes Directory Report on Neuromuscular Electrical Stimulation for Muscle Rehabilitation
states there is insufficient evidence for NMES for all other indications, including rehabilitating leg
muscles after anterior cruciate ligament surgery, strengthening leg muscles after hip fracture or hip
replacement surgery, strengthening muscles of the arm after spinal cord injury, improving motor
function in patients with cerebral palsy, and providing exercise for patients with severe physical
limitations due to chronic osteoarthritis, obstructive pulmonary disease or chronic heart failure.
Professional Societies/Organizations
The American Society of Anesthesiologists Task Force on Chronic Pain and the American Society of
Regional Anesthesia and Pain Medicine practice guidelines (2011) stated that NMES may be used as
part of a multimodal treatment of patients with painful peripheral nerve injuries unresponsive to other
therapies.
In the evaluation of the literature regarding electrical stimulation for the treatment of spasticity in
multiple sclerosis, the Multiple Sclerosis Council for Clinical Practice Guidelines (2005) stated that
“surface electrical stimulation may be of benefit in reducing spasticity in persons with MS, but there is
currently no evidence to support this supposition at this time.”
Interferential therapy (IFT)
IFT (Interferential therapy), is a treatment modality that is proposed to relieve musculoskeletal pain
and increase healing in soft tissue injuries and bone fractures. Two medium-frequency, pulsed currents
are delivered via electrodes placed on the skin over the targeted area producing a low-frequency
current. IFT delivers a crisscross current resulting in deeper muscle penetration. It is theorized that IFT
prompts the body to secrete endorphins and other natural painkillers and stimulates parasympathetic
nerve fibers to increase blood flow and reduce edema.
In 2010, Fuentes and colleagues published a systematic review and meta-analysis of studies evaluating
the effectiveness of interferential stimulation for treating pain. A total of 20 studies met the following
inclusion criteria: randomized controlled trial; included adults diagnosed with a painful
musculoskeletal condition; compared IFS (alone or as a co-intervention) to placebo, no treatment or an
alternative intervention; and assessed pain on a numeric scale. Fourteen of the trials reported data that
could be included in a pooled analysis. Interferential stimulation as a stand-alone intervention was not
found to be more effective than placebo or an alternative intervention.
A multi-center, randomized single-blind, controlled study by Burch et al. (2008) to investigate the
benefits of the combination of interferential (IF) and patterned muscle stimulation in the treatment of
osteoarthritis (OA) of the knee. The study randomized 116 patients with OA of the knee to a test or
control group. The devices used to deliver the electrical stimulation were pre-programmed to deliver
either IF plus patterned muscle stimulation (test group) or low-current TENS treatment (control group).
Both groups were treated for 8 weeks. Subjects completed questionnaires at baseline and after 2, 4 and
8 weeks. Primary outcomes included the pain and physical function subscales of the Western Ontario
MacMaster (WOMAC) OA Index and Visual Analog Scales (VAS) for pain and quality of life. The
mean changes from baseline to last visit in quality of life VAS rating were similar between the two
groups (18.17 vs. 18.16). Patients in the test group had a greater decrease in the overall pain VAS
(27.91 vs. 23.19; P=0.29) at their last visit, but the difference between treatment groups did not achieve
statistical significance. However, if only patients who completed the study (49 in test group and 50 in
Page 13 of 24
control group) were included for the analysis, the difference between groups in mean change from
baseline increased from 4.71 to 9.40 for overall pain VAS rating and achieved statistical significance
(P = 0.038). Although the study design was a randomized controlled trial of sufficient size, the study
was manufacturer sponsored, with intervening treatment variables, 10% drop out rate and the treatment
effect did not reach sufficient significant difference.
Jarit et al. (2003) conducted a randomized, double-blind, placebo-controlled trial of home-based,
interferential therapy in 87 patients who had undergone anterior cruciate ligament (ACL)
reconstruction, menisectomy, or knee chondroplasty. Patients were divided into 3 groups based on type
of knee surgery and within each group randomized into treatment and placebo group. All patients were
given home IFT devices. The treatment groups received working IFT units while the placebo groups
received units set to deliver no current. At baseline, there were no statistically significant differences
between IFT and control groups in edema or ROM. All IFT subjects reported significantly less pain
and had significantly greater range of motion at all post-operative time points. ACL and menisectomy
IFC subjects experienced significantly less edema at all time points, while chondroplasty subjects
experienced significantly less edema until 4 weeks postoperatively. The authors concluded that IFT
may help to reduce pain, need for pain medication and edema as well as enhance recovery of function
after knee surgery. The study is limited by subjective reporting of edema by patients, small treatment
and control groups and lack of comparison to other treatment modalities. In addition, the control group
was aware they were not receiving IFT thereby confounding the results.
Fourie and Bowerbank (1997) studied interferential therapy (IT) as a treatment to accelerate healing of
tibial fractures in a double blind, controlled, randomized study. Forty-one men received IFT, 35
received sham, and 151 received no intervention. Outcomes were measured by the time to union or
incidence of nonunion. No difference in the time for union was found in the three groups. The authors
concluded that IFT did not reduce healing time for new tibial fractures or prevent nonunion.
Limited success with interferential therapy was obtained by Hurley et al. (2001) who concluded that
during treatment of low back pain the interferential current must be applied to the associated spinal
nerve rather than the painful area. These investigators found a statistically significant reduction in
functional disability scores for the spinal nerve therapy group compared with the control group or the
painful area therapy group. However, differences in pretreatment status and treatment protocols for the
different patient groups in this study hamper interpretation of this finding. Moreover, no advantage was
observed for spinal nerve therapy in pain scores or quality of life scores.
In a later study, Hurley et al. (2004) investigated the outcomes of manipulative therapy and IFT for
acute low back pain. Eighty patients received manipulative therapy, 80 received IFT, and 80 received a
combination of both manipulative and interferential therapies. Functional disability was assessed by
the Roland Morris Disability Questionnaire. All interventions significantly reduced functional
disability to the same degree at discharge, 6 months and 12 months follow-up. At discharge all
interventions significantly reduced functional disability and there were no significant differences found
between the groups for recurrence of back pain, work absenteeism, medication consumption, exercise
participation or the use of healthcare at 12 months. The authors concluded that there was no difference
between the effects of a combined manipulative therapy and interferential therapy package and either
manipulative therapy or interferential therapy alone.
Page 14 of 24
A 2008 Hayes Directory Report on Interferential Therapy for Pain and Bone Fractures states there is a
lack of evidence that interferential therapy is effective for pain relief and tissue healing.
In 2005, the California Technology Assessment Forum (CTAF) concluded that interferential therapy
has not been shown to be as beneficial as the alternatives for the treatment of musculoskeletal pain.
Validated treatments for musculoskeletal pain include medication as necessary, such as
acetaminophen, nonsteroidal anti-inflammatory agents, muscle relaxants or opioids; discourage bed
rest, consider spinal manipulation for pain relief and refer for exercise therapy.
The body of evidence on interferential therapy (IFT) includes a number of randomized controlled trials
(RCTs) and a meta-analysis of RCTs. Several studies reported no significant difference between IFT
treatment groups compared to placebo or other co-interventions. Studies which have reported some
benefit of IFT treatment for pain have been limited by small sample size, limited follow-up, and lack
of placebo control groups. Overall, the evidence suggests that IFS is not efficacious for improving
pain, function and/or range of motion for patients with musculoskeletal conditions;
Professional Societies/Organizations:
The Work Loss Data Institute (2009) stated that “there is no quality evidence of effectiveness except
in conjunction with recommended treatments, including return to work, exercise and medications” and
the evidence of improvement was limited. The reported results from trials were negative or noninterpretable and study design and methodology were poor. There was a lack of standardized protocol
for IFT, and the therapies varied in electrode-placement technique, frequency of stimulation, pulse
duration, and treatment time.
Clinical practice guidelines from the American College of Physicians and the American Pain Society
published in 2007 concluded that there was insufficient evidence to recommend interferential
stimulation for the treatment of low back pain.
Pulsed Electrical Stimulation (PES)
The BioniCare Knee System( formerly Bio-1000 system), is a noninvasive, low-amplitude, pulsed
electrical stimulation (PES) device designed to reduce pain and improve function in patients with
osteoarthritis (OA) of the knee. The device consists of a signal generator, signal applicator, and
electrodes encased in either a supportive knee brace or a soft wrap. PES is delivered to the knee and
the brace is worn by the patient for ≥ 6 hours per day during waking hours; the soft wrap is used
overnight while sleeping. During an in-office consultation, the healthcare professional instructs the
patient in proper use of the device. PES is intended for patients with knee pain due to OA who do not
respond well to nonsteroidal, anti-inflammatory drug treatment or who are not appropriate candidates
for, or do not wish to undergo, total knee arthroplasty (TKA). Hayes Technology Brief (2011).
A double-blind, randomized, placebo-controlled trial by Fary et al. (2011) evaluated the effectiveness
of pulsed electrical stimulation in the symptomatic management of osteoarthritis (OA) of the knee.
Thirty-four patients were randomized to PES and 36 to placebo. Primary outcomes measured pain by
visual analog scale (VAS). Other measures included Western Ontario and McMaster Universities
Osteoarthritis Index (WOMAC) scores for pain, function, and joint stiffness, Short-Form 36 health
survey and perceived effect on quality of life and physical activity. Over 26 weeks, both groups
showed improvement in pain scores. There were no differences between groups for changes in
Page 15 of 24
WOMAC pain, function, and stiffness scores, SF-36 physical and mental component summary scores,
patient's global assessment of disease activity or activity measures. Fifty-six percent of the PES-treated
group achieved a clinically relevant 20-mm improvement in VAS pain score at 26 weeks compared
with 44% of controls. The authors concluded that PES was no more effective than placebo in
managing osteoarthritis of the knee.
A randomized controlled trial conducted and supported by the manufacturer of the BIO-1000 System
evaluated the analgesic potential and functional improvement following the use of PES in patients
(n=78) with osteoarthritis (OA) of the knee (Zizic, 1995). Patients were randomized to receive an
active device or a placebo device, both of which were used daily for 4 weeks. Three primary efficacy
variables (patient pain, patient function, and physician global evaluation of patient condition) and 6
secondary variables (duration of morning stiffness, range of motion, knee tenderness, joint swelling,
joint circumference, and walking time) were assessed. Patients treated with the active device
demonstrated significantly better improvement than the placebo group for all primary efficacy
variables in comparison of mean change from baseline to the end of treatment. There was 50%
improvement in all three primary efficacy variables in 24% of the active device group versus 6% of the
placebo group. No statistically significant differences were observed for tenderness, swelling, or
walking time. This study is limited by short follow-up, lack of power analysis, 9% of patients were not
evaluable at follow-up, and manufacturer sponsor.
Farr et al. (2006) reported on a prospective, cohort study examining the use of PES for the treatment of
osteoarthritis of the knee in 288 patients. The device was used for 16 to 600 days with a mean of 889
hours. Improvement in all efficacy variables was reported. A dose-response relationship between the
effect and hours of usage was observed as cumulative time increased to more than 750 hours.
Improvements in the patient's or physician's global evaluation of the patient's condition occurred in
59% of patients who used PES less than 750 hours and in 73% of patients who used it more than 750
hours. The lack of a control group weakens the evidence of this study.
Mont et al. (2006) examined the use of PES to defer total knee arthroplasty (TKA) for patients with
knee osteoarthritis. 157 patients who had been referred for a TKA were treated by PES daily for one
year. They were compared to a matched group of 101 patients. TKA was deferred for one year in 83%
of patients, for two years in 75% of patients, for three years in 65% of patients and for four years in
60% of patients. In the matched group, TKA was deferred for one year in 67% of patients, for two
years in 51% of patients, for three years in 46% of patients, and for four years in 35% of patients. The
differences in deferral were statistically significant and the investigators state that none of the
demographic variables studied influenced the need for TKA.
Peripheral Subcutaneous Field Stimulation (PSFS) or Peripheral Nerve Field Stimulation
(PNFS)
Subcutaneous stimulation (peripheral nerve field stimulation/PNFS) is a novel neuromodulation
modality that has increased in its utilization during the past decade.
In this particular treatment, an electrical current is transmitted via an electrode that has been implanted
around the selected peripheral nerve. This electrical current purports to block or disrupt the normal
transmission of pain signals. The electrodes are connected by a wire to the peripherally implanted
neurostimulator (also known as an implantable subcutaneous target stimulator). An external generator
(similar to a remote control device) controls the degree of stimulation the patient receives.
Page 16 of 24
Yakovlev et al. (2011) evaluated peripheral nerve field stimulation (PNFS) as an alternative treatment
option for patients with postlaminectomy syndrome (PLS) when conventional treatments did not
provide adequate relief of intractable low back pain. Eighteen patients underwent an uneventful PNFS
trial with percutaneous placement of four temporary quadripolar leads. The leads were placed
subcutaneously over the lumbar or thoraco-lumbar area. The temporary leads were removed when
patients experienced excellent pain relief over the next two days. The patients were then implanted
with permanent leads. All patients reported sustained pain relief 12 months after implantation. The
authors concluded that PNFS may be more effective in treating intractable low back pain than spinal
cord stimulation in patients with PLS after multilevel spinal surgeries. The lack of a control group
limits the validity of the conclusions of this study.
Verrills et al. (2011) evaluated the clinical outcomes of 100 consecutive patients receiving peripheral
nerve field stimulation (PNFS) for chronic pain in a prospective, observational study. The patients
received PNFS for the treatment of chronic craniofacial, thorax, lumbosacral, abdominal, pelvic, and
groin pain conditions. Overall, 72% of patients reduced their analgesic use following PNFS. Patients
receiving a lumbosacral PNFS for chronic low back pain reported a significant reduction in disability
following treatment, as determined by the Oswestry Disability Index. No long-term complications
were reported. The authors concluded that PNFS can be a safe and effective treatment option for
intractable chronic pain conditions. This study was not randomized or case controlled.
Six patients with failed back surgery syndrome who had failed conventional therapies were implanted
in the subcutaneous tissues of the low back region with neurostimulation leads. Leads were placed
superficially in the region of maximum pain, as identified by each individual patient. The use of
peripheral nerve field stimulation (PNFS) enabled patients to decrease their pain medication and
increase their level of activity. The patients all reported reduction in pain as measured by visual analog
scale scores and an improved quality of life. The authors concluded that PNFS is a safe and effective
alternative treatment for patients with chronic low back pain, and should be considered in this
population (Paicius, 2007). This study is limited by a small study population.
Evidence on PSFS is limited, consisting of small uncontrolled and case studies. Prospective controlled
trials are needed to evaluate the efficacy of this treatment for chronic pain.
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Several functional electrical stimulator devices have been approved by the FDA under product code
GZI. Additional information is available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm. Accessed December 2014
Interferential stimulators are regulated by the FDA as Class II devices under product codes LIH and
IPF. More than 50 instruments have received 510(k) approval.
A complete list of devices for IF is too extensive for inclusion in this report.
The FDA-approved list includes:
• Endomed 433, 582 and 982 Interferential Stimulators (Enraf Nonius, Delft, The Netherlands)
Page 17 of 24
• Galva Electrotherapy System (Zimmer Elektromedizin, Neu-Ulm, Germany)
• Omega Inter 4150 (Medical Industries Australia Pty. Ltd., Sydney, Australia)
• INF Plus™ ( Biomedical Life Systems Inc, Vista, CA)
• Stimtech® IF4 (Stitch, Amherst, NH)
• RSJ, RS JC (RS Medical, Vancouver, WA)
• IF 8000 (Biomotion, Madison, AL)
• RS-4i™ (RS Medical, Vancouver, WA)
Additional information is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm.
Accessed December 2014
Neuromuscular stimulators that restore ambulation to paraplegics are regulated as Class III or high-risk
devices by the U.S. Food and Drug Administration (FDA). The Parastep I received premarket approval
from the FDA on April 1994 under Application #P900038. Additional information is available at:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=13544. Accessed December
2014.
The WalkAide device received 501(k) approval September 21, 2005 as a neuromuscular functional
stimulator to electrically stimulate the muscles that cause ankle dorsiflexion in patients who have
sustained damage to upper motor neurons or pathways to the spinal cord. Additional information is
available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052329.pdf. Accessed December 2014.
The WalkAide is a product of Myo-Orthotics Technology, a term coined by the manufacturer,
Innovative Neurotronics (Austin, TX). According to the manufacturer, it represents the convergence of
orthotic technology (which braces a limb) and ES (which restores specific muscle function). The
WalkAide device is intended to counteract foot drop by producing dorsiflexion of the ankle during the
swing phase of the gait. The device attaches to the leg, just below the knee, near the head of the fibula.
During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis
anterior and other muscles that produce dorsiflexion of the ankle. The WalkAide is designed to offer
persons with foot drop increased mobility, functionality and independence. It was learned by the FDA
through the 510 (k) process. However, there is currently insufficient evidence to support its use for foot
drop and other indications. Prospective clinical studies of the WalkAide device are necessary to
evaluate whether it improves function and reduces disability compared to standard bracing in persons
with foot drop.
The NESS L300 received 510(k) marketing clearance on July 7, 2006. The NESS L300 is intended to
provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or
disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected
leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may
also facilitate muscle re-education, prevent/retard disused atrophy, maintain or increase joint range of
motion and increase local blood flow. Additional information is available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053468.pdf. Accessed December 2014
The ODFS Dropped Foot Stimulator (Odstock) received FDA approval on July 15, 2005. The ODFS is
intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor
neuron injury. During the swing phase of gait, the ODFS electrically stimulates muscles in the leg and
Page 18 of 24
ankle of partially paralyzed individuals to provide flexion of the foot and may thus improve the
individual’s gait. Additional information (product code GZI and IPF) is available at
http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050991.pdf . Accessed December 2014
A newer version, the ODFS Pace, received FDA approval on March 30, 2011. Additional information
is available at http://www.accessdata.fda.gov/cdrh_docs/pdf10/K102115.pdf Accessed December 2014
The NESS Neuromuscular Electrical Stimulation System or Handmaster was approved through 510(K)
on September 11, 2002. The most recent approval is under the name Handmaster in 2003. The NESS
System is intended to be used for the following indications: maintenance or increase of range of
motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation,
and increasing local blood circulation. Additional information is available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf3/K031900.pdf. Accessed December 2014.
ERGYS was approved as a powered muscle stimulator by the FDA under 510(k) number K841112 on
April 4, 1984. Additional information is available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed December 2014
The RT300 FES cycle ergometer was approved as a powered muscle stimulator for general
rehabilitation for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing
local blood circulation and maintaining or increasing range of motion on June 27, 2005. Additional
information is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090750.pdf. Accessed
December 2014
The BioniCare BIO-1000 System (product code NYN), a pulsed electrical stimulation system, is
classified as a stimulator, electrical, transcutaneous for arthritis device by the FDA and is designed to
help reduce pain and improve function in osteoarthritis of the knee. It received 510(k) approval on
June 6, 2003. Additional information is available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf3/K030332.pdf. Accessed December 2014.
Peripheral Subcutaneous Field Stimulation (PSFS) or Peripheral Nerve Field Stimulation (PNFS) using
a fully implantable system is not currently approved by the FDA. See the following Web site for more
information:
http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1306157336003&lang=en_U
S Accessed December 2014.
APPLICABLE CODES
The codes listed in this policy are for reference purposes only. Listing of a service or device code in
this policy does not imply that the service described by this code is a covered or non-covered health
service. Coverage is determined by the benefit document. This list of codes may not be all inclusive.
CPT Code
63650
Description
Percutaneous implantation of neurostimulator electrode array,
epidural -
Page 19 of 24
63655
63685
0282T
0283T
0284T
0285T
Laminectomy for implantation of neurostimulator electrodes,
plate/paddle, epidural
Insertion or replacement of spinal neurostimulator pulse generator or
receiver, direct or inductive coupling
Percutaneous or open implantation of neurostimulator electrode array(s).
subcutaneous (peripheral subcutaneous field stimulation), including imaging
guidance, when performed, cervical, thoracic or lumbar; for trial, including
removal at the conclusion of trial period.
…permanent, with implantation of a pulse generator
Revision or removal of pulse generator or electrodes, including imaging
guidance, when performed, including addition of new electrodes, when
performed
Electronic analysis of implanted peripheral subcutaneous field stimulation
pulse generator, with reprogramming when performed
CPT® is a registered trademark of the American Medical Association
HCPCS Code
E0744
E0745
E0762
E0764
E0770
L8679
L8680
L8681
L8682
L8683
L8685
L8686
L8687
L8688
L8689
S8130
S8131
Description
Neuromuscular stimulator for scoliosis
Neuromuscular stimulator, electronic shock unit
Transcutaneous electrical joint stimulation device system, includes all
accessories
Functional neuromuscular stimulation, transcutaneous stimulation of
sequential muscle groups of ambulation with computer control, used for
walking by spinal cord injured, entire system, after completion of training
program
Functional electrical stimulator, transcutaneous stimulation of nerve and/or
muscle groups, any type, complete system, not otherwise specified
Implantable neurostimulator, pulse generator, any type
Implantable neurostimulator electrode, each
Patient programmer (external) for use with implantable programmable
neurostimulator pulse generator, replacement only
Implantable neurostimulator radiofrequency receiver
Radiofrequency transmitter (external) for use with implantable
neurostimulator radiofrequency receiver
Implantable neurostimulator pulse generator, single array, rechargeable,
includes extension
Implantable neurostimulator pulse generator, single array, non-rechargeable,
includes extension
Implantable neurostimulator pulse generator, dual array, rechargeable,
includes extension
Implantable neurostimulator pulse generator, dual array, non-rechargeable,
includes extension
External recharging system for battery (internal) for use with implantable
neurostimulator, replacement only
Interferential current stimulator, 2 channel
Interferential current stimulator, 4 channel
Page 20 of 24
Coding Clarification
Transcutaneous electrical joint stimulation devices (E0762) are noninvasive devices that deliver lowamplitude pulsed electrical stimulation.
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Baldi JC, Jackson RD, Moraille R, Mysiw WJ. Muscle atrophy is prevented in patients with acute
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management of osteoarthritis of the knee: Results of a double-blind, randomized, placebo controlled,
repeated-measures trial. Arthritis Rheum. 2011 May;63(5):1333-42.
Fitzgerald GK, Piva SR, Irrgang JJ. A modified neuromuscular electrical stimulation protocol for
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Hayes, Inc. Medical Technology Directory. BioniCare Knee System (VQ OrthoCare) for
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Hayes, Inc. Medical Technology Directory. Functional Electrical Stimulation (FES) for Treatment of
Foot Drop in Multiple Sclerosis Patients Lansdale, PA: Hayes, Inc.; December 19, 2011.
Hayes, Inc. Medical Technology Directory. Functional Electrical Stimulation for Rehabilitation of
Paralyzed Lower Limbs. Lansdale, PA: Hayes, Inc.; May 2003. Updated March 24, 2008.
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PROTOCOL HISTORY/REVISION INFORMATION
Date
12/18/2014
02/27/2014
05/23/2013
02/28/2013
09/27/2012
12/15/2011
10/27/2011
01/28/2011
05/21/2010
06/26/2009
Action/Description
Corporate Medical Affairs Committee
The foregoing Health Plan of Nevada/Sierra Health & Life Health Operations protocol has been
adopted from an existing UnitedHealthcare coverage determination guideline that was researched,
developed and approved by the UnitedHealthcare Coverage Determination Committee.
Page 24 of 24

electrical stimulation for the treatment of pain & muscle rehabilitation

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