ELECTRICAL STIMULATION FOR THE TREATMENT OF PAIN & MUSCLE REHABILITATION

Transcription

1 Protocol: DME013 Effective Date: March 21, 2011 Table of Contents ELECTRICAL STIMULATION FOR THE TREATMENT OF PAIN & MUSCLE REHABILITATION COMMERCIAL COVERAGE RATIONALE... 1 MEDICARE & MEDICAID COVERAGE RATIONALE... 3 BACKGROUND... 7 CLINICAL EVIDENCE... 8 U.S. FOOD AND DRUG ADMINISTRATION (FDA) APPLICABLE CODES REFERENCES PROTOCOL HISTORY/REVISION INFORMATION 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. 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; 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; Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 1 of 16

2 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 (such as ERGYS and RT300) is not medically necessary for the treatment of disuse muscle atrophy in persons with spinal cord injury (SCI) who do not meet the requirements above. Further studies are needed to confirm that functional electrical stimulation promotes bone remineralization and prevents or reverses muscle atrophy. Functional electrical stimulation (such as Walkaide and NESS L300) is not medically necessary for the treatment of gait disorders (e.g., foot drop) of central neurologic origin including but not limited to stroke. 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. 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. Randomized, controlled trials are necessary to assess the durability of this procedure in comparison to other types of treatment. Interferential therapy (IFT) is medically necessary * for the treatment of pain associated with musculoskeletal disorders or injuries, and stimulating healing of nonsurgical soft tissue injuries. *Clinical evidence supporting the use of interferential therapy for the treatment of pain or non-surgical soft tissue injuries is limited and conflicting. UnitedHealthcare will continue to review clinical evidence surrounding interferential therapy for the treatment of pain or non-surgical soft tissue injuries and may modify this conclusion at a later date based upon the evolution of the published clinical evidence. 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 Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 2 of 16

3 osteoarthritis. Randomized, controlled trials are necessary to assess the durability of this procedure in comparison to other types of treatment. MEDICARE & MEDICAID COVERAGE RATIONALE Medicare covers electrical nerve stimulators when criteria are met. Refer to the NCD for Electrical Nerve Stimulators (160.7) available at: %3A1%3AElectrical+Nerve+Stimulators. Also see the NCD for Assessing Patient's Suitability for Electrical Nerve Stimulation Therapy ( ) available at: 7%2E1%3A2%3AAssessing+Patient%27s+Suitability+for+Electrical+Nerve+Stimulation+Therapy. Local Coverage Determinations (LCDs) exist and compliance with these policies is required where applicable. LCDs for spinal cord stimulation are available at: (Accessed July 26, 2010) For Medicare s coverage guidelines for neuromuscular electrical stimulation (NMES) and functional electrical stimulation (FES), refer to the NCD for Neuromuscular Electrical Stimulation (NMES) (160.12) available at: 12%3A2%3ANeuromuscular+Electrical+Stimulaton+%28NMES%29. Local Coverage Determinations (LCDs) do not exist at this time. (Accessed July 26, 2010) Medicare does not have a National Coverage Determination (NCD) for pulsed electrical stimulation (PES). Local Coverage Determinations (LCDs) do not exist at this time. (Accessed July 26, 2010) Medicare does not have a National Coverage Determination (NCD) for Interferential Therapy. Local Coverage Determinations (LCDs) for physical medicine and rehabilitation and outpatient physical and occupational therapy services exist supporting coverage for Interferential therapy when criteria are met. Compliance with these policies is required where applicable. These LCDs are available at: and (Accessed July 26, 2010) Medicare has a National Coverage Determination for Electrical Nerve Stimulators. The National Coverage Determination is as follows: 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 1. 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 Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 3 of 16

4 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 , such use of the stimulator is covered as part of the total diagnostic service furnished to the beneficiary rather than as a prosthesis. Central Nervous System Stimulators (Dorsal Column and Depth Brain Stimulators) 1. The implantation of central nervous system stimulators may be covered as therapies for the relief of chronic intractable pain, subject to the following conditions: Types of Implantations 1. There are two types of implantations covered by this instruction: a. 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. b. 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 a. Payment may be made for the implantation of dorsal column or depth brain stimulators or services and supplies related to such implantation, if all of the conditions listed below have been met: i. The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain, and ii. 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, and iii. 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), and iv. 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 v. Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation. Medicare has a National Coverage Determination for Neuromuscular Electrical Stimulation (NMES). The National Coverage Determination is as follows: Treatment of Muscle Atrophy Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 4 of 16

5 1. 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 non-neurological 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). (See of the NCD Manual for an explanation of coverage of medically necessary supplies for the effective use of NMES.) 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 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 one-on-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. 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), and 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, and 3. Persons that demonstrate brisk muscle contraction to NMES and have sensory perception electrical stimulation sufficient for muscle contraction, and 4. Persons that possess high motivation, commitment and cognitive ability to use such devices for walking, and 5. Persons that can transfer independently and can demonstrate independent standing tolerance for at least 3 minutes, and 6. Persons that can demonstrate hand and finger function to manipulate controls, and 7. Persons with at least 6-month post recovery spinal cord injury and restorative surgery, and 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, or 2. Severe scoliosis or severe osteoporosis, or 3. Skin disease or cancer at area of stimulation, or 4. Irreversible contracture, or 5. Autonomic dysflexia. Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 5 of 16

6 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. Additional therapy after the purchase of the DME would be limited by our general policies in converge of skilled physical therapy. Medicare does not have a National Coverage Determination or a Local Coverage Determination for Nevada for Pulsed Electrical Stimulation (PES). Medicare does not have a National Coverage Determination for Interferential Therapy. There is a Local Coverage Determination for Nevada for Physical Medicine and Rehabilitation Policy which supports coverage for Interferential Therapy. The Local Coverage Determination is as follows: Application of a modality to one or more areas; electrical stimulation (manual), each 15 minutes This modality includes the following types of electrical stimulation: 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. 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. Microamperage E-stimulation (MENS) has not been proven effective and will be denied as such. It is inappropriate to use the CPT code or for MENS therapy. Please refer to the procedure code for further instructions. E-Stim (Vital Stim) has not been proven effective and will be denied as such. It is inappropriate to Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 6 of 16

7 use the CPT code for E-Stim (Vital Stim). Please refer to the procedure code for further instructions. For Medicare and Medicaid Determinations Related to States Outside of Nevada: Please review Local Coverage Determinations that apply to other states outside of Nevada. 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. BACKGROUND 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) 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. 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) 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. Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 7 of 16

8 CLINICAL EVIDENCE Functional electrical stimulation (FES) 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). 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. 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). 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 Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 8 of 16

9 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. 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 (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 is also a study that NMES can be effective when used for quadriceps strength training following ACL reconstruction. 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). 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. No studies were found that compared NESS H200 with stand alone (standard) NMES or that NESS H200 provides better outcomes than NMES. Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 9 of 16

10 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. 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. Interferential therapy (IFT) 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 ). Patients in the test group had a greater decrease in the overall pain VAS (27.91 vs ; 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 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 Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 10 of 16

11 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. 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. Pulsed Electrical Stimulation (PES) 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 Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 11 of 16

12 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 patient's 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. 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: Accessed August 23, Interferential stimulators are regulated by the FDA as Class II devices under product codes LIH and IPF. Additional information is available at: Accessed August 23, 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 #P Additional information is available at: Accessed August 23, 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 Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 12 of 16

13 sustained damage to upper motor neurons or pathways to the spinal cord. Additional information is available at: Accessed August 23, The NESS L300 received 510(k) marketing clearance on July 7, 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: Accessed August 18, The NESS Neuromuscular Electrical Stimulation System or Handmaster was approved through 510(K) on September 11, The most recent approval is under the name Handmaster in 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: Accessed August 23, ERGYS was approved as a powered muscle stimulator by the FDA under 510(k) number K on April 4, Additional information is available at: Accessed August 19, 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, Additional information is available at: Accessed August 18, 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, Additional information is available at: Accessed August 23, Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 13 of 16

14 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. HCPCS Code E0744 E0745 E0762 E0764 E0770 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 Coding Clarification Transcutaneous electrical joint stimulation devices (E0762) are noninvasive devices that deliver lowamplitude pulsed electrical stimulation. REFERENCES Baldi JC, Jackson RD, Moraille R, Mysiw WJ. Muscle atrophy is prevented in patients with acute spinal cord injury using functional electrical stimulation. Spinal Cord. 1998;36: Belanger M, Stein RB, Wheeler GD, et al. Electrical stimulation: can it increase muscle strength and reverse osteopenia in spinal cord injured individuals? Arch Phys Med Rehabil. 2000;81: Burch FX, Tarro JN, Greenberg JJ, et al. Evaluating the benefits of patterned stimulation in the treatment of osteoarthritis of the knee: a multi-center, randomized, single-blind, controlled study with an independent masked evaluator. Osteoarthritis Cartilage 2008 Aug;16(8): California Technology Assessment Forum (CTAF). Interferential Stimulation For The Treatment Of Musculoskeletal Pain. October 19, Cauraugh JH and Kim SB. Chronic stroke motor recovery: duration of active neuromuscular stimulation. J Neurol Sci Nov 15;215(1-2):13-9. Chen SC, Lai CH, Chan WP, et al. Increases in bone mineral density after functional electrical stimulation cycling exercises in spinal cord injured patients. Disabil Rehabil. 2005;27(22): Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 14 of 16

15 Daly JJ, Roenigk K, Holcomb J, et al. A randomized controlled trial of functional neuromuscular stimulation in chronic stroke subjects. Stroke Jan;37(1): Embrey DG, Holtz SL, Alon G, et al. Functional electrical stimulation to dorsiflexors and plantar flexors during gait to improve walking in adults with chronic hemiplegia. Arch Phys Med Rehabil May;91(5): Farr J, Mont MA, Garland D, et al. Pulsed electrical stimulation in patients with osteoarthritis of the knee: follow up in 288 patients who had failed non-operative therapy. Surg Technol Int. 2006;15: Fitzgerald GK, Piva SR, Irrgang JJ. A modified neuromuscular electrical stimulation protocol for quadriceps strength training following anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther Sep;33(9): Fourie JA, Bowerbank P. Stimulation of bone healing in new fractures of the tibial shaft using interferential currents. Physiother Res Int. 1997;2(4): Fuentes JP, Armijo Olivo S, Magee DJ, et al. Effectiveness of Interferential Current Therapy in the Management of Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Phys Ther Jul 22. Hayes, Inc. Medical Technology Directory. Functional Electrical Stimulation for Rehabilitation of Paralyzed Lower Limbs. Lansdale, PA: Hayes, Inc.; May Updated March 24, Hayes, Inc. Medical Technology Directory. Interferential Therapy for Pain and Bone Fractures. Lansdale, PA: Hayes, Inc.; April 28, Updated April 20, Hayes, Inc. Medical Technology Directory. Neuromuscular Electrical Stimulation for Muscle Rehabilitation. Lansdale, PA: Hayes, Inc.; January 3, Updated January 3, Hurley DA, Minder PM, McDonough SM, et al. Interferential therapy electrode placement technique in acute low back pain: a preliminary investigation. Arch Phys Med Rehabil. 2001;82(4): Hurley DA, McDonough SM, Dempster M, et al. A randomized clinical trial of manipulative therapy and interferential therapy for acute low back pain. Spine. 2004;29(20): Jarit GJ, Mohr KJ, Waller R, Glousman RE. The effects of home interferential therapy on postoperative pain, edema, and range of motion of the knee. Clin J Sport Med. 2003;13(1): Kesar TM, Perumal R, Reisman DS,et al. Functional electrical stimulation of ankle plantarflexor and dorsiflexor muscles: effects on poststroke gait. Stroke Dec;40(12): Epub 2009 Oct 15. Klose KJ, Jacobs PL, Broton JG, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep 1 ambulation system: part 1. Ambulation performance and anthropometric measures. Arch Phys Med Rehabil. 1997;78: Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 15 of 16

16 Mont MA, Hungerford DS, Caldwell JR, et al. Pulsed electrical stimulation to defer TKA in patients with knee osteoarthritis. Orthopedics 2006;29(10): National Institute for Health and Clinical Excellence (NICE). Functional electrical stimulation for drop foot of central neurological origin: guidance. January 28, Available at: Accessed on August 18, Needham-Shropshire BM, Broton JG, Klose KJ, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep 1 ambulation system: part 3. Lack of effect on bone mineral density. Arch Phys Med Rehabil. 1997;78: Ring H, Rosenthal N. Controlled study of neuroprosthetic functional electrical stimulation in subacute post-stroke rehabilitation. J Rehabil Med Jan;37(1):32-6. Wieler M, Stein RB, Ladouceur M, et al. Multicenter evaluation of electrical stimulation systems for walking. Arch Phys Med Rehabil. 1999;80: Zizic TM, Hoffman KC, Holt PA, et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol. 1995;22(9): PROTOCOL HISTORY/REVISION INFORMATION Date 01/28/ /21/ /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. Electrical Stimulation for the Treatment of Pain & Muscle Rehabilitation Page 16 of 16