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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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B. Treatment to improve wrist and finger function and prevent or correct shoulder subluxation in persons with partial paralysis following stroke Pulsed electrical stimulation (PES) is unproven for the treatment of osteoarthritis. There is insufficient evidence to conclude that PES provides any significant health benefit to patients with osteoarthritis. Preliminary evidence suggests PES may improve symptoms and function and may delay the need for total knee arthroplasty in patients with severe osteoarthritis of the knee. Randomized, controlled trials are necessary to assess the durability of this procedure in comparison to other types of treatment.

For additional information, see the following related medical policies:

• Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Nausea and Vomiting

• Acupuncture for the Treatment of Nausea and Pain Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Commercial Medical Management Guideline Regulatory Requirements U.S. Food and Drug Administration (FDA): 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 9/23/2005.

Additional information is available at: http://www.fda.gov/cdrh/pdf6/K062325.pdf. Accessed February 2, 2009.

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. Electrical stimulators that are used to provide stationary exercise for paraplegics or to correct gait disorders for hemiplegic patients are FDA Class II devices and 37 have received 510(k) approval. Additional information is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA.cfm?ID=4991. Accessed February 2, 2009.

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.fda.gov/cdrh/pdf2/k022776.pdf. Accessed February 3, 2009.

Research Evidence Background 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.

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) Functional electrical stimulation (FES) 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) Research Pulsed Electrical Stimulation (PES) A random 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 Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Commercial Medical Management Guideline versus 6% of the placebo group. No statistically significant differences were observed for tenderness, swelling, or walking time. A short follow-up and lack of power analysis limited the quality of the study. Furthermore, 9% of the enrolled patients were not evaluable at follow-up. Because the manufacturer conducted and supported the study, investigator bias cannot be excluded.

Farr et al. reported on a prospective, cohort study examining the use of PES for the treatment of osteoarthritis of the knee in 288 patients (Farr, 2006). 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. examined the use of PES to defer total knee arthroplasty (TKA) for patients with knee osteoarthritis (Mont, 2006). 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.

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.

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 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 (Cauraugh, 2003).

In a randomized, controlled study by Ring and Rosenthal, 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 (Ring, 2005). 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.

No studies were found that compared NESS H200 with stand alone (standard) NMES or that NESS H200 provides better outcomes than NMES.

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 Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Commercial Medical Management Guideline 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.

Functional electrical stimulation (FES) for rehabilitation of paralyzed lower limbs 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. utilized patients with less than 4 months of atrophy (Baldi, 1998). Moreover, electrically stimulated isometric exercise stimulated bone remineralization that was not observed with electrically stimulated walking (NeedhamShropshire, 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.

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).

References and Resources Resources Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Commercial Medical Management Guideline 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;36:463-469.

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;81:1090-1098.

Cauraugh JH and Kim SB. Chronic stroke motor recovery: duration of active neuromuscular stimulation. J Neurol Sci.

2003 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):1337-41.

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