Durable Medical Equipment Section - Electrical Stimulation for the Treatment of Arthritis

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

Osteoarthritis is characterized by degeneration of articular cartilage with proliferation and remodeling of subchondral bone. Symptoms include joint stiffness, limitation of motion and pain. Osteoarthritis may affect any joint, increases significantly with age and standard treatment includes use of non-steroidal antiinflammatory medication (NSAID). Chronic NSAID use can be associated with side effects that are more common in the elderly. For these reasons, alternative non-surgical therapies for osteoarthritis are being researched.

Electrical stimulation has been proposed as a non-surgical treatment of osteoarthritis and rheumatoid arthritis. In basic research studies, pulsed electrical stimulation has been shown to alter chondrocyte-related gene expression in vitro and to have regenerative effects in animal models of cartilage injury.

The FDA has cleared for marketing the BioniCare BIO-1000 stimulator as a type of transcutaneous electrical nerve stimulation (TENS) device for use in osteoarthritis of the knee and rheumatoid arthritis of the hand. The BioniCare consists of an electrical stimulator device with electrical leads that are placed over the affected area and held in place with a lightweight, flexible wrap and Velcro fasteners. The battery-powered device delivers small electrical currents of 0.0 to 12.0 volt output. It is recommended that the device be worn for at least six hours per day. Patients are often reported to wear the device while sleeping.

The FDA’s 510(k) summary specifies that the BioniCare Stimulator, Model BIO-1000 is indicated for use as “an adjunctive therapy in reducing the level of pain and:

• Symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by the physician’s global evaluation (clinical studies); and
• Stiffness associated with pain and rheumatoid arthritis of the hand.”

The BioniCare stimulator is contraindicated in patients with demand-type pacemakers and may interfere with other electronic devices.

Policy/Criteria

Electrical stimulation for the treatment of osteoarthritis and rheumatoid arthritis is considered investigational.

Scientific Background

Interpretation of evidence regarding treatments for arthritis can be confounded by many factors including the natural variation of disease remission and progression in individual patients and subjective reporting. Therefore, evidence from large, rigorously designed randomized controlled trials, ideally observed over an extended period of time, is needed to adequately assess electrical stimulation outcomes. The following study selection criteria outlined in a 1996 TEC Assessment on transcutaneous electrical nerve stimulation (TENS) may be applied:

• The study contains original empirical data
• The study design includes a treatment group and a control group
• The study reports on a health outcome relevant to the pain condition treated
• The study uses a random assignment, control group design

While the FDA classified this device as a TENS unit, the manufacturer has indicated it is really a new category of device since it uses a different array of proprietary electrical amplitudes than a TENS unit and does not function to stimulate nerves. Rather, the BioniCare device is purported to stimulate chondrogenesis. In rabbit studies, the manufacturer found the device generated the development of new hyaline cartilage. (1)

A review of the published literature failed to return adequate evidence to indicate that the use of electrical stimulation for the treatment of arthritis will result in improvements in health outcomes.

Zizic and colleagues reported on a multicenter, double-blind, randomized, placebo-controlled trial of pulsed electrical stimulation to assess pain relief and functional improvements in 78 patients with osteoarthritis of the knee. (2) Patients used the BioniCare or placebo device for 6–10 hours daily for four weeks and were allowed to continue nonsteroidal anti-inflammatory drug (NSAID) therapy. The placebo group used a sham device that produced a sensation like the BioniCare device. Both patient groups were instructed to reduce the stimulation level to just below the sensation threshold. In the placebo group, the device would then turn itself off. The primary outcomes assessed at baseline and after four weeks of treatment included patient assessment of pain and function, and physician global evaluation of the patients' condition. The authors reported that the BioniCare group had statistically significant improvement, defined as improvement of at least 50%, in each of the primary outcomes assessed. The authors also assessed six secondary outcomes including duration of morning stiffness, range of motion, knee tenderness, joint swelling, joint circumference, and walking time. However, only a decrease in mean morning stiffness in the BioniCare group was statistically significant. While this study reported short-term improvements with pulsed electrical stimulation using the BioniCare device, the authors noted that larger, long-term studies are warranted. A Cochrane review of electromagnetic fields for the treatment of osteoarthritis which included the Zizic trial concluded that there may be some benefit but further studies are needed. (3) The Cochrane review also noted the Zizic trial was rated of high quality but it did not describe the randomization process, was funded by the manufacturer and did not focus on outcomes of clinical significance.

Results of a four year study of the BioniCare device in 157 patients were presented as a poster presentation at the 2004 meeting of the American Academy of Orthopaedic Surgeons.  (4) Patients in this study had moderate to severe knee osteoarthritis and were considered candidates for total knee arthroplasty.  The poster presenters reported that patients using the BioniCare system avoided total knee arthroplasty over 50% of the time (p=0.0004) at one, two, three and four year follow-up when compared to a matching group of 101 patients.  Study patients who avoided surgery also reported “significant improvements in pain scores (mean improvement 40%), function (mean improvement 38%), and physician global evaluation (mean 38%).”  Although the manufacturer has sought publication of the full results of this study, it remains unpublished.  This study does not have a randomly assigned control group.

An industry-sponsored, randomized, double-blind sham-controlled study of the BioniCare pulsed electrical stimulation device was reported for 58 patients with osteoarthritis of the knee. (5) Due to protocol violations from one of the centers (i.e., other new treatments were provided during the study) 42 of the original 100 subjects were excluded from the analysis. Patients were instructed to wear the devices for six hours or more each day, typically at night.  Compliance was monitored with a timer in the device and found to be similar in the two groups (63% to 66%, respectively). At the end of three months of use the percentage of patients who improved 50% or more was significantly greater in the active group than in the sham group for patient global (39% vs. 5%, respectively), patient pain (44% vs. 16%, respectively) and WOMAC pain (39% vs. 11%, respectively) subscales. The percentage of patients who improved 50% or more on the WOMAC stiffness (28% vs. 5%, respectively) and WOMAC function (23% vs. 5%, respectively) subscales showed the same trend but did not reach statistical significance in this sample. As indicated above, longer-term larger controlled comparative studies are needed to evaluate this device.

Also reported was an observational study of pulsed electrical stimulation in 157 patients recruited from 23 centers. Included in the study were patients with moderate to severe knee osteoarthritis who had received a recommendation for total knee arthroplasty (TKA). (6) Patients were instructed to use the electrical stimulation device for six to ten hours per day. The time to TKA was compared to a historical matched (age, gender and weight) control group of 101 knee osteoarthritis patients treated at one of the centers. Analysis showed that 60% of patients in the electrical stimulation group had deferred TKA at four years, compared with 35% in the historical control group. This study precludes interpretation due to the potential for higher motivation to avoid TKA in the subjects who agreed to participate in the study, as well as other design flaws such as lack of randomization and control group.

Based on the lack of published long term objective outcomes from randomized trials, conclusions cannot be reached concerning the effectiveness of pulsed electrical stimulation therapy in the treatment of osteoarthritis. An updated search of the MEDLINE database through December 21, 2007 failed to return any new published clinical trial data that alter the conclusions reached above.

References

1. BlueCross and BlueShield Association, Medical Policy Reference Manual, Policy No. 1.01.27
2. Zizic TM, Hoffman KC, Holt PA et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J of Rheum 1995;22:1757-1761
3. Hulme J, Robinson V, DeBie R et al. Electromagnetic fields for the treatment of osteoarthritis. Cochrane Database Syst Rev 2002; (1):CD003523
4. Mount MA, He DY, Jones LC et al. Abstract: The use of pulsed electrical stimulation (PES) to defer total knee arthroplasty (TKA) in patients with osteoarthritis (OA) of the knee. Presented at American Academy of Orthopaedic Surgeons annual meeting, March 2004
5. Garland D, Holt P, Harrington JT et al. A 3-month, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a highly optimized, capacitively coupled, pulsed electrical stimulator in patients with osteoarthritis of the knee. Osteoarthritis Cartilage 2007;15(6):630-7
6. Mont MA, Hungerford DS, Caldwell JR et al. Pulsed electrical stimulation to defer TKA in patients with knee osteoarthritis. Orthopedics 2006;29(10):887-92

Cross References

Electrical Stimulation Devices for Home Use; Regence Medical Policy Manual, Policy No. DME 11

Sympathetic Therapy for the Treatment of Pain; Regence Medical Policy Manual, Policy No. DME 65

Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds in the Home Setting; Regence Medical Policy Manual, DME 67

Functional Neuromuscular Stimulation to Provide Ambulation, Regence Medical Policy Manual, DME, Policy No. 56

Threshold Electrical Stimulation as a Treatment of Motor Disorders, Regence Medical Policy Manual, DME, Policy No. 57

Interferential Stimulation; Regence Medical Policy Manual, DME, Policy No. 66

DME Section Table of Contents