Coverage Policy Manual
Policy #: 2006012
Category: DME
Initiated: April 2006
Last Review: October 2018
  Electrical/Electromagnetic Stimulation for the Treatment of Arthritis

Description:
Electrical stimulation has been used to improve functional status and relieve pain related to osteoarthritis and rheumatoid arthritis unresponsive to other standard therapies. Electrical stimulation is provided by an electronic device that non-invasively delivers a low voltage, monophasic electrical field to the target site of pain.
 
The BioniCare Bio-1000™ stimulator is a device that has received Food and Drug Administration (FDA) 510K marketing clearances to deliver pulsed electrical stimulation for the treatment of osteoarthritis of the knee and rheumatoid arthritis of the hand. The FDA gave the BioniCare Bio-1000™ clearance after finding it to be substantially equivalent to transcutaneous electrical nerve stimulation devices.* The BioniCare system consists of an electronic 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 pulsed electrical currents of 0.0 to 12.0 volt output. It is recommended that the device be worn for at least 6 hours per day and patients are reported to often wear the device while sleeping.
 
The FDA’s 510K summaries specify 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 from rheumatoid arthritis of the hand.
 
The BioniCare system is contraindicated in patients with demand-type pacemakers and may interfere with other electronic devices.
 
*Please note transcutaneous electrical nerve stimulation (TENS) is addressed in Policy #1998154.

Policy/
Coverage:
Effective, April 2006
 
Electrical/electromagnetic stimulators are a specific contract exclusion in a majority of current contracts.
 
Electrical/electromagnetic stimulation for the treatment of arthritis/osteoarthritis is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, electrical/electromagnetic stimulation for the treatment of arthritis/osteoarthritis is considered investigational and is not covered.  Investigational services are an exclusion in the member benefit contract.
 
 

Rationale:
This policy was developed as a result of the FDA 510(k) marketing clearance of the BioniCare Bio-1000™ stimulator.
 
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.   
 
A review of the literature has not found adequate evidence to indicate the use of electrical/electromagnetic stimulation for the treatment of arthritis will result in improvements in health outcomes. Only 1 published study on the use of electrical/electromagnetic stimulation using the BioniCare device for osteoarthritis of the knee has been identified. No published studies of BioniCare for rheumatoid arthritis were identified.
 
Zizic, et al, 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.  Patients used the BioniCare or placebo device for 6-10 hours daily for 4 weeks and were allowed to continue NSAID therapy. The placebo group used a dummy device which initially produced a sensation like the BioniCare device. Both patient groups were instructed to dial down the level to just below the sensation threshold. And in the placebo group, the device would soon turn itself off. The primary outcomes assessed at baseline and after 4 weeks of treatment included patient assessment of pain and function, and physician global evaluation of patients' condition. The authors reported the BioniCare group had statistically significant improvement, defined as improvement of > or = 50%, in each of the primary outcomes assessed. The authors also assessed 6 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 reports short-term improvements with pulsed electrical stimulation using the BioniCare device, the authors note long-term studies are warranted. In addition to longer term studies, larger studies would also be beneficial. The Zizic trial was included in a Cochrane review of electromagnetic fields for the treatment of osteoarthritis that concluded there may be some benefit but further studies are needed. 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 4-year study of the BioniCare device in 150 patients with moderate to severe knee osteoarthritis who were candidates for total knee arthroplasty were presented as a poster presentation at the 2004 American Academy of Orthopedic Medicine meeting.  The poster presenters reported that patients using the BioniCare device 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 40%), function (mean 38%), and physician global evaluation (mean 38%).” The manufacturer is currently seeking publication of full results of this study. Nevertheless, this study’s design fails to meet the study selection criteria outlined above in that it did not have a randomly assigned control group.
 
In November 2005, the BioniCare manufacturer also released data on 288 patients with knee osteoarthritis treated with the BioniCare device in an open-label prospective study. The study participants experienced improvements in patient assessment of pain and global evaluation of disease activity, and physician global evaluation of patients' condition. Additionally, 45.4% reduced their use of NSAIDs by 50% or more. However, this study is not published and also did not have a randomly assigned group.
 
Finally, data on treatment of rheumatoid arthritis of the hand using the BioniCare device was presented to the American College of Rheumatology in November 2005.  The presentation reported on a double-blind placebo-controlled trial of 89 patients with rheumatoid arthritis in which statistically significant improvements in patient assessment of pain, symptoms and function, and physician global evaluation of patients' condition were seen after 4 weeks of treatment. However, this study is also not published and longer term, larger studies appear to be needed based on the information presented.
 
The 2003 American Academy of Orthopedic Surgeons clinical guidelines on osteoarthritis of the knee mention assistive devices for ambulation (cane), appropriate and occasionally modified footwear, and bracing.  There is no mention of electrical/electromagnetic stimulation.  
 
Nonpharmacologic treatments listed by Felson include exercise (resistance training, aerobic), unloading (cane, crutch, weight loss), realignment (braces, taping, shoe inserts) and acupuncture.
 
2009 Update
A search of the MEDLINE database was conducted through August 2009. In a systematic review of published literature, McCarthy and colleagues evaluated pulsed electromagnetic field therapy (PEMF) in the treatment of knee pain caused by osteoarthritis.  Five randomized controlled trials comparing PEMF to placebo were identified.  The authors conclude that PEMF is of little value in the treatment of osteoarthritic knee pain. “Current evidence would suggest that PEMF is unlikely to be a valuable contributor to multimodal rehabilitation of knee osteoarthritis” (McCarthy, 2006).
 
An overview of systematic reviews on the effectiveness of physical therapy on osteoarthritic knee pain published between 2000 and 2007 was conducted (Jamtvedt, 2008).  Two reviews of the effects of pulsed electromagnetic energy and electromagnetic fields were identified.   The review discussed above was included in this overview as well as one other review by Hulme and colleagues which is discussed in previously discussed in this policy.  The authors concluded that electromagnetic field therapy is no better than placebo in treating pain due to osteoarthritis of the knee.  
 
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 (Garland, 2007).  Due to protocol violations from one of the centers (other new treatments were provided during the study) an additional 42 subjects were excluded from the analysis. Patients were instructed to wear the devices for 6 hours or more each day (typically at night) and compliance, which was monitored with a timer in the device, was found to be similar in the 2 groups (63% to 66% of patients). At the end of 3 months of use, the percentage of patients who improved 50% or more was greater with the active device group for patient global (39% vs. 5%), patient pain (44% vs. 16%), and WOMAC pain (39% vs. 11%) subscales. The percentage of patients who improved 50% or more on the WOMAC stiffness (28% vs. 5%) and WOMAC function (23% vs. 5%) 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. The policy statement is unchanged.
 
2012 Update
A search of the MEDLINE database was conducted through August 2012.  One randomized controlled trial was identified. In 2011, Fary et al. reported results from a randomized double-blind sham-controlled trial of pulsed electrical stimulation in 70 patients with osteoarthritis of the knee (Fary, 2011). The device used in this study was a commercially available TENS (transcutaneous electrical nerve stimulator) unit that was modified to provide pulsed electrical stimulation. Participants were instructed to apply the device for a minimum of 6 hours a day. In the placebo group, the device turned itself off after 3 minutes. After 26 weeks of treatment, 59% of patients using the active device and 36% of controls had achieved target usage based on patient-maintained logs. Intention-to-treat analysis showed a statistically significant improvement in visual analog score (VAS) for pain over 26 weeks in both groups, but no difference between groups (VAS of 20 vs. 19 for controls on a 100-mm scale). There was no significant difference between groups in the proportion of patients who achieved a clinically relevant 20-mm improvement in VAS pain score at 26 weeks (56% vs. 44% of controls). There were no significant differences between groups for changes in WOMAC pain, function, and stiffness scores, short-form 36 (SF-36) physical and mental component summary scores, patient's global assessment of disease activity, or activity measures.
 
The results of this trial do not prompt a change in the coverage statement.
 
2014 Update
A literature search conducted through November 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A well-conducted meta-analysis from 2013 identified 7 randomized sham-controlled trials on treatment of OA of the knee. There was some evidence of an improvement in function but no evidence of an improvement in pain. These conclusions are limited by methodologic limitations and inconsistency of the study results.
 
Assessment of efficacy for therapeutic interventions involves a determination of whether the intervention improves health outcomes. The optimal study design for a therapeutic intervention is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes but are prone to biases such as noncomparability of treatment groups, the placebo effect, and variable natural history of the condition.
 
Two recent systematic reviews reached somewhat different conclusions. A 2013 meta-analysis by Negm et al, including 7 small sham controlled RCTs with a total of 459 patients, examined pulsed electrical stimulation (PES) or pulsed electromagnetic field (PEMF) for the treatment of knee osteoarthritis (OA) (Negm, 2013).
 
The trials were published between 1994 and 2011, 5 were conducted outside of the United States, and only the trial by Fary et al (described next ) was considered to be at low risk of bias. There was no significant difference between the active and sham groups for the outcome of pain. Physical function was significantly higher with PES/PEMF, with a standardized mean difference of 0.22. The internal validity of the included studies is limited due to a number of factors. There is a high risk of bias and inconsistent results reported. The studies all have small sample sizes, leading to imprecise estimates of treatment effect (wide confidence intervals around outcomes).
 
A 2013 Cochrane review on PES and PEMF included 9 studies, with a total of 636 patients, that were published between 1993 and 2013 (Li, 2013). Meta-analysis found that participants who were randomized to PES or PEMF rated their pain relief as greater than sham-treated patients by 15.10 more on a scale of 0 to 100 but found no statistically significant effect on function or quality of life. There was a high risk of bias for incomplete outcome data in 3 studies. For all 9 studies, there were inadequacies in reporting of study design and conduct, making it unclear whether there was bias due to selective outcome reporting.
 
The American Academy of Orthopaedic Surgeons published guidelines on the treatment of osteoarthritis of the knee in 2013 (AAOS, 2013). Due to the overall inconsistent finding for electrotherapeutic modalities, they were unable to make a recommendation for or against their use in patients with symptomatic osteoarthritis of the knee. The strength of the recommendation was inconclusive.
  
2016 Update
A literature search conducted through October 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Pulsed Short-Wave Electromagnetic Field Stimulation (Diatermed II, SofPulse™, OrthoCor™ Active Knee System)
The literature on PEMF consists primarily of small RCTs with a variety of devices and ranges of treatment times (10 minutes to 12 hours). Some studies compared active PEMF to sham PEMF alone; others compared active PEMF plus physical therapy to sham PEMF plus physical therapy. Most studies were conducted outside of the United States.
 
In 2016, Bagnato and colleagues reported a double-blind, sham-controlled trial of 12 hours nightly treatment with a wearable ActiPatch (Bagnato, 2016).  Sixty-six patients with OA were randomized and 60 completed the trial. After 1 month of treatment, there was a clinically significant decrease (25.5%) in VAS pain scores in the PEMF group compared with a 3.6% reduction in the sham group (effect size, -0.73; 95% CI, -1.24 to -0.19). WOMAC total score was reduced by 18.4% in the active treatment group compared to 2.3% for controls (effect size, -0.34; 95% CI, -0.85 to 0.17). SF-36 Physical Component Summary scores also improved significantly with nightly PEMF.
 
Wuschech and colleagues evaluated 10-minute daily treatment with the Magcell Arthro (Physiomed Elektromedizin) in a sham-controlled, double-blind, semirandomized study with 57 patients with OA (Wuschech, 2015).  Due to efficacy at the interim analysis, only the first 26 patients were randomized. The remainder was assigned to the active treatment group, although patients and assessors remained blinded to treatment condition. It is unclear whether this study was sufficiently powered, because power analysis indicated that 28 patients would be needed per group. Treatment was performed for 5 minutes, twice daily over 18 days. In the sham group, WOMAC total score was 56.9 at baseline and 56.2 at follow-up. In the active PEMF group, WOMAC total score decreased from 65.4 to 42.9. ITT analysis showed that the active PEMF group had a clinically and statistically significant reduction in pain (p<0.001) on the WOMAC compared to the sham group. Stiffness (p=0.032) and disability in daily activities (p=0.005) on the WOMAC were also significantly reduced in the active PEMF group.
 
A 2016, double-blind, sham-controlled RCT of 40 patients with knee OA also found no benefit of 20 minutes of PEMF (PMT Quattro PRO; ASA) during physical therapy sessions as measured on either the VAS or the WOMAC pain scale.13
 
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below:
 
(NCT02436590) an industry sponsored or cosponsored trial. A Prospective, Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee; planned enrollment 150; projected completion date Jul 2017.
 
2017 Update
A literature search conducted using the MEDLINE database through November 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through September 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
E0762Transcutaneous electrical joint stimulation device system, includes all accessories

References: AAOS Clinical Guideline on Osteoarthritis of the Knee. www.aaos.org; 2003.

American Academy of Orthopaedic Surgeons.(2013) Treatment of osteoarthritis of the knee. 2013; http://www.aaos.org/research/guidelines/guidelineoaknee.asp. Accessed November 4, 2014.

Bagnato GL, Miceli G, Marino N, et al(2016) Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). Apr 2016;55(4):755-762. PMID 26705327

Brouwer RW, van Raaij TM, et al.(2006) Brace treatment for osteoarthritis of the knee: a prospective randomized multicentre trial. Osteoarthritis Cartilage 2006; Mar 22[Epub ahead print].

Caldwell J, Zizic T.(2005) Pulsed electrical stimulation (PES) treatment of hand rheumatoid arthritis (RA) Improves patient pain, physician global evaluation of disease and patient functional assessment but causes a large placebo effect in tender and swollen joint counts. Presentation 1462; Am Coll Rheumatology Mtg 2005.

Dundar U, Asik G, Ulasli AM, et al.(2016) Assessment of pulsed electromagnetic field therapy with Serum YKL-40 and ultrasonography in patients with knee osteoarthritis. Int J Rheum Dis. Mar 2016;19(3):287-293. PMID 25955771

Fary RE, Carroll GJ, Briffa TG et al.(2011) The effectiveness of pulsed electrical stimulation in the management of osteoarthritis of the knee: results of a double-blind, randomized, placebo-controlled, repeated-measures trial. Arthritis Rheum 2011; 63(5):1333-42.

Felson DT.(2006) Osteoarthritis of the knee. NEJM 2006; 354:841-8.

Fitzgerald GK, Oatis C.(2004) Role of physical therapy in management of knee osteoarthritis. Curr Opin Rheumatol 2004; 16:143-7.

He DY, Jones LC, et al.(2004) The use of electrical stimulation to avoid total knee arthroplasty. Poster P170, Am Acad Orthopedic Med Mtg 2004.

Hochberg MC, Altman RD, April KT, et al.(2012) American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). Apr 2012;64(4):465-474. PMID 22563589

Hulme J, Robinson V, et al.(2002) Electromagnetic fields for the treatment of osteoarthritis. Cochrane Database Syst Rev; CD003523; 2002.

Jamtvedt G, Dahm KT, Christie A, et al.(2008) Physical therapy interventions for patients with osteoarthritis of the knee: an overview of systematic reviews. Phys Ther. 2008;88:123-126.

Li S, Yu B, Zhou D, et al.(2013) Electromagnetic fields for treating osteoarthritis. Cochrane Database Syst Rev. 2013;12:CD003523. PMID 24338431

McAlindon TE, Bannuru RR, Sullivan MC, et al.(2014) OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. Osteoarthritis Cartilage. Mar 2014;22(3):363-388. PMID 24462672

McCarthy CJ, Callaghan MJ, Oldham JA.(2006) Pulsed electromagnetic energy treatment offers no clinical benefit in reducing the apin of knn osteoarthritis: a systematic review. BMC Musculoskeletal Disorders 2006. 7:51.

Negm A, Lorbergs A, Macintyre NJ.(2013) Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with meta-analysis. Osteoarthritis Cartilage. Sep 2013;21(9):1281-1289. PMID 23973142

Negm A, Lorbergs A, Macintyre NJ.(2013) Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with meta-analysis. Osteoarthritis Cartilage. Sep 2013;21(9):1281-1289. PMID 23973142

Singh JA, Saag KG, Bridges SL, Jr., et al.(2016) 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. Jan 2016;68(1):1-26. PMID 26545940

Wuschech H, von Hehn U, Mikus E, et al.(2015) Effects of PEMF on patients with osteoarthritis: Results of a prospective, placebo-controlled, double-blind study. Bioelectromagnetics. Dec 2015;36(8):576-585. PMID 26562074

Zizic TM, Hoffman KC, et al.(1995) The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol 1995; 22:1757-61.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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