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.

 

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.

 

 

 

 

 

 

 

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.