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MP 1.01.27

Electrical Stimulation for the Treatment of Arthritis


Medical Policy    
Section
Durable Medical Equipment 
Original Policy Date

Last Review Status/Date
Reviewed with literature search/12:2014

Issue
12:2014

Return to Medical Policy Index

 


Disclaimer

 

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

Electrical stimulation has been used to improve functional status and relieve pain related to osteoarthritis and rheumatoid arthritis unresponsive to other standard therapies. Noninvasive electrical stimulators generate a weak electrical current within the target site using pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads/electrodes are placed on either side of the knee or wrist. Electrical stimulation is provided by an electronic device that noninvasively delivers a subsensory low-voltage, monophasic electrical field to the target site of pain. Pulsed electromagnetic fields are delivered via treatment coils that are placed over the skin. Combined magnetic fields deliver a time-varying magnetic field by superimposing the time-varying magnetic field onto an additional static magnetic field.

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. Therefore, pulsed electrical stimulation is proposed to be similar to bone stimulator therapy for fracture nonunion (see Policy No. 7.01.07).

Regulatory Status

The BioniCare Bio-1000™ stimulator is a device that has received U.S. Food and Drug Administration (FDA) 510(k) marketing clearances to deliver pulsed electrical stimulation for the treatment of osteoarthritis of the knee and rheumatoid arthritis of the hand. FDA gave the BioniCare Bio-1000™ clearance after finding it to be substantially equivalent to transcutaneous electrical nerve stimulation (TENS) 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. It is proposed that the device treats the underlying cause of the disease by stimulating the joint tissue and improving the overall health of the joint and that it provides a slow-acting, but longer-lasting improvement in symptoms.

The FDA’s 510(k) 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.

The OrthoCor™ Active Knee System (OrthoCor Medical) uses pulsed electromagnetic field energy at a radio frequency of 27.12 MHz to treat pain. The OrthoCor Knee System received marketing clearance from the FDA in 2009 and is classified as a shortwave diathermy device for use other than applying therapeutic deep heat (K091996, K092044). It is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue and for the treatment of muscle and joint aches and pain associated with overexertion, strains, sprains, and arthritis. The system includes single-use packs (pods) that deliver hot or cold and are supplied in packets of 15. The predicate devices are the OrthoCor (K091640) and Ivivi Torino II™ (K070541).

The SofPulse™ (also Torino II, 912-M10, and Roma3™, Ivivi Health Sciences) received marketing clearance in 2008 as short-wave diathermy devices that apply electromagnetic energy at a radio frequency of 27.12 MHz (K070541). They are indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Palermo is another name for a device marketed by Ivivi Health Sciences.

The Magnetofield (F& B International, Italy) and Elettronica Pagani (Energy Plus Roland Series, Italy) devices provide pulsed electromagnetic field therapy. They are currently marketed in Europe.


Policy

 

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


 Policy Guidelines

No applicable information 


Benefit Application

BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved devices may be assessed on the basis of their medical necessity. 


Rationale

This policy was created in 2006 and has been updated periodically using the MEDLINE database. The most recent literature update was performed through November 3, 2014.

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. 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 RCTs, ideally observed over an extended period of time, is needed to adequately assess electrical stimulation outcomes.

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).(1) The trials were published between 1994 and 2011, 5 were conducted outside of the United States, and only the trial by Fary et al(2) (see next section) 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 2013.3 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.

A number of the trials included in these meta-analyses are described next.(2,4-7)

Pulsed Electrical Stimulation (BioniCare)

Randomized Controlled Trials

In 2011, Fary et al reported results from a randomized double-blind sham-controlled trial of pulsed electrical stimulation in 70 patients with OA of the knee.(2) The device used in this study was a commercially available transcutaneous electrical nerve stimulation (TENS) 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 within-group 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 Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain, Function, and Stiffness scores, Short-Form 36-Item Health Survey (SF-36) Physical and Mental Component Summary scores, patient's global assessment of disease activity, or activity measures.

Zizic et al reported a 1995 multicenter, double-blind, randomized, placebo-controlled trial of pulsed electrical stimulation to assess pain relief and functional improvements in 78 patients with OA of the knee.(6) Patients used the BioniCare or placebo device for 6 to 10 hours daily for 4 weeks and were allowed to continue nonsteroidal anti-inflammatory drug (NSAID) therapy. The placebo group used a dummy device that initially produced a sensation like the BioniCare device. Both patient groups were instructed to dial down the level to just below the sensation threshold. 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 the patient’s condition. The authors reported that the BioniCare group had statistically significant improvement, defined as improvement of 50% or greater, 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 that longterm studies are warranted. In addition to longer term studies, larger studies would also be beneficial.

An industry-sponsored, randomized, double-blind, sham-controlled study of the BioniCare pulsed electrical stimulation device for 58 patients with OA of the knee was reported in 2007.(4) 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, respectively). 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%, 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, longer term larger controlled comparative studies are needed to evaluate this device.

Data on treatment of rheumatoid arthritis (RA) of the hand using the BioniCare device were presented to the American College of Rheumatology in November 2005.(8) The presentation reported on a double-blind placebo-controlled trial of 89 patients with RA in which statistically significant improvements in patient assessment of pain, symptoms, and function and physician global evaluation of the patients' condition were seen after 4 weeks of treatment. However, this study is not published, and longer term, larger studies appear to be needed based on the information presented.

Nonrandomized Controlled Trials

Reported in 2006 was a nonrandomized study of pulsed electrical stimulation in 157 patients (recruited from 23 centers) with moderate-to-severe knee OA who had received a recommendation for total knee arthroplasty (TKA).(9) Patients were instructed to use the electrical stimulation device for 6 to 10 hours per day. The time to TKA was compared with a historical matched (age, sex, weight) control group of 101 knee OA patients treated at one of the centers. Analysis showed that 60% of patients in the electrical stimulation group had deferred TKA at 4 years, compared with 35% in the historical control group. Interpretation is limited due to the potential for higher motivation to avoid TKA in the subjects who agreed to participate in the study.

Results of a 4-year study of the BioniCare device in 150 patients with moderate to severe knee OA who were candidates for TKA were described in a poster presentation at the 2004 American Academy of Orthopaedic Surgeons’ annual meeting.(10) The poster presenters reported that patients using the BioniCare device avoided TKA over 50% of the time (p<0.001) at 1-, 2-, 3-, and 4-year follow-up when compared with 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%).” This study’s design fails to meet the study selection criteria outlined here in that it did not have a randomly assigned control group.

Uncontrolled Trials

In 2006, the BioniCare manufacturer published data on 288 patients with knee OA treated with the BioniCare device in an open-label prospective study.(11) The study participants experienced improvements in patient assessment of pain and global evaluation of disease activity and physician global evaluation of the patients' condition. In addition, 45.4% reduced their use of NSAIDs by 50% or more. However, this study did not have a randomly assigned control group.

Pulsed Short-Wave Electromagnetic Field Stimulation (Diatermed II, SofPulse™, and OrthoCor™ Active Knee System)

In 2011, Fukada et al reported a double-blind RCT from South America that included 121 women divided into 4 groups, low (19-minute treatment) or high-dose (38-minute treatment) short-wave electrical field stimulation with a Diatermed II (9 sessions over 3 weeks), placebo, or no-treatment control.(12) Pain and function were measured with a numeric rating scale (NRS) and the Knee Osteoarthritis Outcome Score
(KOOS) at baseline, immediately after treatment, and at 1-year follow-up. Except for the untreated controls, both patients and the physical therapist evaluator were blinded throughout the 1-year follow-up. When measured immediately after treatment, both the low- and high-dose groups showed significantly greater improvement than the control groups in the numeric rating scale and KOOS subscales. For example, the NRS decreased from 7.7 to 6.9 in the placebo group, from 7.1 to 3.8 in the low-dose group, and from 6.7 to 4.6 in the high-dose group. The percentage of patients who attained the minimal clinically important difference of 2 points on the NRS was 15% in the control group, 15% in the placebo group, 75% in the low-dose group, and 50% in the high-dose group. At the 1-year follow-up, in the low-dose group, but not the high-dose group, significant improvement remained on 3 of 5 KOOS subscales. Because there was a 36% dropout rate (from patients lost to follow-up, patients who received other therapies, and patients who had a total knee replacement), analyses were performed both per-protocol and by last observation carried forward; these analyses yielded similar results.

A 2010 double-blind randomized controlled trial from Turkey investigated the effect of pulsed electromagnetic field therapy (PEMF) in 40 patients with knee OA.(5) Patients with an average pain intensity of 40 or more on a 100-mm VAS were randomly assigned to receive PEMF or sham PEMF in addition to their physical therapy. Sessions included 20-minute hot pack, 5-minute ultrasound, and 30-minute PEMF or sham and were provided 5 times per week for 2 weeks, along with isometric knee exercises performed at home. After 2 weeks, both groups showed improvement in pain and functional scores; there were no significant differences between the 2 groups.

Nelson et al reported a well-conducted, randomized, double-blind, placebo-controlled pilot study with the Palermo device in 34 patients with OA.(7) In addition to having knee pain with confirmed articular cartilage loss and an initial VAS score of 4 or more, only patients who had at least 2 hours of daily standing activity in a physical occupation were included in the study. Patients were instructed to use the electromagnetic device for 15 minutes twice daily, and the total number of sessions used was recorded by the device. An average 80 of 84 possible sessions were recorded. Patients were asked to self-report the maximum daily VAS pain score on a 10-cm line for weeks 1 and 2, and then for weeks 5 and 6. By the end of the study, 3 active and 7 sham patients had dropped out of the study due to a lack of perceived benefit. At baseline, there was no significant difference in VAS between the active (6.8) and sham (7.1) treatment groups. Using intention-to-treat analysis with last observation carried forward, the average decrease in VAS was 2.7 in the active treatment group (statistically significant) and 1.5 in the sham group (not statistically significant). By the end of the study, the maximum VAS decreased by 39% in patients receiving the active treatment and 15% in the sham group. The difference between groups (4.19 vs. 6.11) was statistically and clinically significant.

No RCTs with the OrthoCor Active Knee System were identified.

Summary of Evidence

A review of the literature has not found adequate evidence to indicate that the use of pulsed electrical or electromagnetic stimulation for the treatment of arthritis will result in improvements in health outcomes. A well-conducted meta-analysis from 2013 identified 7 randomized sham-controlled trials on treatment of osteoarthritis 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. No published studies for rheumatoid arthritis were identified. This evidence remains insufficient to evaluate the effect of this treatment on health outcomes. Additional study with a larger number of subjects is needed. Therefore, pulsed electrical or electromagnetic stimulation is considered investigational for the treatment of osteoarthritis and rheumatoid arthritis.

This evidence remains insufficient to evaluate the effect of this treatment on health outcomes. Therefore, pulsed electrical stimulation is considered investigational for the treatment of osteoarthritis and rheumatoid arthritis.

Practice Guidelines and Position Statements

The American Academy of Orthopaedic Surgeons published guidelines on the treatment of osteoarthritis of the knee in 2013.(13) 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.

U.S. Preventive Services Task Force Recommendations
Not applicable.

Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

References:

  1. Negm A, Lorbergs A, Macintyre NJ. Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with metaanalysis. Osteoarthritis Cartilage. Sep 2013;21(9):1281-1289. PMID 23973142
  2. Fary RE, Carroll GJ, Briffa TG, et al. 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. May 2011;63(5):1333-1342. PMID 21312188
  3. Li S, Yu B, Zhou D, et al. Electromagnetic fields for treating osteoarthritis. Cochrane Database Syst Rev. 2013;12:CD003523. PMID 24338431
  4. 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. Jun 2007;15(6):630-637. PMID 17303443
  5. Ozguclu E, Cetin A, Cetin M, et al. Additional effect of pulsed electromagnetic field therapy on knee osteoarthritis treatment: a randomized, placebo-controlled study. Clin Rheumatol. Aug 2010;29(8):927-931. PMID 20473540
  6. Zizic TM, Hoffman KC, Holt PA, et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol. Sep 1995;22(9):1757-1761. PMID 8523357
  7. Nelson FR, Zvirbulis R, Pilla AA. Non-invasive electromagnetic field therapy produces rapid and substantial pain reduction in early knee osteoarthritis: a randomized double-blind pilot study. Rheumatol Int. Aug 2013;33(8):2169-2173. PMID 22451021
  8. Caldwell J, Zizic T. 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 at American College of Rheumatology Annual Scientific Meeting, November, 2005. Presentation No. 1463; Poster Board No. 239 San Diego, California.
  9. Mont MA, Hungerford DS, Caldwell JR, et al. Pulsed electrical stimulation to defer TKA in patients with knee osteoarthritis. Orthopedics. Oct 2006;29(10):887-892. PMID 17061414
  10. He DY, Jones LC, Hoffman KC, et al. The use of electrical stimulation to avoid total knee arthroplasty Poster Presentation at American Academy of Orthopaedic Surgeons’ 71st Annual Meeting, March 10-14, 2004, Poster Board No. P170; San Francisco, California.
  11. Farr J, Mont MA, Garland D, et al. Pulsed electrical stimulation in patients with osteoarthritis of the knee: followup in 288 patients who had failed non-operative therapy. Surg Technol Int. 2006;15:227-233. PMID 17029181
  12. Fukuda TY, Alves da Cunha R, Fukuda VO, et al. Pulsed shortwave treatment in women with knee osteoarthritis: a multicenter, randomized, placebo-controlled clinical trial. Phys Ther. Jul 2011;91(7):1009-1017. PMID 21642511
  13. American Academy of Orthopaedic Surgeons. Treatment of osteoarthritis of the knee. 2013; http://www.aaos.org/research/guidelines/guidelineoaknee.asp. Accessed November 4, 2014.

Codes

Number

Description

CPT 

 

 

ICD-9 Procedure 

93.39 

Other physical therapy 

ICD-9 Diagnosis 

719.44 

Pain, joint, hand 

 

719.46 

Pain, joint, knee 

HCPCS 

E0762 

Transcutaneous electrical joint stimulation device system, includes all accessories 

ICD-10-CM (effective 10/1/15)      Investigational for the treatment of rheumatoid or osteoarthritis  
   M05.00-M05.9 Rheumatoid arthritis with rheumatoid factor code range  
   M06.00-M06.9 Other rheumatoid arthritis code range  
   M08.00-M08.99 Juvenile arthritis code range  
   M15.0-M19.93 Osteoarthritis code range  
ICD-10-PCS (effective 10/1/15)     ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for the initiation of this therapy. 

Type of Service 

Durable Medical Equipment 

Place of Service 

Home 
Inpatient
Outpatient 


Index

BioniCare Bio-1000 Stimulator
Electrical Stimulation, Arthritis
Electrical Stimulation, BioniCare Bio-1000
Pulsed Electrical Stimulation, BioniCare Bio-1000
 


Policy History
Date Action Reason
4/25/06 Add to Durable Medical Equipment section New policy
01/10/08 Revised Policy Policy updated with literature review; references 6, 7 added; policy statement unchanged. “Electromagnetic” removed from title and policy.
10/06/09 Revised policy Policy updated with literature review; reference number 8 added; policy statement unchanged.
10/08/10 Replace policy Policy updated with literature review; policy statement unchanged
10/04/11 Replace policy Policy updated with literature review through July 2011; reference 4 added and references reordered; policy statement unchanged
10/11/12 Replace policy Policy updated with literature review through August 2012; policy statement unchanged
12/12/13 Replace policy Policy updated with literature review through November 4, 2013; references 10-12 added; policy statement unchanged
12/11/14 Replace policy Policy updated with literature review through November 3, 2014; references 1, 3, and 13 added; policy statement unchanged