Medical Policies - Medicine


Electrical Stimulation for the Treatment of Arthritis

Number:MED201.042

Effective Date:06-15-2018

Coverage:

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Electrical or electromagnetic stimulation is considered experimental, investigational and/or unproven for the treatment of osteoarthritis or rheumatoid arthritis.

Description:

Electrical and electromagnetic stimulation are being investigated to improve functional status and to relieve pain related to osteoarthritis (OA) and rheumatoid arthritis that are 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 placed over the skin. Combined magnetic fields deliver a time-varying field by superimposing that 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. 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. Therefore, pulsed electrical stimulation is proposed to be similar to bone stimulator therapy for fracture nonunion.

Regulatory Status

The BioniCare Bio-1000™ stimulator (VQ OrthoCare) was cleared for marketing by the United States (U.S.) Food and Drug Administration (FDA) through the 510(k) process to deliver pulsed electrical stimulation for adjunctive treatment of OA of the knee and rheumatoid arthritis of the hand. The FDA determined that this device was substantially equivalent to transcutaneous electrical nerve stimulation (TENS) devices. The BioniCare System consists of an electronic stimulator device with electrical leads placed over the affected area and held in place with a lightweight, flexible wrap, and self-adhesive fasteners. The battery-powered device delivers small pulsed electrical currents of 0.0- to 12.0-V output. FDA product code: NYN.

The OrthoCor™ Active Knee System (OrthoCor Medical; acquired by Caerus Corp. in 2016) uses pulsed electromagnetic field energy at a radiofrequency of 27.12 MHz to treat pain. In 2009, the OrthoCor Knee System was cleared for marketing by the FDA through the 510(k) process 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. The predicate devices are the OrthoCor (K091640) and Ivivi Torino II™ (K070541). FDA product code: ILX.

In 2008, the SofPulse™ (also called Torino II, 912-M10, and Roma3™; Ivivi Health Sciences – renamed Amp Orthopedics) was cleared for marketing by the FDA through the 510(k) process as a short-wave diathermy device that applies electromagnetic energy at a radiofrequency of 27.12 MHz (K070541). The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. The Palermo device (Ivivi Health Sciences) is a portable battery-operated device. FDA product code: ILX.

In 2017, the ActiPatch® (BioElectronics) was cleared for marketing by the FDA through the 510(k) process for over-the-counter use for adjunctive treatment of plantar fasciitis of the heel and OA of the knee. FDA product code: PQY.

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.

Rationale:

This medical policy was originally created in June 2014 and has been updated regularly with searches of the MEDLINE database. The most recent literature review was performed through January 25, 2017.

Assessment of the efficacy of 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 on 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 or electromagnetic stimulation outcomes.

Two systematic reviews have reached somewhat different conclusions. A 2013 systematic review by Negm et al. which included 7 small sham-controlled randomized trials (total N=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 (U.S.), 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 improved with PES and PEMF, with a standardized mean difference of 0.22. The internal validity of the selected studies was limited, including a high risk of bias, inconsistent results, and imprecise estimates of treatment effect (wide confidence intervals [CI] around estimates) due to small samples sizes.

A 2013 Cochrane review of PES and PEMF included 9 studies (total N=636 patients) published between 1993 and 2013. (3) Meta-analysis found that patients randomized to PES or PEMF rated their pain relief as better than sham-treated patients by 15.10 points more (95% CI, 9.08 to 21.13; absolute improvement, 15%) on a scale of 0 to 100, but found no statistically significant effect for function or quality of life. There was a high risk of bias due to incomplete outcome data in 3 studies. For all 9 studies, there were inadequacies in reporting of study designs and trial conduct, making it unclear whether there was selective outcomes reporting bias.

A number of the trials included in these meta-analyses are described briefly next and summarized in Table 1. (2, 4-13)

Pulsed Electrical Stimulation (BioniCare)

Randomized Controlled Trials (RCTs)

In 2011, Fary et al. reported results from a randomized, double-blind, sham-controlled trial of PES in 70 patients with OA of the knee. (2) The device used in this study was a commercially available transcutaneous electrical nerve stimulation unit (BioniCare) modified to provide PES. In the placebo group, the device turned itself off after 3 minutes. There were no statistically significant differences between the groups in terms of pain, Western Ontario and McMaster University Arthritis Index (WOMAC) scores, or 36-Item Short-Form Health Survey (SF-36) scores (see Table 1).

An industry-sponsored, randomized, double-blind, sham-controlled study of the BioniCare device for 58 patients with OA of the knee was reported in 2007. (4) Due to protocol violations from 1 of the centers (other new treatments were provided during the study), 42 subjects were excluded from the analysis. At the end of 3 months of use, improvements in pain and WOMAC scores were statistically significantly greater in the active device group than in the sham group (see Table 1).

Zizic et al. reported on a 1995 multicenter, double-blind, randomized, sham-controlled trial of PES to assess pain relief and functional improvements in 78 patients with OA of the knee. (5) Patients in the treatment group used the BioniCare device and 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. Trialists reported that the BioniCare group had statistically significant improvement (defined as improvement ≥50%) compared with the sham group for each of the primary outcomes assessed (see Table 1).

Nonrandomized Controlled Trials

Reported in 2006 was a nonrandomized study of PES in 157 patients (recruited from 23 centers) with moderate-to-severe knee OA who required total knee arthroplasty (TKA). (6) The time to TKA was compared with a historical matched (age, sex, weight) control group of 101 knee OA patients treated at 1 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 was limited due to the potential for higher motivation to avoid TKA in the subjects who participated.

Uncontrolled Trials

In 2006, VQ OrthoCare published data on 288 patients with knee OA treated with its BioniCare device in an open-label prospective study. (7) Study participants experienced improvements in patient assessment of pain, global evaluation of disease activity, and physician global evaluation of patients' condition (see Table 1). In addition, 45.4% reduced their use of nonsteroidal anti-inflammatory drugs by 50% or more. However, this study did not include a randomize control group.

Pulsed Electromagnetic Stimulation

The literature on PEMF consists primarily of small RCTs with a variety of devices and ranges of treatment times (10 minutes to 12 hours). Most studies were conducted outside of the U.S.

PEMF versus Sham PEMF

In 2016, Bagnato et al. reported a double-blind, sham-controlled trial of 12 hours nightly treatment with a wearable ActiPatch. (8) Sixty-six patients with OA were randomized and 60 completed the trial. Patients in the treatment group showed statistically significant improvements in pain, WOMAC scores, and SF-36 physical scores (see Table 1).

Wuschech et al. evaluated 10-minute daily treatment with the Magcell Arthro (Physiomed Elektromedizin) in a sham-controlled, double-blind, semi-randomized study with 57 patients with OA. (9) 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 allocation. It is unclear whether this study was sufficiently powered, because power analysis indicated that 28 patients would be needed per group. Statistically significant improvements in WOMAC scores were reported by the treatment group compared with the sham group (see Table 1).

Nelson et al. (2013) reported a randomized, double-blind, sham-controlled pilot study with the Palermo device in 34 patients with OA. (10) In addition to having knee pain with confirmed articular cartilage loss and an initial visual analog scale (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. Using intention-to-treat analysis with last observation carried forward, significant decreases in pain scores were seen at 14 and 42 days (see Table 1). By 6 months, the maximum VAS recorded score decreased by 39% in patients in the active treatment and by 15% in the sham group. The difference in VAS scores between groups (4.19 for PEMF vs 6.11 for sham) was statistically and clinically significant. No additional studies with this device have been identified.

In 2011, Fukuda et al. reported on a double-blind RCT from South America that included 121 women with OA 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. (11) 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 the high-dose groups showed significantly greater improvement than the control groups in the numeric rating scale (NRS) and the Knee Osteoarthritis Outcome Score (KOOS) subscale scores. The percentages of patients who attained the minimal clinically important difference of 2 points on the NRS were 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, larger improvements in the KOOS subscales were maintained by patients in the PEMF groups (see Table 1). Because there was a 36% dropout rate (from patients lost to follow-up, patients who received other therapies, patients who had total knee replacement), analyses were performed both per-protocol and by last observation carried forward; these analyses yielded similar results.

No RCTs with the OrthoCor Active Knee System were identified.

PEMF Plus Physical Therapy versus Sham PEMF Plus Physical Therapy

A 2016, double-blind, sham-controlled randomized trial of 40 patients with knee OA evaluated 20 minutes of PEMF plus 1 hour of physical therapy and 20 minutes of sham PEMF plus 1 hour of physical therapy. Both groups-PEMF (PMT Quattro PRO; ASA) plus physical therapy and sham PEMF plus physical therapy-showed equally significant improvements in pain scores (see Table 1). (12)

A 2010, double-blind RCT from Turkey investigated the effect of PEMF plus physical therapy in 40 patients with knee OA. (13) Patients with an average pain intensity of 40 or more on a 100-mm VAS were randomized to PEMF plus physical therapy or to sham PEMF plus physical therapy. Sessions included a 20-minute hot pack application, 5-minute ultrasound application, and 30 minutes of active or sham PEMF 5 times a week for 2 weeks, along with isometric knee exercises performed at home. After 2 weeks, both groups showed improvements in pain and function scores on the WOMAC, but between-group differences were not statistically significant.

Table 1. Summary of Trials Using PES or PEMF to Treat Patients With OA

Trial

Design

N

Treatment

Comparator

Results

PES

Fary et al. (2011) (2)

RCT

70

≥6 h/d for 26 wk

Sham device

Between-group mean change difference:

VAS pain (0-100): 0.9 (95% CI, -11.7 to 13.4).

VAS activity (90-100): -2.8 (95% CI, -13.9 to 8.4).

WOMAC total: -1.3 (95% CI, -8.8 to 6.3).

SF-36 MCS: 1.7 (95% CI, -1.5 to 4.8).

SF-36 PCS: 1.2 (95% CI, -2.9 to 5.4).

Garland et al. (2007) (4)

RCT

58

≥6 h/d for 3 mo

Sham device

Between-group mean change difference:

VAS global (0-100): 50.6 (p=0.03).

VAS pain (0-100): 31.2 (p=0.04).

WOMAC total: 26.7 (p=0.01).

Zizic et al. (1995) (5)

RCT

78

6-10 h/d for 4 wk

Sham device

Mean scores:

Physician global assessment:

o Sham: 32.8 vs Treatment: 12.4 (p=0.02).

Patient-evaluated pain:

o Sham: 29.4 vs Treatment: 10.2 (p=0.04).

Patient-evaluated function:

o Sham: 27.1 vs Treatment: 7.5 (p=0.02).

Mont et al. (2006) (6)

Cohort

258

6-10 h/d until TKA

Historical match

Time to TKA deferral of 4 y:

PES treatment group: 60%.

Historical control group: 35%.

Farr et al. (2006) (7)

Cohort

288

16-600 d (mean,

889 h)

NA

Mean change from baseline:

Physician global: 0.66 (p<0.001).

Patient global: 0.75 (p<0.001).

Overall pain: 0.66 (p<0.001).

PEMF

Bagnato et al. (2016) (8)

RCT

60

12 h/d for 1 mo

Sham device

Between group mean change difference:

VAS pain: -13.6 (95% CI, -19.3 to -7.9).

WOMAC total: -20.8 (95% CI, -32.6 to -8.9).

SF-36 PCS: 2.7 (95% CI, 0.3 to 5.2).

SF-36 MCS: 0.5 (95% CI, -1.5 to 2.6).

Wuschech et al. (2015) (9)

RCT

57

Two 5-min sessions/day for 18 d

Sham device

Mean change from baseline:

WOMAC pain:

o Sham: 1.3 vs Treatment: -5.7 (p<0.001).

WOMAC total:

o Sham: -0.7 vs Treatment: -23.5 (p=0.003).

Nelson et al (2013) (10)

RCT

34

Two 15-min sessions/day for 14 d

Sham device

Mean VAS (0-10) at 14 days:

o Sham: 6.21; Treatment: 4.08 (p=0.011)

Mean VAS (0-10) at 42 days:

o Sham: 6.11; Treatment: 4.19 (p=0.036)

Fukuda et al (2011) (11)

RCT

121

3 treatment groups:

Placebo (sham device).

Low-dose (three 19-min sessions/wk).

High dose (three 38-min sessions/wk) for 3 wk.

No treatment

Mean change difference (95% CI) vs no treatment group at 12-mo follow-up:

KOOS symptoms

o Sham: -1.3 (7.4).

o Low-dose: 15.1 (11.5).

o High-dose: 7.9 (11.5).

KOOS pain

o Sham: -5.0 (8.5).

o Low-dose: 20.1 (10.9).

o High-dose: 15.1 (9.6).

Dundar et al. (2016) (12)

RCT

40

60-min hot pack, ultrasound, TENS, isometric knee exercises plus 20 min PEMF, for 4 wk.

60-min hot pack, ultrasound, TENS, isometric knee exercises plus 20 min sham PEMF for 4 wk.

Mean change p values:

VAS (0-100) pain:

o Sham: p=0.001; Treatment: p<0.001; Between- groups: p=0.90.

WOMAC total:

o Sham: p=0.027; Treatment: p=0.007; Between- groups: p=0.36.

Ozguclu et al. (2010) (13)

RCT

40

20-min hot pack, 5- min ultrasound, and 30-min PEMF, plus PT, for 10 sessions over 2 wk.

20-min hot pack, 5- min ultrasound, and 30-min sham PEMF, plus PT, for 10 sessions over 2 wk.

Mean difference:

WOMAC pain:

o Sham: 5.45 vs Treatment: 5.30 (p=0.91).

VAS pain:

o Sham: 3.66 vs Treatment: 3.96 (p=0.64).

Table Key: CI: confidence interval; KOOS: Knee Injury and Osteoarthritis Outcome Score; MCS: Mental Component Summary; N: Number; NA: not applicable; PCS: Physical Component Summary; PEMF: pulsed short-wave electromagnetic field stimulation; PES: pulsed electrical stimulation; PT: physical therapy; RCT: randomized controlled trial; SF-36: 36-Item Short-Form Health Survey; TENS: transcutaneous nerve stimulation; TKA: total knee arthroplasty; VAS: visual analog scale; WOMAC: Western Ontario and McMaster University Arthritis Index.

Ongoing and Unpublished Clinical Trials

Currently ongoing and unpublished trials that may influence this review are listed in Table 2.

Table 2. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT01838954

The Effect of Short-wave Diathermy in Patients with Osteoarthritis of the Hand: A Randomized, Double Blinded, Placebo Controlled Trial

90

Sep 2016 (ongoing)

NCT02696083a

Proof of Concept Study of PEMF (Pulsed Electromagnetic Field Therapy in Subjects with Osteoarthritis of the Knee

14

Nov 2016 (ongoing)

NCT02436590a

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

150

Jul 2018

Table Key: NCT: national clinical trial; a: Denotes industry-sponsored or cosponsored trial.

Practice Guidelines and Position Statements

Osteoarthritis Research Society International (OARSI)

In 2014, OARSI published evidence-based consensus guidelines for nonsurgical management of knee osteoarthritis (OA). (14) Twenty-nine treatment modalities were evaluated for 4 patient groups: knee only OA, knee-only OA with comorbidities, multi-joint OA, and multi-joint OA with comorbidities. Neuromuscular electrical stimulation was considered “not appropriate” for all 4 groups. Evidence consisted of a systematic review and meta-analysis of randomized controlled trials. The quality of the evidence was considered fair.

American Academy of Orthopaedic Surgeons (AAOS)

The AAOS published guidelines on the treatment of OA of the knee in 2013. (15) Due to the overall inconsistent finding for electrotherapeutic modalities, AAOS did not recommend for or against use in patients with symptomatic knee OA. The strength of the recommendation was inconclusive.

American College of Rheumatology (ACR)

In 2012, the ACR published recommendations on the use of nonpharmacologic and pharmacologic therapies for OA. (16) The recommendations were classified as either “strong,” “conditional,” or “none.” ACR issued a conditional recommendation for the use of transcutaneous electrical stimulation for the treatment of OA of the knee. This recommendation should only be considered for patients with chronic moderate or severe pain who are candidates for total knee arthroplasty, but who are unwilling or unable to undergo the procedure due to comorbidities or concomitant use of medications that are contraindications to surgery or are advised against the procedure by a surgeon. Updated guidelines are expected in 2019.

In 2015, ACR published recommendations for the treatment of rheumatoid arthritis. (17) All recommended treatments were pharmacologic. Use of electrical stimulation for treating rheumatoid arthritis was not addressed.

Summary of Evidence

For individuals who have arthritis who receive pulsed electrical or electromagnetic stimulation, the evidence includes several small randomized controlled trials (RCTs). Relevant outcomes are symptoms, functional outcomes, health status measures, and treatment-related morbidity. A review of the literature did not find adequate evidence that use of pulsed electrical or electromagnetic stimulation for the treatment of arthritis improves health outcomes. A 2013 meta-analysis identified 9 randomized sham-controlled trials on treatment of OA of the knee. There was some evidence of improved function but no evidence of reduced pain. These conclusions are limited by methodologic shortcomings and inconsistent trial results. More recent RCTs have also had variable results, which might be related to the different devices and treatment durations used. Additional studies with larger numbers of subjects are needed.

The evidence is insufficient to determine the effects of the technology on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

97014

HCPCS Codes

E0762

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

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 meta- analysis. 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. 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

6. 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

7. Farr J, Mont MA, Garland D, et al. Pulsed electrical stimulation in patients with osteoarthritis of the knee: follow up in 288 patients who had failed non-operative therapy. Surg Technol Int. 2006; 15:227-233. PMID 17029181

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

9. Wuschech H, von Hehn U, Mikus E, et al. 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

10. 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

11. 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

12. Dundar U, Asik G, Ulasli AM, et al. 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

13. 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

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

15. American Academy of Orthopaedic Surgeons. Treatment of osteoarthritis of the knee. 2013; Available at <http://www.aaos.org> (accessed June 16, 2017).

16. Hochberg MC, Altman RD, April KT, et al. 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

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

18. Electrical Stimulation for the Treatment of Arthritis. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (March 2017) Durable Medical Equipment 1.01.27.

Policy History:

Date Reason
6/15/2018 Reviewed. No changes.
10/15/2017 Document updated with literature review. The following was added to Coverage: “or electromagnetic stimulation”.
8/1/2016 Document updated with literature review. Coverage unchanged.
5/1/2015 Reviewed. No changes.
6/1/2014 New medical document. Coverage is unchanged: Electrical stimulation is considered experimental, investigational and/or unproven for the treatment of osteoarthritis or rheumatoid arthritis. This topic was previously addressed on MED201.026 Surface Electrical Stimulation.

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