Subject:
Electrical and Electromagnetic Stimulation for the Treatment of Arthritis
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Pulsed electrical and electromagnetic stimulation are being investigated to improve functional status and relieve pain related to osteoarthritis and rheumatoid arthritis that is unresponsive to other standard therapies. Electrical stimulation is provided using a device that noninvasively delivers a subsensory low-voltage, monophasic electrical field to the target site of pain. Pulsed electromagnetic fields are delivered using coils placed over the skin.
Populations | Interventions | Comparators | Outcomes |
Individuals:
· With arthritis | Interventions of interest are:
· Pulsed electrical or electromagnetic stimulation | Comparators of interest are:
· Pharmacologic therapy
· Physical therapy | Relevant outcomes include:
· Symptoms
· Functional outcomes
· Health status measures
· Treatment-related morbidity |
Background
Electrical and electromagnetic stimulation are being investigated to improve functional status and to relieve pain related to osteoarthritis 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 or 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 (see 'Electrical Bone Growth Stimulation of the Appendicular Skeleton' (Policy #010 in the Treatment Section).
Regulatory Status
The BioniCare Bio-1000™ stimulator (VQ OrthoCare) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process to deliver pulsed electrical stimulation for adjunctive treatment of osteoarthritis of the knee and rheumatoid arthritis of the hand. The FDA determined that this device was substantially equivalent to transcutaneous electrical nerve stimulation 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 short-wave 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 osteoarthritis 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.
Related Policies
- Electrotherapies in Pain Management (Policy #025 in the Treatment Section)
- Electrical Bone Growth Stimulation of the Appendicular Skeleton (Policy #010 in the Treatment Section)
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Electrical or electromagnetic stimulation is considered investigational for the treatment of osteoarthritis or rheumatoid arthritis.
Medicare Coverage:
Per Noridian Healthcare Services, LLC, LCD L34821, there is insufficient published clinical evidence to establish that treatment with TEJSD (HCPCS code E0762) and with other electro-magnetic devices such as transcutaneous electrical stimulation devices (TENS), neuromuscular stimulators (NMES), functional electrical stimulators (FES), singly or in any combination, meet the requirements to be considered reasonable and necessary for the treatment of osteoarthritis. Therefore, these devices are noncovered.
For additional information, refer to Local Coverage Determination (LCD): Transcutaneous Electrical Joint Stimulation Devices (TEJSD) (L34821). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=1&bc=AAgAAAAAAAAA&#aFinal.
For information on electric stimulation in pain management, refer to Policy #025 Electrotherapies in Pain Management (in the Treatment Section).
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[RATIONALE: This policy was created in 2010 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through January 6, 2019.
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.
To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice. The following is a summary of the key literature to date.
Clinical Context and Therapy Purpose
The purpose of pulsed electrical or electromagnetic stimulation is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as pharmacological therapy and physical therapy, in patients with arthritis.
The question addressed in this policy is: does the use of pulsed electrical or electromagnetic stimulation improve health outcomes in patients with pain related to osteoarthritis (OA) and rheumatoid arthritis?
The following PICOTS were used to select literature to inform this review.
Patients
The relevant population of interest are individuals with OA and rheumatoid arthritis.
Interventions
The therapy being considered is pulsed electrical or electromagnetic stimulation. The various forms of stimulation involved in this type of therapy include pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads or 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.
Comparators
Comparators of interest include pharmacological therapy and physical therapy. Treatment for arthritis includes physical exercise, self-care, NSAIDs, topical analgesics, and surgical interventions.
Outcomes
The general outcomes of interest are symptoms, functional outcomes, health status measures, and treatment-related morbidity.
Timing
The existing literature evaluating pulsed electrical or electromagnetic stimulation as a treatment for arthritis has varying lengths of follow-up as long as one year. While studies described below all reported at least one outcome of interest, 6-12 months duration of follow-up is desirable to assess outcomes.
Setting
Patients with arthritis are actively managed by physical therapists, orthopedic surgeons, and primary care providers in an outpatient clinical setting.
Study Selection Criteria
Methodologically credible studies were selected using the following principles:
a. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
b. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
c. To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
Studies with duplicative or overlapping populations were excluded.
Systematic Reviews
Two systematic reviews have reached somewhat different conclusions on the use of electric and electromagnetic field stimulation for treating kneeOA.
A systematic review by Negm et al (2013), which included 7 small, sham-controlled randomized trials (total n=459 patients), examined pulsed electrical stimulation (PES) and pulsed electromagnetic field (PEMF) for the treatment of knee 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 (2011),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 around estimates) due to small samples sizes.
A 2013 Cochrane review of PES and PEMF included 9 studies (totaln=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% confidence intervals, 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 three studies. For all nine 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.2,4,5,6,7,8,9,10,11,12,13,
Section Summary: Electric Stimulation Therapies for OA of the Knee.
Results from two systematic reviews have reached somewhat different conclusions on use of electric and electromagnetic field stimulation for treating knee OA. In both reviews, there was no significant difference between active and sham groups for at least one outcome of interest. Both studies had a high-risk of bias as well as inadequacies in reporting and validity. Overall, the evidence is insufficient that use of electrical stimulation therapies improve health outcomes.
Pulsed Electrical Stimulation (BioniCare)
Randomized Controlled Trials
Fary et al (2011) reported on 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 three 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 scores.
Garland et al (2007) reported a randomized, double-blind, sham-controlled study of the BioniCare device for 58 patients with OA of the knee.4, Due to protocol violations from one of the centers (other new treatments were provided during the study), 42 subjects were excluded from the analysis. At the end of three months of use, improvements in pain and WOMAC scores were statistically significantly greater in the active device group than in the sham group.
Zizic et al (1995) reported on a 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 that of 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 four weeks of treatment included patient assessment of pain and function and physician global evaluation of the patient's condition. Trialists reported the BioniCare group had statistically significant improvement (defined as improvement ≥50%) compared with the sham group for each of the primary outcomes assessed.
Nonrandomized Controlled Trials
Mont et al (2006) reported 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 matched (age, sex, weight) historical 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
VQ OrthoCare (2006) 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 the patients' condition. In addition, 45.4% reduced their use of NSAIDs by 50% or more. However, this study did not include a randomized control group.
Section Summary: PES (BioniCare)
Two RCTs evaluated PES for pain relief and functional improvement in OA compared with a sham. Analysis marginally favored PES over placebo. Both trials utilized a sham that turned off automatically. A nonrandomized controlled trial compared time to requirement of TKA in OA patients who had PES compared to an untreated historical control. Deferral of TKA in the intervention group is difficult to interpret. One uncontrolled trial had promising results and reported patients with OA of the knee who were treated with the device had experienced improvements in several clinical areas and reduced their use of NSAIDs by nearly 50%.
Pulsed Electromagnetic Stimulation
The literature on PEMF consists primarily of small sample size RCTs using a variety of devices and ranges of treatment times (10 minutes to 12 hours). Most studies were conducted outside of the United States.
PEMF vs Sham PEMF
Bagnato et al (2016) reported on 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 the36-ItemShort-Form Health Survey physical scores.
Wuschech et al (2015) evaluated use of 10 minutes of 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
Nelson et al (2013) reported on 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 four or more, only patients who had at least two 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. By 6 months, the maximum recorded VAS 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.
Fukuda et al (2011) 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 one-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 the Knee Osteoarthritis Outcome Score subscale scores. The percentages of patients who attained the minimal clinically important difference of 2 points on the numeric rating scale 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 one-year follow-up, larger improvements in the Knee Osteoarthritis Outcome Score subscales were maintained by patients in the PEMF groups. 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.
PEMF Plus Physical Therapy vs Sham PEMF Plus Physical Therapy
Dundar et al (2016) reported a double-blind, sham-controlled randomized trial of 40 patients with knee OA that evaluated 20 minutes of PEMF plus 1 hour of physical therapy, and 20 minutes of sham PEMF plus 1 hour of physical therapy.12, Both groups-PEMF (PMT Quattro PRO; ASA) plus physical therapy and sham PEMF plus physical therapy-showed equally significant reductions in pain scores.
Ozguclu et al (2010) reported a double-blind RCT from Turkey investigating 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 two weeks, both groups showed reductions in pain and improvements in function scores on the WOMAC but between-group differences were not statistically significant.
Section Summary: PEMF plus Physical Therapy vs Sham PEMF plus Physical Therapy
The results from both randomized trials investigation of the effect of PEMF plus physical therapy on patients with OA of the knee found that PEMF as an adjuvant had no incremental benefit for reduction in pain or statistically significant benefit in stiffness, and disability in patients. Both studies had short follow-up windows and long-term benefit of continued therapy cannot be ascertained at this time. Studies with longer periods of follow-up are needed to evaluate the efficacy of PEMF therapy for OA of the knee.
Summary of Evidence
For individuals who have arthritis who receive pulsed electrical or electromagnetic stimulation, the evidence includes a number of small RCTs. The 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.
SUPPLEMENTAL INFORMATION
Practice Guidelines and Position Statements
Osteoarthritis Research Society International
The Osteoarthritis Research Society International (2014) published evidence-based consensus guidelines for nonsurgical management of knee osteoarthritis (OA).14, Twenty-nine treatment modalities were evaluated for four patient groups: knee-only OA, knee-only OA with comorbidities, multijoint OA, and multijoint OA with comorbidities. Neuromuscular electrical stimulation was considered "not appropriate" for all four 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
The American Academy of Orthopaedic Surgeons (2013) published guidelines on the treatment of OA of the knee.15, Due to the overall inconsistent finding for electrotherapeutic modalities, the Academy did not recommend for or against use in patients with symptomatic knee OA. The strength of the recommendation was inconclusive.
American College of Rheumatology
The American College of Rheumatology published recommendations on the use of nonpharmacologic and pharmacologic therapies for OA.16, The recommendations were classified as either "strong," "conditional," or "none." The College 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 2018.
The College (2015) released recommendations for the treatment of rheumatoid arthritis.17, All recommended treatments were pharmacologic. Use of electrical stimulation for treating rheumatoid arthritis was not addressed. Updated guidelines are expected in 2019 or early 2020.
U.S. Preventive Services Task Force Recommendations
Not applicable.
Ongoing and Unpublished Clinical Trials
Currently ongoing and unpublished trials that may influence this review are listed in Table 1.
Table 1. Summary of Key Trials
NCT No. | Trial Name | Planned Enrollment | Completion Date |
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 | Dec 2018 |
Unpublished |  |  |  |
NCT01838954 | The Effect of Short-wave Diathermy in Patients with Osteoarthritis of the Hand: A Randomized, Double Blinded, Placebo Controlled Trial | 90 | Apr 2016
(unknown) |
NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Electrical and Electromagnetic Stimulation for the Treatment of Arthritis
Electrical Stimulation for the Treatment of Arthritis
BioniCare Bio-1000 Stimulator
Pulsed Electrical Stimulation, BioniCare Bio-1000
OrthoCor™ Active Knee System
SofPulse™
Ivivi Torino II™
Palermo
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. Dec 14 2013;12(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. Oct 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; http://www.aaos.org/research/guidelines/guidelineoaknee.asp. Accessed February 1, 2018.
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
Codes:
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CPT*
HCPCS
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
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