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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/10:2012

Issue
10:2012

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

Sub-sensory pulsed electrical stimulation is one form of electrical stimulation. Pulsed electrical stimulation using surface electrodes is being evaluated for the treatment of arthritis.

Electrical stimulation has been used to improve functional status and relieve pain related to osteoarthritis and rheumatoid arthritis unresponsive to other standard therapies. Electrical stimulation is provided by an electronic device that noninvasively delivers a sub-sensory low-voltage, monophasic electrical field to the target site of pain. 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. The 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.

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.


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

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 (RCTs), ideally observed over an extended period of time, is needed to adequately assess electrical stimulation outcomes. The study selection criteria outlined in a 1996 TEC Assessment on transcutaneous electrical nerve stimulation (TENS), as follows, may be applied:

  • the study contains original empirical data;
  • the study design includes a treatment group and a control group;
  • the study reports on a health outcome relevant to the pain condition treated; and
  • the study uses a random assignment, control group design.

Literature Review

This policy has been updated periodically using the MEDLINE database. The most recent literature update was performed for the period of August 2011 through August 2012.

Randomized Controlled Trials

To date, 3 small RCTs with pulsed electrical stimulation have been identified.

In 1995, Zizic et al. reported 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. (1) Patients used the BioniCare or placebo device for 6–10 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 long-term studies are warranted. In addition to longer term studies, larger studies would also be beneficial. The Zizic et al. trial was included in a 2002 Cochrane review of electromagnetic fields for the treatment of osteoarthritis (2) that concluded there may be some benefit, but further studies are needed. The Cochrane review also noted that the Zizic et al. trial was rated as high-quality, but it did not describe the randomization process; it was funded by the manufacturer, and it did not focus on outcomes of clinical significance.

An industry-sponsored, randomized, double-blind sham-controlled study of the BioniCare pulsed electrical stimulation device for 58 patients with osteoarthritis of the knee was reported in 2007. (3) 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 Western Ontario and McMaster Universities Arthritis Index (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.

In 2011, Fary et al. reported results from a randomized double-blind sham-controlled trial of pulsed electrical stimulation in 70 patients with osteoarthritis of the knee. (4) The device used in this study was a commercially available TENS (transcutaneous electrical nerve stimulator) unit that was modified to provide pulsed electrical stimulation. Participants were instructed to apply the device for a minimum of 6 hours a day. In the placebo group, the device turned itself off after 3 minutes. After 26 weeks of treatment, 59% of patients using the active device and 36% of controls had achieved target usage based on patient-maintained logs. Intention-to-treat analysis showed a statistically significant 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 WOMAC pain, function, and stiffness scores, short-form 36 (SF-36) physical and mental component summary scores, patient's global assessment of disease activity, or activity measures.

Data on treatment of rheumatoid arthritis of the hand using the BioniCare device were presented to the American College of Rheumatology in November 2005. (5) 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 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.

Non-randomized Controlled Trials

Reported in 2006 was a non-randomized study of pulsed electrical stimulation in 157 patients (recruited from 23 centers) with moderate to severe knee osteoarthritis who had received a recommendation for total knee arthroplasty (TKA). (6) Patients were instructed to use the electrical stimulation device for 6 to 10 hours per day. The time to TKA was compared to a historical matched (age, gender, and weight) control group of 101 knee osteoarthritis 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 osteoarthritis who were candidates for TKA were described in a poster presentation at the 2004 American Academy of Orthopaedic Surgeons’ annual meeting. (7) The poster presenters reported that patients using the BioniCare device avoided TKA over 50% of the time (p=0.0004) at 1-, 2-, 3-, and 4-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%).” 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 osteoarthritis treated with the BioniCare device in an open-label prospective study. (8) 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.

Summary

A review of the literature has not found adequate evidence to indicate the use of pulsed electrical stimulation for the treatment of arthritis will result in improvements in health outcomes. For osteoarthritis of the knee, 2 small published randomized controlled trials using the BioniCare device and 1 randomized trial with a customized device were identified. These trials have methodologic limitations and have reported mixed results. Short-term benefit was reported in the 2 BioniCare studies, but in the third trial that used a customized device and had the longest follow-up, pulsed electrical stimulation was no more effective than placebo at 26 weeks. No published studies of pulsed electrical stimulation for rheumatoid arthritis were identified.

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.

Medicare National Coverage

There is no national coverage decision. 

References:

  1. Zizic TM, Hoffman KC, Holt PA et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol 1995; 22(9):1757-61.
  2. Hulme J, Robinson V, DeBie R et al. Electromagnetic fields for the treatment of osteoarthritis. Cochrane Database Syst Rev 2002; (1):CD003523.
  3. 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 2007; 15(6):630-7.
  4. 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 2011; 63(5):1333-42.
  5. 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.
  6. Mont MA, Hungerford DS, Caldwell JR et al. Pulsed electrical stimulation to defer TKA in patients with knee osteoarthritis. Orthopedics 2006; 29(10):887-92.
  7. 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.
  8. 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; 15:227-33.

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 10/1/14)      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 10/1/14)     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