Coverage Policy Manual
Policy #: 2009027
Category: Medicine
Initiated: August 2009
Last Review: April 2018
  Biofeedback as a Treatment of Chronic Pain

Description:
Treatment for chronic pain is often multimodal, and typically includes a component of behavioral therapy. Behavior techniques vary, but are geared toward reducing muscle tension to break the pain cycle. Behavioral therapies include a variety of relaxation techniques, such as meditation, mental imagery, and cognitive therapy, which teaches subjects the ability to cope with stressful stimuli by attempting to alter negative thought and dysfunctional attitudes. Relaxation exercises may be part of the coping skills taught with cognitive-behavioral therapy. Electromyography (EMG) biofeedback has been used as part of a behavioral treatment program, with the assumption that the ability to reduce muscle tension will be improved through feedback of data regarding degree of muscle tension to the subject.
 
Generally, biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. The technique involves the feedback of a variety of types of information not normally available to the patient, followed by a concerted effort on the part of the patient to use this feedback to help alter the physiological process in some specific way. Biofeedback training is done either in individual or group sessions, alone, or in combination with other behavioral therapies designed to teach relaxation. A typical program consists of 10 to 20 training sessions of 30 minutes each. Training sessions are performed in a quiet, non-arousing environment. Subjects are instructed to use mental techniques to affect the physiologic variable monitored, and feedback is provided for successful alteration of that physiologic parameter. The feedback may be in the form of lights or tone, verbal praise, or other auditory or visual stimuli.
 
Regulatory Status
A large number of biofeedback devices have received FDA clearance through the 510(k) process since
1976. FDA product code: HCC

Policy/
Coverage:
Biofeedback for any condition is an exclusion in the member certificate of coverage in most member benefit certificates.
 
For member benefit certificates without this specific contract exclusion, biofeedback as a treatment of chronic pain, including but not limited to low back pain, is investigational.  Investigational services are not covered.
 

Rationale:
Current approaches to treatment of chronic pain are multidisciplinary. Behavioral and psychological interventions are now a standard component of therapy in the majority of centers treating chronic pain in the United States. Among behavioral, i.e., non-drug approaches to pain management, a variety of options are available in addition to biofeedback. Relaxation techniques are similar to biofeedback in that the intent of each is to teach the subject to break the pain/spasm cycle by reducing muscle tension.
 
Behavioral treatments involve both nonspecific and specific therapeutic effects. Nonspecific effects, sometimes called placebo effects, occur as a result of therapist contact, positive expectancies on the part of the subject and the therapist, and other beneficial effects that occur as a result of being a patient in a therapeutic environment. Specific effects are those that occur only because of the active treatment, above any nonspecific effects that may be present. Because an ideal placebo control is problematic with behavioral treatments, and because treatment of chronic pain is typically multimodal, isolating the specific contribution of biofeedback is difficult.
 
The National Institutes of Health (NIH) convened a technology assessment panel in 1996, entitled “Integration of Behavior and Relaxation Approaches into the Treatment of Chronic Pain and Insomnia.”  The panel reviewed a variety of behavioral interventions in addition to biofeedback, including relaxation, hypnosis, and cognitive-behavioral therapy. For biofeedback, the panel concluded that the evidence is moderate for the effectiveness of biofeedback in treating a variety of types of pain. The statement did not discuss in depth the independent contribution of the feedback component beyond that of relaxation alone. In the summary conclusion on treating chronic pain, the assessment stated that “Although relatively good evidence exists for the efficacy of several behavioral and relaxation interventions in the treatment of chronic pain, the data are insufficient to conclude that one technique is usually more effective than another for a given condition.”
 
This policy was originally based on a 1996 TEC Assessment, which concluded that evidence was insufficient to demonstrate the effectiveness of biofeedback for treatment of chronic pain. The available evidence did not clearly show whether biofeedback’s effects exceeded nonspecific placebo effects. It was also unclear whether biofeedback added to the effectiveness of relaxation training alone.
 
Lower Back Pain
The largest study of biofeedback in the treatment of lower back pain was published by Bush and colleagues who randomized 62 patients to either EMG biofeedback, sham biofeedback, or a no treatment control group.  At the conclusion of the trial, all 3 groups showed significant improvement in multiple measures of pain. There were no significant effects found for treatment type, leading the authors to conclude that biofeedback is not superior to placebo in controlling chronic pain. Two smaller controlled trials (24 patients in each trial) of biofeedback for low back pain reported conflicting results.  Controlled trials on low back pain after 1996 are lacking.
 
Fibromyalgia
Buckelew et al assessed the use of biofeedback for fibromyalgia with a total of 119 patients who were randomly assigned to 1 of 4 treatment groups: 1) biofeedback/relaxation, 2) exercise training, 3) combination treatment, and 4) an educational/attention control program.  While the combination treatment group had better tender point index scores than other treatment groups, this study does not address placebo effects or the impact of adding biofeedback to relaxation therapy. In a randomized clinical trial of 143 females with fibromyalgia, biofeedback and fitness training were compared to usual care by van Santen and colleagues.  The primary outcome evaluated was pain using a visual analogue scale. The authors reported no clear improvements in objective or subjective patient outcomes with biofeedback (or fitness training) over usual care. A small double-blinded randomized trial from Asia compared actual and sham biofeedback on pain, fitness, function, and tender points in 30 patients with fibromyalgia. (8) There was a trend for greater improvement in the active biofeedback group, but only the number of tender points (change of 8.6 active vs. 4.4 sham) was significantly different between the groups. The authors calculated that a sample size of 15 patients could detect a difference of 5 cm (10 cm max) on a visual analogue scale, suggesting that the study lacked adequate power. This study did not address biofeedback–assisted relaxation in comparison with relaxation training alone.
 
Abdominal Pain
Humphreys and Gevirtz randomly assigned 64 patients to groups treated with increased dietary fiber; fiber and biofeedback; fiber, biofeedback, and cognitive-behavioral therapy; or fiber, biofeedback, cognitive-behavioral therapy, and parental support. The 3 multicomponent treatment groups were similar and had better pain reduction than the fiber-only group. This study does not address placebo effects. In a systematic review of recurrent abdominal pain therapies in children, Weydert and colleagues concluded that behavioral interventions (cognitive-behavioral therapy and biofeedback) have a general positive effect on nonspecific recurrent abdominal pain and are safe.  The specific effects of biofeedback were not isolated in this systematic review and cannot be assessed.
 
Temporomandibular Joint Syndrome
A systematic review of therapies for temporomandibular joint (TMJ) disorders grouped interventions into 3 categories (exercise, electrotherapy, and biofeedback).  Due to the heterogeneous and frequently multiple interventions used in the reviewed studies, no conclusions could be reached for biofeedback alone without other relaxation techniques. Another systematic review concluded (from 2 low-quality randomized controlled trials) that biofeedback did not reduce pain more than relaxation or occlusal splint therapy for TMJ, but did improve oral opening when compared with occlusal splints.  
 
Rheumatoid Arthritis
In a meta-analysis of psychological interventions for rheumatoid arthritis including relaxation, biofeedback, and cognitive-behavioral therapy, Astin and colleagues found psychological interventions may be important adjunctive therapies in rheumatoid arthritis treatment.  In the 25 studies analyzed, significant pooled effect sizes were found for pain after an intervention. However, the same effect was not seen long term, and the meta-analysis did not isolate biofeedback from other psychological interventions. Therefore, the specific effects of biofeedback cannot be isolated.
 
Systemic Lupus
In a randomized controlled trial of 92 patients with systemic lupus erythematosus (SLE), Greco and colleagues found patients treated with 6 sessions of biofeedback-assisted cognitive-behavioral treatment for stress-reduction had statistically significant greater improvements in pain post-treatment than a symptom-monitoring support group (p=0.044) and a usual care group (p=0.028).  However, these improvements in pain were not sustained at 9 months’ follow-up, and further studies are needed to determine the incremental benefits of biofeedback-assisted cognitive-behavioral treatment over other interventions in patients with SLE.
 
Knee Pain
Dursun et al randomized 60 patients with knee pain to either EMG biofeedback plus conventional exercise or conventional exercise alone. There were no differences between groups on pain or function.
 
Vulvar vestibulitis
A randomized study by Bergeron of 78 patients with vulvar vestibulitis compared biofeedback, surgery, and cognitive-behavioral therapy.  Patients who underwent surgery had significantly better pain scores than patients who received biofeedback or cognitive-behavioral therapy. No placebo treatment was used.
 
In summary, relaxation training with biofeedback has been investigated as a treatment for a variety of chronic pain conditions. However, there is a lack of randomized controlled trials in this area, and questions remain about the contribution of biofeedback over relaxation training alone. The scientific evidence available at this time does not permit conclusions regarding the effect of this technology on health outcomes. Therefore, the policy statement is unchanged.
 
2011 Update
Biofeedback remains a contract exclusion in most member benefit certificates of coverage.  This policy is maintained for those contracts where biofeedback is not an exclusion.  A literature search was conducted in which no new literature was identified that would prompt a change in the coverage statement. A summary of the key identified literature is included below.
 
A 2010 Cochrane review on behavioral treatments for chronic low-back pain included a meta-analysis of 3 small randomized trials comparing electromyography (EMG) biofeedback to a waiting-list control group (Henschke, 2010).  In the pooled analysis, there were a total of 34 patients in the intervention group and 30 patients in the control group. The standard mean difference in short-term pain was -0.80 (95% confidence interval [CI]:-1.32 to -0.28); this difference was statistically significant favoring the biofeedback group. The Cochrane review did not conduct meta-analyses of trials comparing biofeedback to sham biofeedback and therefore did not control for any non-specific effects of treatment.
 
In 2010, Kapitza and colleagues compared the efficacy of respiratory biofeedback to sham biofeedback in 42 patients with lower back pain (Kapitza, 2010).  All participants were instructed to perform daily breathing exercises with a portable respiratory feedback machine; exercises were performed for 30 minutes on 15 consecutive days. Patients were randomized to an intervention group that received visual and auditory feedback of their breathing exercises or a control group that received a proxy signal imitating breathing biofeedback. Patients recorded pain levels in a diary 3 times a day, measuring pain on a visual analogue scale (VAS). Both groups showed reduction in pain levels at the end of the intervention period and at the 3 month follow-up, but there were no significant differences in pain between groups. For example, the mean change in pain with activity 3 months after the intervention was a reduction in 1.12 points on a 10-point VAS scale in the intervention group and 0.96 points in the sham control group; p>0.05. The mean change in pain at rest after 3 months was a reduction of 0.79 points in the intervention group and 0.49 points in the control group; p>0.05.
 
Finally, a small RCT (40 patients) assessed whether the addition of biofeedback to strengthening exercises improved outcomes in patients with osteoarthritis; no differences between the 2 treatment conditions were found (Yilmaz, 2010).
 
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below
 
In 2013, Glombiewski et al published a meta-analysis of studies on the efficacy of EMG and EEG biofeedback (ie, neurofeedback) for treating patients with fibromyalgia (Globiewski, 2013). The authors identified 7 RCTs comparing biofeedback with a control condition in patients with fibromyalgia syndrome. Studies in which biofeedback was evaluated only as part of multicomponent interventions were excluded from the review. Three studies used EEG biofeedback and 4 used EMG biofeedback; there were a total of 321 patients. A sham intervention was used as a control condition in 4 studies, 2 using EEG biofeedback and 2 using EMG- biofeedback. In a pooled analysis of the studies using EMG biofeedback, biofeedback significantly reduced pain intensity compared with a comparison intervention (effect size, Hedges g, 0.86; 95% CI, 0.11 to 0.62). A pooled analysis of studies on EEG biofeedback did not find a significant benefit compared with control conditions. Pooled analyses of studies of EMG and EEG biofeedback did not find a significant benefit of the intervention on other outcomes including sleep problems, depression and health-related quality of life. None of the studies included in this review were high quality, with risk of bias assigned by the authors as either unclear or high for all included studies. In addition, all of the studies reported on short-term outcomes, resulting in a lack of evidence on whether longer-term outcomes are improved. (For more information on EEG-biofeedback, see Policy 1998044.)
 
A 2011 guideline by the American College of Occupational and Environmental Medicine recommended biofeedback for “select patients with chronic low back pain as a component (not a separate procedure) of cognitive behavioral therapy (CBT) or as a procedure in the context of an interdisciplinary or functional rehabilitation program.” Biofeedback was not recommended for acute or subacute pack pain (ACEOM, 2011).
  
2015 Update
A literature search conducted through February 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Several trials with active comparison groups have not found that biofeedback is superior to alternative treatments. More recently, in 2015, Tan and colleagues evaluated 3 self-hypnosis interventions and included EMG biofeedback as a control intervention (Tan, 2015). The study enrolled 100 patients with chronic low back-pain. After the 8-week intervention, reported reductions in pain intensity were significantly higher in the hypnosis groups combined compared with the biofeedback group (p=0.042).
 
2016 Update
A literature search conducted using the MEDLINE database through March 2016 did not reveal any new information that would prompt a change in the coverage statement.  
 
2018 Update
A literature search conducted through March 2018 did not reveal any new information that would prompt a change in the coverage statement.

CPT/HCPCS:
90875Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 30 minutes
90876Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 45 minutes
90901Biofeedback training by any modality

References: American College of Occupational and Environmental Medicine (ACOEM).(2011) Low back disorders,. 2011. Available online at: www.guideline.gov. Last accessed February, 2014.

Astin JA, Beckner W, Soeken K et al.(2002) Psychological interventions for rheumatoid arthritis: a meta-analysis of randomized controlled trials. Arthritis Rheum 2002; 47(3):291-302.

Babu AS, Mathew E, Danda D et al.(2007) Management of patients with fibromyalgia using biofeedback: a randomized control trial. Indian J Med Sci 2007; 61(8):455-61.

Bergeron S, Binik YM, Khalife S et al.(2001) A randomized comparison of group cognitive-behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Pain 2001; 91(3):297-306.

Buckelew SP, Conway R, Parker J et al.(1998) Biofeedback/relaxation training and exercise interventions for fibromyalgia: a prospective trial. Arthritis Care Res 1998; 11(3):196-209.

Bush C, Ditto B, Feuerstein M.(1985) controlled evaluation of paraspinal EMG biofeedback in the treatment of chronic low back pain. Health Psychol 1985; 4(4):307-21.

Dursun N, Dursun E, Kilic Z.(2001) Electromyographic biofeedback-controlled exercise versus conservative care for patellofemoral pain syndrome. Arch Phys Med Rehabil 2001; 82(12):1692-5.

Flor H, Haag G, Turk DC et al.(1983) Efficacy of EMG biofeedback, pseudotherapy, and conventional medical treatment for chronic rheumatic back pain. Pain 1983; 17(1):21-31.

Glombiewski JA, Bernardy K, Hauser W.(2013) Efficacy of EMG- and EEG-Biofeedback in Fibromyalgia Syndrome: A Meta-Analysis and a Systematic Review of Randomized Controlled Trials. Evid Based Complement Alternat Med 2013; 2013:962741.

Glombiewski JA, Hartwich-Tersek J, Rief W.(2010) Two psychological interventions are effective in severely disabled, chronic back pain patients: a randomised controlled trial. Int J Behav Med 2010; 17(2)97-107.

Greco CM, Rudy TE, Manzi S.(2004) Effects of a stress-reduction program on psychological function, pain, and physical function of systemic lupus erythematosus patients: a randomized controlled trial. Arthritis Rheum 2004; 51(4):625-34.

Henschke N, Ostelo RW, van Tulder MW et al.(2010) Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev 2010; (7):CD002014. .

Humphreys PA, Gevirtz RN.(2000) Treatment of recurrent abdominal pain: components analysis of four treatment protocols. J Pediatr Gastroenterol Nutr 2000; 31(1):47-51.

Kapitza KP, Passie T, Bernateck M et al.(2010) First non-contingent respiratory biofeedback placebo versus contingent biofeedback in patients with chronic low back pain: A randomized double-blind trial. Appl Psychophysiol Biofeedback 2010; 35(3):207-17.

McNeely ML, Armijo Olivo S, Magee DJ.(2006) A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006; 86(5):710-25.

Medlicott MS, Harris SR.(2006) A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Phys Ther 2006; 86(7):955-73

NIH Technology Assessment Panel.(1996) Integration of behavioral and relaxation approaches into the treatment of chronic pain and insomnia. NIH Technology Assessment Panel on Integration of Behavioral and Relaxation Approaches into the Treatment of Chronic Pain and Insomnia. JAMA 1996; 276(4):313-8.

Palermo TM, Eccleston C, Lewandowski AS et al.(2010) Randomized controlled trials of psychological therapies for management of chronic pain in children and adolescents: an updated meta-analytic review. Pain 2010; 148(3):387-97.

Stuckey SJ, Jacobs A, Goldfarb J.(1986) EMG biofeedback training, relaxation training, and placebo for the relief of chronic back pain. Percept Mot Skills 1986; 63(3):1023-36.

Tan G, Rintala DH, Jensen MP, et al.(2015) A randomized controlled trial of hypnosis compared with biofeedback for adults with chronic low back pain. Eur J Pain. Feb 2015;19(2):271-280. PMID 24934738

van Santen M, Bolwijn P, Verstappen F et al.(2002) randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia. J Rheumatol 2002; 29(3):575-81.

Weydert JA, Ball TM, Davis MF.(2003) Systematic review of treatments for recurrent abdominal pain. Pediatrics 2003; 111(1):e1-11.

Yilmaz OO, Senocak O, Sahin E et al.(2010) Efficacy of EMG-biofeedback in knee osteoarthritis. Rheumatol Int 2010; 30(7):887-92.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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