Allied Health - Biofeedback as a Treatment of Chronic Pain

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

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. 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. Other 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.

Note: Biofeedback as a treatment of conditions other than chronic pain is addressed in separate policies listed in the Cross Reference section of this policy.

Policy/Criteria

Biofeedback as a treatment of chronic pain, including but not limited to low back pain, is considered investigational.

Scientific Background

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." (2) 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 their 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 is based on a 1996 TEC Assessment (3), 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.

A variety of randomized, controlled clinical trials have been published that have attempted to isolate the contribution of biofeedback in the treatment of chronic pain. The largest study of biofeedback in the treatment of lower back pain was published by Bush and colleagues who randomized 62 patients to receive either EMG biofeedback, sham biofeedback, or a no treatment control. (4) 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. (5,6)

Among controlled studies appearing between 1996 and 2002, new trials on low back pain are lacking. A study by Buckelew and colleagues addressed fibromyalgia. (7) A total of 119 patients 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. Dursun and colleagues randomized 60 patients with knee pain to either EMG biofeedback plus conventional exercise or conventional exercise alone. (8) There were no differences between groups on pain or function. Humphreys and Gevirtz randomly assigned 64 patients to groups treated with: increased dietary fiber; fiber and biofeedback; fiber, biofeedback, and cognitive-behavioral therapy; and fiber, biofeedback, cognitive-behavioral therapy, and parental support. (9) The 3 multi-component treatment groups were similar and had better pain reduction than the fiber-only group. This study does not address placebo effects. A randomized study by Bergeron of 78 patients with vulvar vestibulitis compared biofeedback, surgery and cognitive-behavioral therapy. (10) Surgery patients had significantly better pain scores than patients who received biofeedback or cognitive-behavioral therapy. No placebo treatment was used.

In a randomized clinical trial of 143 females with fibromyalgia, van Santen and colleagues compared biofeedback and fitness training to usual care. (11) The primary outcome evaluated was pain using a visual analogue scale. The authors reported there were no clear improvements in objective or subjective patient outcomes with biofeedback (or fitness training) over usual care.

In a meta-analysis of psychological interventions for rheumatoid arthritis including relaxation, biofeedback, and cognitive-behavioral therapy, Astin and colleagues concluded that psychological interventions may be important adjunctive therapies in rheumatoid arthritis treatment. (12) 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 could not be isolated.

In a systematic review of recurrent abdominal pain therapies in children, Weydert and colleagues concluded that behavioral interventions (cognitive-behavioral therapy and biofeedback) had a general positive effect on nonspecific recurrent abdominal pain and were safe. (13) However, as in the Astin meta-analysis, the specific effects of biofeedback were not isolated in this systematic review. Finally, in a randomized controlled trial of 92 patients with systemic lupus erythematosus (SLE), Greco and colleagues reported that patients treated with six sessions of biofeedback-assisted cognitive-behavioral treatment for stress reduction had a statistically significant greater improvement in pain post treatment than a symptom-monitoring support group (p=0.044) and a usual care group (p=0.028). (14) However, these improvements in pain were not sustained at nine month follow-up and further studies are needed to determine the incremental benefits of biofeedback-assisted cognitive-behavioral treatment over other interventions in SLE patients.

In a systematic review of therapies for temporomandibular joint (TMJ) disorders including exercise, electrotherapy and biofeedback, Medlicott and colleagues recommended caution in interpreting results due to heterogeneity in study design and interventions used. (15) Since biofeedback was not isolated from other therapies, no conclusions could be reached for biofeedback alone. McNeely and colleagues also conducted a systematic review.  Based on two poor-quality randomized controlled trials, the authors concluded 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. (16) Due to the lack of randomized controlled trials, questions remain concerning the contribution of biofeedback to improvements in health outcomes.

An updated search of the MEDLINE database through July 25, 2007 returned no clinical trials that alter the conclusions reached above.

References

1. BlueCross BlueShield Association Medical Policy Reference Manual; Policy No. 2.01.30
2. NIH Technology Assessment Panel. 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
3. TEC Assessment: Biofeedback, 1996; BlueCross and BlueShield Association Technology Evaluation Center. Vol. 10, Tab 25
4. Bush C, Ditto B, Feuerstein M. A controlled evaluation of paraspinal EMG biofeedback in the treatment of chronic low back pain. Health Psychol 1985;4(4):307-21
5. Stuckey SJ, Jacobs A, Goldfarb J. EMG biofeedback training, relaxation training, and placebo for the relief of chronic back pain. Percept Mot Skills 1986;63(3):1023-36
6. Flor H, Haag G, Turk DC et al. Efficacy of EMG biofeedback, pseudotherapy, and conventional medical treatment for chronic rheumatic back pain. Pain 1983;17(1):21-31
7. Buckelew SP, Conway R, Parker J et al. Biofeedback/relaxation training and exercise interventions for fibromyalgia: a prospective trial. Arthritis Care Res 1998;11(3):196-209
8. Dursun N, Dursun E, Kilic Z. Electromyographic biofeedback-controlled exercise versus conservative care for patellofemoral pain syndrome. Arch Phys Med Rehabil 2001; 82(12):1692-5
9. Humphreys PA, Gevirtz RN. Treatment of recurrent abdominal pain: components analysis of four treatment protocols. J Pediatr Gastroenterol Nutr 2000;31(1):47-51
10. Bergeron S, Binik YM, Khalife S et al. 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
11. van Santen M, Bolwijn P, Verstappen F et al. A randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia. J Rheumatol 2002;29(3):575-81
12. Astin JA, Beckner W, Soeken K et al. Psychological interventions for rheumatoid arthritis: a meta-analysis of randomized controlled trials. Arthritis Rheum 2002;47(3):291-302
13. Weydert JA, Ball TM, Davis MF. Systematic review of treatments for recurrent abdominal pain. Pediatrics 2003;111(1):e1-11
14. Greco CM, Rudy TE, Manzi S. 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
15. Medicott MS, Harris SR. 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
16. McNeely ML, Armijo OS, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther 2006;86(5):710-25

Cross References

Biofeedback as a Treatment of Urinary Incontinence in Adults, Regence Medical Policy Manual, Allied Health, Policy No. 26

Biofeedback as a Treatment of Headache, Regence Medical Policy Manual, Allied Health, Policy No. 27

Biofeedback for Miscellaneous Indications, Regence Medical Policy Manual, Allied Health, Policy No. 29

Biofeedback as a Treatment of Fecal Incontinence, TRG Medical Policy Manual, Allied Health, Policy No. 30

Neurofeedback, Regence Medical Policy Manual, Medicine, Policy No. 65

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