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.

Note: Biofeedback as a treatment of headache is addressed in a separate policy, No. 2.01.29, while biofeedback as a treatment of fecal incontinence, urinary incontinence and other miscellaneous applications is addressed in policy No. 2.01.64, 2.01.27, and 2.01.53, respectively.

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

BlueCard/National Account Issues

In many Plans, biofeedback is contractually excluded. If contractually excluded in the host Plan, but not in the home Plan, the host Plan may use this policy as the basis of coverage decisions for the home Plan.

Biofeedback may be offered as part of a comprehensive program in pain management as offered by pain management centers.

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.” (1) 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 is based on a 1996 TEC Assessment (2), 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. (3) 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. (4, 5) 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. (6) 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. (7) 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 (9) 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. (10) 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). (11) 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. (12)

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. (13) 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). (14) 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 (15) 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. (16) 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.

Medicare Coverage

Biofeedback therapy is covered under Medicare only when it is reasonable and necessary for the individual patient for muscle re-education of specific muscle groups or for treating pathological muscle abnormalities of spasticity, incapacitating muscle spasm, or weakness, and more conventional treatments (heat, cold, massage, exercise, support) have not been successful. This therapy is not covered for treatment of ordinary muscle tension states or for psychosomatic conditions.

References:

1. 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.
2. 1996 TEC Assessments, Tab 25
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Babu AS, Mathew E, Danda D et al. Management of patients with fibromyalgia using biofeedback: a randomized control trial. Indian J Med Sci 2007; 61(8):455-61.
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. Weydert JA, Ball TM, Davis MF. Systematic review of treatments for recurrent abdominal pain. Pediatrics 2003; 111(1):e1-11.
11. Medlicott 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
12. McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006; 86(5):710-25.
13. 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.
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. 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.
16. 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.

Biofeedback as a Treatment of Chronic Pain
Biofeedback, Chronic Pain
EMG Biofeedback