Coverage Policy Manual
Policy #: 2009026
Category: Medicine
Initiated: August 2009
Last Review: May 2018
  Biofeedback as a Treatment of Headache

Description:
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 the physiologic parameter. This feedback may be signals such as lights or tone, verbal praise, or other auditory or visual stimuli.
 
The various forms of biofeedback differ mainly in the nature of the disease or disorder under treatment, the biologic variable that the individual attempts to control, and the information that is fed back to the individual. Biofeedback techniques include peripheral skin temperature feedback, blood-volume-pulse feedback (vasoconstriction and dilation), vasoconstriction training (temporalis artery), and electromyographic (EMG) biofeedback; these may be used alone or in conjunction with other therapies (e.g., relaxation, behavioral management, medication). In general, EMG biofeedback is used to treat tension headaches. With this procedure electrodes are attached to the temporal muscles and the patient attempts to reduce muscle tension. Feedback on achievement of a decrease in muscle tension is provided to the individual, reinforcing those activities (behaviors or thoughts) that are effective. Thermal biofeedback is commonly used for migraine headaches. In this technique a temperature sensor is placed on the finger, and the subject is taught to increase peripheral vasodilation by providing feedback on skin temperature, an effect that is mediated through sympathetic activity. The pulse amplitude recorded from the superficial temporal artery has also been used to provide feedback. Temporal pulse amplitude biofeedback has been used to treat both chronic tension type headaches and migraine headaches.
 
A variety of biofeedback devices are cleared for marketing through the U. S. Food and Drug Administration (FDA) 510(k) process. These devices are designated by the FDA as class II with special controls and are exempt from the premarket notification requirements. The FDA defines a biofeedback device as “an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.”
 

Policy/
Coverage:
Effective, May 2010
 
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 meets member benefit certificate of coverage that there be scientific evidence of effectiveness in improving health outcomes as part of the overall treatment plan for migraine and tension-type headache.
 
For member benefit certificates without this specific contract exclusion, biofeedback for the treatment of cluster headaches and unsupervised home use of biofeedback for treatment of headaches does not meet member benefit certificate of coverage that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, biofeedback for the treatment of cluster headaches and unsupervised home use of biofeedback for treatment of headaches is considered investigational.  Investigational services are exclusions in most member benefit certificates of coverage.
 
Effective August 2009 - April 2010
 
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 may be considered medically necessary as part of the overall treatment plan for migraine and tension-type headache.
 
For member benefit certificates without this specific contract exclusion, unsupervised home use of biofeedback for treatment of headache is not medically necessary.
 

Rationale:
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 tension or migraine headaches. 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.
 
Between the 1996 TEC Assessment and policy update in 2002, controlled studies of biofeedback for headaches, using various types of relaxation therapy or no therapy as controls, reported conflicting results. The majority of studies did not support a benefit to biofeedback in terms of frequency and severity of headache symptoms. Negative studies suggested that there was no difference between the effects of biofeedback and other types of relaxation therapy alone. Studies reviewed in detail are described here.
 
Kroner-Herwig et al selected 50 pediatric patients with either tension headaches or combined tension-migraine headaches. Four treatment groups were created, based on combinations of the presence or absence of parental involvement in treatment and whether patients received either relaxation training or biofeedback. A waiting-list control group was also included. Several analytic approaches were used, one of which found biofeedback to have better effects on pain than relaxation. Another study by Bussone et al compared biofeedback-assisted relaxation training in adolescents with a control group, finding better pain improvement in the former group. Scharff et al enrolled 36 children and adolescents and randomized them to hand-warming biofeedback, to hand-cooling biofeedback, or to a waiting list. Patients treated with hand-warming biofeedback achieved greater degrees of clinical improvement than either of the other two groups. Hand-cooling biofeedback could be considered a placebo. Sartory et al randomly assigned 43 children to either relaxation training plus stress management, biofeedback plus stress management, or drug therapy with a beta-adrenergic blocking agent. Both the relaxation and biofeedback groups had better therapeutic outcomes than the drug therapy group.
 
Relaxation training was not considered to be an appropriate control for the non-specific effects of biofeedback. In addition, some studies indicated that the physiologic parameter "fed back" to the patient may not be related to the pathophysiology of headache. For example, Andrasik and Holroyd examined the correlation between success in controlling scalp muscle tension and the reduction in headache symptoms. Thirty patients with tension headaches were taught to either decrease, keep stable, or increase frontal muscle tension, but were all led to believe that they were decreasing muscle tone. Despite changes in muscle tone in the intended direction, the degree of headache relief was the same in all groups. In another similar study, patients who were told that they were successful at decreasing muscle tension, regardless of the actual results, achieved greater reduction in symptoms.  Similar results were reported in patients with migraine undergoing thermal biofeedback.
 
In 2007 and 2008, Nestoriuc and colleagues published systematic reviews of biofeedback for migraine and tension-type headaches. The meta-analysis for treatment of migraine included 55 studies (randomized, pre-post, and uncontrolled) and 39 controlled trials, reporting a medium effect size of 0.58 (pooled outcome of all available headache variables) for treatment of migraine. (9) Effect sizes were computed using Hedges’ g, which refers to the mean difference between the experimental and control groups divided by the pooled standard deviation. For treatment of tension-type headaches, 53 studies met criteria for analysis; these included controlled studies with standardized treatment outcomes, follow-up of at least 3 months, and at least 4 patients per treatment group.  Meta-analysis showed a medium-to-large effect size of 0.73 that appeared to be stable over 15 months of follow-up. Biofeedback was reported to be more effective than headache monitoring, placebo, and relaxation therapies. Biofeedback in combination with relaxation was more effective than biofeedback alone, and biofeedback alone was more effective than relaxation alone, suggesting different elements for the two therapies. Although these meta-analyses are limited by the inclusion of studies of poor methodological quality, the authors did not find evidence of an influence of study quality or publication bias in their findings.
 
Another meta-analysis assessed psychological treatments of recurrent tension headache or migraine in children.  Three studies were included that compared relaxation combined with biofeedback versus relaxation training alone. In general, small standardized effect sizes (0, 0.5, and 0.25) were reported from the 3 studies for the addition of biofeedback on headache symptoms (frequency, intensity, and duration of headache). Small standardized effect sizes were also reported for clinically significant changes (> 50% reduction) in headache symptoms (0.20, 0.34, and 0). A 2006 systematic review of non-pharmacological treatments for migraine concluded that the current literature does not show clear effectiveness of biofeedback for migraine in children.  
 
Martin et al compared cognitive behavioral therapy (CBT) versus temporal pulse amplitude (TPA) biofeedback (8 weekly sessions plus homework) or wait-list control among patients who volunteered for a study of psychological treatments.  Thirty patients with migraine and 21 with tension-type headaches were randomized to 1 of the 3 treatments; 51 completed the protocol (20% dropout) with no significant difference in loss to follow-up among the groups. Patient logs showed an average reduction in headaches of 68% for the CBT group, 56% for biofeedback, and 20% for the control condition. Clinically significant improvement, defined as at least 50% reduction in either headache rating or medication use, was observed in 78% of the CBT group, 63% of the biofeedback group, and 23% of the control group. The cognitive mediators (self-efficacy and locus of control) that had been hypothesized to underlie efficacy of both biofeedback and CBT were not found to be associated with improvement for either treatment. Statistical analysis was limited by the small group sizes.
 
Clinical Input Received through Physician Specialty Societies and Academic Medical Centers
In response to requests, input was received through 3 physician specialty societies and 3 academic medical centers (4 inputs) while this policy was under review. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. Clinical input considered biofeedback to be a reliable and appropriate nonpharmacologic option for treatment of headaches.
 
Based on clinical input, physician specialty society recommendations, and the evidence available at this time, biofeedback may be considered an appropriate technique to treat migraine and tension-type headaches. Biofeedback, along with other behavioral techniques such as relaxation training, may be particularly useful for children, pregnant women, and other adults who are not able to take medications.
 
Physician Specialty Society Guidelines
The National Institute of Neurologic Disorders and Stroke (2008) state that when headaches occur 3 or more times a month, preventive treatment is usually recommended.  “Drug therapy, biofeedback training, stress reduction, and elimination of certain foods from the diet are the most common methods of preventing and controlling migraine and other vascular headaches. Drug therapy for migraine is often combined with biofeedback and relaxation training.”
 
The American Academy of Family Physicians (AAFP) 2000 guidelines on preventive therapy for migraines, based on evidence review by the U.S. Headache Consortium, recommend relaxation training, thermal biofeedback combined with relaxation training, EMG biofeedback, and cognitive-behavioral therapy as treatment options for prevention of migraine (Grade A recommendation).  Relaxation techniques and biofeedback may be combined with preventative drug therapy to achieve additional clinical improvement (Grade B recommendation). According to the guidelines, nonpharmacologic therapy may be well suited for patients who have exhibited a poor tolerance or poor response to drug therapy, who have a medical contraindication to drug therapy, and who have a history of long-term, frequent or excessive use of analgesics or other acute medications. Nonpharmacologic intervention may also be useful in patients with significant stress or in patients who are pregnant, are planning to become pregnant, or are nursing.
 
The American Academy of Neurology’s (AAN) recommendations for the evaluation and treatment of migraine headaches states that behavioral and physical interventions are used for preventing migraine episodes rather than for alleviating symptoms once an attack has begun.  Although these modalities may be effective as monotherapy, they are more commonly used in conjunction with pharmacologic management. Relaxation training, thermal biofeedback combined with relaxation training, electromyographic biofeedback, and cognitive-behavioral therapy may be considered treatment options for prevention of migraine. Specific recommendations regarding which of these to use for specific patients cannot be made.
 
2010 Update
 
A search of the MEDLINE database was conducted which included an extensive search of the literature on the use of biofeedback for cluster headaches. Some older articles from the 1980’s were found but no recent studies were identified.  
 
Verhagen and colleagues published a systematic review of behavioral treatments for chronic tension-type headache in adults in 2009 (Verhagen, 2009). Eleven studies, including 2 studies with low risk of bias, compared biofeedback with waiting list conditions. Results were found to be inconsistent due to low power, leading the authors to conclude that larger and more methodologically robust studies should be performed.
 
A 2009 Cochrane review evaluated psychological therapies for the management of chronic and recurrent pain in children and adolescents (Eccleston, 2009) (Palermo 2010). Twenty-one randomized controlled trials met inclusion criteria for the analysis on headache, including 3 trials with biofeedback and relaxation training, and 3 trials with biofeedback and cognitive training. Clinically significant pain reduction was found for biofeedback (odds ratio of 23.34), but not for disability or emotional functioning. The authors concluded that psychological treatments (including biofeedback as part of a treatment regimen) are effective in pain control for children with headache, and the benefits appear to be maintained.
 
The evidence remains insufficient to evaluate the effect of biofeedback on cluster headaches.  
 
2012 Update
A search of the MEDLINE database was conducted through September 2012. There was no new information identified that would prompt a change in the coverage statement. One randomized controlled trial was identified. In 2010, Gerber et al. reported on a trial of a multi-modal behavioral training program (n=19) compared to the “benchmark” of biofeedback (n=15) in pediatric patients 7 to 16 years of age with recurrent migraine and/or tension-type headache (Gerber, 2010) .Patients with chronic daily headache (> 15 days per month) were excluded from the study. The multi-model behavioral educational group program included eight 90-minute sessions of training (diagnostic, educational, and behavioral) for the children and four 120-minute sessions for their parents. Children in the biofeedback group underwent electromyographic (EMG) and thermal biofeedback once per week for 20 sessions (total of 900 minutes of training). During treatment, 5 patients withdrew due to difficulty with adherence (4 from the biofeedback group). At 6 months, children’s diaries indicated a 47% decrease in the intensity of headaches after biofeedback but no significant difference in the frequency or duration of headaches. Diary results are limited by the low (40%) completion rate. Questionnaire results from parents and children indicated a decrease in headache duration, frequency, and intensity. Diaries of daily living activities and a pediatric quality-of-life questionnaire indicated that after treatment, the children were less disturbed by their headaches in the domains of school, homework, and leisure time. There were no significant differences between the treatments, although power analysis indicated that 50 patients per group would be needed to detect differences.
 
2014 Update
A literature search conducted through April 2014 did not reveal any new information that would prompt a change in the coverage statement   
 
2015 Update
A literature search conducted through April 2015 did not reveal any new information that would prompt a change in the coverage statement.
 
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
 
Biofeedback remains a contract exclusion in most member benefit certificates.
 
A literature search was conducted using the MEDLINE database. One new publication was identified. In 2016, Stubberud et al reported a meta-analysis of biofeedback as prophylaxis for pediatric migraine (Stubberud, 2016). They identified 5 RCTs (total N=137 children and adolescents) that met inclusion criteria. Meta-analysis found that biofeedback reduced migraine frequency (mean difference in attacks per week, -1.97, 95% confidence interval, -2.72 to -1.21; p<0.001), attack duration (mean difference, -3.94; 95% confidence interval, -5.57 to -2.31; p<0.001) and headache intensity (mean difference, -1.77 out of 5; 95% confidence interval, -2.42 to -1.11; p<0.001) compared with wait-list controls. However, the identified studies had incomplete reporting and uncertain risk of bias, limiting confidence in the estimate.

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
E0746Electromyography (EMG), biofeedback device

References: Andrasik F, Holroyd KA.(1983) Specific and nonspecific effects in the biofeedback treatment of tension headache: 3-year follow-up. J Consult Clin Psychol 1983; 51(4):634-6.

Bussone G, Grazzi L, D'Amico D et al.(1998) Biofeedback-assisted relaxation training for young adolescents with tension-type headache: a controlled study. Cephalalgia 1998; 18(7):463-7.

Campbell JK, Penzien DB, Wall EM.(2000) Evidenced-based guidelines for migraine headache: behavioral and physical treatments. U.S. Headache Consortium 2000. Available at: http://www.aan.com/professionals/practice/pdfs/gl0089.pdf . Last viewed December 2008.

Damen L, Bruijn J, Koes BW et al.(2006) Prophylactic treatment of migraine in children. Part 1. A systematic review of non-pharmacological trials. Cephalalgia 2006; 26(4):373-83.

Eccleston C, Palermo TM, Williams AC et al.(2009) Psychological therapies for the management of chronic and recurrent pain in children and adolescents. Cochrane Database Syst Rev 2009; (2):CD003968.

Gauthier J, Doyon J, Lacroix R et al.(1983) Blood volume pulse biofeedback in the treatment of migraine headache: a controlled evaluation. Biofeedback Self Regul 1983; 8(3):427-42.

Gerber WD, Petermann F, Gerber-von Muller G et al.(2010) MIPAS-Family-evaluation of a new multi-modal behavioral training program for pediatric headaches: clinical effects and the impact on quality of life. J Headache Pain 2010; 11(3):215-25.

Holroyd KA, Andrasik F, Noble J.(1980) A comparison of EMG biofeedback and a credible pseudotherapy in treating tension headache. J Behav Med 1980; 3(1):29-39.

Kroner-Herwig B, Mohn U, Pothmann R .(1998) Comparison of biofeedback and relaxation in the treatment of pediatric headache and the influence of parent involvement on outcome. Appl Psychophysiol Biofeedback 1998; 23(3):143-57.

Martin PR, Forsyth MR, Reece J.(2007) Cognitive-behavioral therapy versus temporal pulse amplitude biofeedback training for recurrent headache. Behav Ther 2007; 38(4):350-63.

Morey SS.(2000) Practice guidelines of the American Academy of Family Physicians. Guidelines on migraine: part 4. General principles of preventive therapy. Am Fam Physician 2000; 62(10):2359-60, 2363. Available at: http://www.aafp.org/afp/20001115/practice.html .

Nestoriuc Y, Martin A.(2007) Efficacy of biofeedback for migraine: a meta-analysis. Pain 2007; 128(1-2):111-27

Nestoriuc Y, Rief W, Martin A.(2008) Meta-analysis of biofeedback for tension-type headache: efficacy, specificity, and treatment moderators. J Consult Clin Psychol 2008; 76(3):379-96.

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.

Sartory G, Muller B, Metsch J et al.(1998) A comparison of psychological and pharmacological treatment of pediatric migraine. Behav Res Ther 1998; 36(12):1155-70.

Scharff L, Marcus DA, Masek BJ.(2002) controlled study of minimal-contact thermal biofeedback treatment in children with migraine. J Pediatr Psychol 2002; 27(2):109-19.

Silberstein SD.(2000) Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2000; 55(6): 754-762. Available at: http://www.neurology.org/cgi/reprint/55/6/754.pdf.

Stubberud A, Varkey E, McCrory DC, et al.(2016) Biofeedback as prophylaxis for pediatric migraine: a meta-analysis. Pediatrics. Aug 2016;138(2). PMID 27462067

Trautmann E, Lackschewitz H, Kroner-Herwig B.(2006) Psychological treatment of recurrent headache in children and adolescents—a meta-analysis. Cephalalgia 2006; 26(12):1411-26.

Verhagen AP, Damen L, Berger MY et al.(2009) Behavioral treatments of chronic tension-type headache in adults: are they beneficial? CNS Neurosci Ther 2009; 15(2):183-205.


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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