Description:
Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. Biofeedback is frequently used in conjunction with other therapies (e.g., relaxation, behavioral management, medication) to reduce the severity and/or frequency of headaches.

For individuals who have migraine or tension-type headache who receive biofeedback, the evidence includes randomized controlled trials and systematic reviews of these trials. Relevant outcomes are symptoms, functional outcomes, and quality of life. The literature, which includes meta-analyses of a large number of controlled and uncontrolled studies, has suggested that this treatment can reduce the frequency and/or severity of migraine and tension-type headaches. Biofeedback, along with other psychologic and behavioral techniques (e.g., relaxation training) may be particularly useful for children, pregnant women, and other adults who are not able to take medications. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. 

For individuals who have cluster headache who receive biofeedback, the evidence includes case reports and small case series. Relevant outcomes are symptoms, functional outcomes, and quality of life. No controlled trials were identified on biofeedback for cluster headache. The evidence is insufficient to determine the effects of the technology on health outcomes. 

Clinical input and physician specialty society recommendations have strongly supported the use of biofeedback to treat migraine and tension-type headaches when included in a comprehensive treatment program.

Background
Migraine, tension-type, and cluster headache are all primary headaches with distinct presentations.¹ Migraine is characterized by intense, often localized, pain or throbbing usually accompanied by nausea, vomiting, light and/or sound sensitivity. Tension headache pain tends to be less intense and may be bilateral or encircle the head. Both migraine and tension-type headache are relatively common conditions. Cluster headache occurs less frequently. Subjects with cluster headache have brief but intensely painful attacks that occur multiple times per day. Cluster attacks may last days, weeks or months.

Biofeedback involves the feedback of a variety of types of physiologic 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 physiologic 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 to 60 minutes each. Training sessions are performed in a quiet, nonarousing environment. Subjects are instructed to use mental techniques to affect the physiologic variable monitored, and feedback is provided for the 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 subject attempts to control, and the information that is fed back to the subject. Biofeedback techniques include peripheral skin temperature feedback, blood-volume-pulse feedback (vasoconstriction and dilation), vasoconstriction training (temporalis artery), and electromyographic biofeedback; these may be used alone or in conjunction with other therapies (e.g., relaxation, behavioral management, medication). In general, electromyographic 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 the achievement of a decrease in muscle tension is provided to the subject, reinforcing those activities (behaviors or thoughts) that are effective. Thermal biofeedback is a commonly employed technique for migraine headache, in which patients learn to increase the temperature of their fingertips through the use of imagery and relaxation. 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 combination of thermal biofeedback and relaxation training has also been used to improve migraine symptoms. 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.

Regulatory Status
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 FDA as class II with special controls and are exempt from the premarket notification requirements. 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.”

Related Policies
20127 Biofeedback as a Treatment of Urinary Incontinence in Adults
20130 Biofeedback as a Treatment of Chronic Pain
20153 Biofeedback for Miscellaneous Indications
20164 Biofeedback as a Treatment of Fecal Incontinence or Constipation

Policy:
Biofeedback may be considered MEDICALLY NECESSARY as part of the overall treatment plan for migraine and tension-type headache.

Biofeedback for the treatment of cluster headache is investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY.

Unsupervised home use of biofeedback for treatment of headache is NOT MEDICALLY NECESSARY.
This policy only considers biofeedback as a treatment of headache.

Policy Guidelines
Biofeedback may require 10 to 20 office-based sessions of 30 to 60 minutes each.

Coding
Please see the Codes table for details.

Rationale
This evidence review was created in April 1998 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through September 12, 2023.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Migraine and Tension-Type Headache
Clinical Context and Therapy Purpose
The purpose of biofeedback for individuals who have migraines or tension-type headaches is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with migraines or tension-type headaches.

Interventions
The therapy being considered is biofeedback.

Comparators
The following therapy is currently being used to treat migraines or tension-type headaches: standard therapy without biofeedback.

Outcomes
The general outcomes of interest are reductions on instances and intensity of migraines or tension-type headaches and reductions in medication usage. The intent of biofeedback use is for the prevention of migraine or tension-type headache. The American Headache Society² identified the following treatment goals of preventive biobehavioral therapy (including biofeedback):

• Reduced frequency and severity of headache
• Reduced headache-related disability
• Reduced reliance on poorly tolerated or unwanted pharmacotherapies
• Enhanced personal control of migraine
• Reduced headache-related distress and psychological symptoms

Follow-up over the course of 10 to 20 sessions would be of interest to monitor for outcomes.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Adults
Systematic Reviews
Nestoriuc et al. (2007, 2008) published systematic reviews on biofeedback for migraines and tension-type headaches.^3,4 Meta-analysis for the treatment of migraine included 55 studies (randomized, pre-post, uncontrolled) with 39 controlled trials, reporting a pooled medium effect size of 0.58 (95% confidence interval [CI], 0.52 to 0.65) for treatment of migraine.³ Effect sizes were computed using Hedges’ g, which quantifies between-group treatment outcome differences (mean difference [MD] between groups divided by the pooled standard deviation). For the treatment of tension-type headaches, 53 studies met criteria for analysis; they included controlled studies with standardized treatment outcomes, follow-up of at least 3 months, and at least 4 patients per treatment group.⁴ Meta-analysis showed a medium-to-large effect size of 0.73 (95% CI , 0.61 to 0.84) 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 2 therapies. Although these meta-analyses were limited by the inclusion of studies of poor methodologic quality, reviewers did not find evidence of an influence of study quality or publication bias in their findings.

Verhagen et al. (2009) conducted a systematic review of behavioral treatments for chronic tension-type headaches in adults.⁵ 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 reviewers to conclude that larger and more methodologically robust studies should be performed.

Children and Adolescents
Systematic Reviews
Stubberud et al. (2016) reported on a meta-analysis of biofeedback as prophylaxis for pediatric migraines.⁶ They identified 5 RCTs (total n = 137 children and adolescents) that met inclusion criteria. Mean age among the 5 included RCTs ranged from 10 to 13 years. Meta-analysis found that biofeedback reduced migraine frequency (MD in attacks per week, -1.97 ;95% CI , -2.72 to -1.21; p < .001), attack duration (MD , -3.94; 95% CI , -5.57 to -2.31; p < .001), and headache intensity (MD , -1.77 out of 5; 95% CI , -2.42 to -1.11; p < .001) compared with wait-list controls. However, the identified studies had incomplete reporting and uncertain risk of bias, limiting confidence in the estimates.

Section Summary: Migraine and Tension-Type Headache
The evidence on biofeedback for the treatment of migraines and tension-type headaches includes meta-analyses of numerous RCTs. Systematic reviews have found significant effects of biofeedback on headache frequency and intensity in both children and adults. Biofeedback in combination with relaxation is more effective than relaxation alone, suggesting that these act independently.

Cluster Headache
Clinical Context and Therapy Purpose
The purpose of biofeedback for individuals who have cluster headache is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with cluster headache.

Interventions
The therapy being considered is biofeedback.

Comparators
The following therapy is currently being used to treat cluster headache: standard therapy without biofeedback.

Outcomes
The general outcomes of interest are reductions on instances and intensity of cluster headache and reduction in medication usage. The intent of biofeedback use is for the prevention of cluster headache. The American Headache Society² identified the following treatment goals of preventive biobehavioral therapy (including biofeedback):

• Reduced frequency and severity of headache
• Reduced headache-related disability
• Reduced reliance on poorly tolerated or unwanted pharmacotherapies
• Enhanced personal control of migraine
• Reduced headache-related distress and psychological symptoms
• Follow-up over the course of 10 to 20 sessions would be of interest to monitor for outcomes

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Only small case series and case reports were identified in the treatment of cluster headache with biofeedback. No controlled trials were found.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers
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.

2009 Input
In response to requests, input was received from 3 physician specialty societies and 3 academic medical centers (4 inputs) while this policy was under review in 2009. Input considered biofeedback to be a reliable and appropriate nonpharmacologic option for the treatment of headaches.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in "Supplemental Information" if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Headache Society
In 2021, the American Headache Society released a consensus statement on integration of new migraine treatments into clinical practice, including biobehavioral therapies (cognitive behavioral therapy, biofeedback, and relaxation).² According to the consensus statement, "Biobehavioral therapies have Grade A evidence supporting their use as preventive treatments in patients with migraine." The statement notes that biobehavioral therapies are particularly suited for the following individuals:

• Prefer nonpharmacologic interventions
• Have inadequate response, poor tolerance, or medical contraindications to specific pharmacologic treatments
• Are pregnant, lactating, or planning to become pregnant
• Have a history of acute medication overuse or medication-overuse headache
• Exhibit significant stress or deficient stress-coping skills
• Have high migraine-related disability, and/or low health-related quality of life, and/or comorbidities

Association for Applied Psychophysiology and Biofeedback
In 2013, the Association for Applied Psychophysiology and Biofeedback issued standards for performing biofeedback.⁷ The standards stated that biofeedback for the treatment of migraine and tension headache has been validated as being safe and effective for these conditions and that biofeedback is not used alone as a diagnostic tool or treatment; rather, it is an adjunctive tool used in combination with other standard interventions.

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

References  

1. Baraness L, Baker AM. Acute Headache. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; Updated July 26, 2023. Accessed September 12, 2023.
2. Ailani J, Burch RC, Robbins MS. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. Jul 2021; 61(7): 1021-1039. PMID 34160823
3. Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain. Mar 2007; 128(1-2): 111-27. PMID 17084028
4. Nestoriuc Y, Rief W, Martin A. Meta-analysis of biofeedback for tension-type headache: efficacy, specificity, and treatment moderators. J Consult Clin Psychol. Jun 2008; 76(3): 379-96. PMID 18540732
5. Verhagen AP, Damen L, Berger MY, et al. Behavioral treatments of chronic tension-type headache in adults: are they beneficial?. CNS Neurosci Ther. 2009; 15(2): 183-205. PMID 19499626
6. Stubberud A, Varkey E, McCrory DC, et al. Biofeedback as Prophylaxis for Pediatric Migraine: A Meta-analysis. Pediatrics. Aug 2016; 138(2). PMID 27462067
7. Association for Applied Psychphysiology and Biofeedback. Standards for Performing Biofeedback. 2013; https://aapb.org/Standards_for_Performing_Biofeedback. Accessed September 12, 2023.
8. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Biofeedback Therapy (30.1). n.d.; https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=41&ncdver=1. Accessed September 12, 2023.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.  

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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