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FRANK ANDRASIK, PhD Distinguished University Professor, Department of Psychology, Senior Research Scientist, Florida Institute for Human & Machine Cognition, University of West Florida, Pensacola, FL Biofeedback in headache: An overview of approaches and evidence ABSTRACT training, meditation, etc) as well as training in cogni- Biofeedback-related approaches to headache therapy fall tive and behavioral stress coping. The second category into two broad categories: general biofeedback techniques takes a different approach, applying techniques that seek (often augmented by relaxation-based strategies) and more directly to target the aberrant physiology under- methods linked more directly to the pathophysiology under- lying specifi c headache types. This latter category has lying headache. The use of general biofeedback-assisted focused chiefl y on migraine headache and its variants. relaxation techniques for headache has been evaluated This article reviews the supportive evidence for each extensively by expert panels and meta-analyses. Taken category of biofeedback approaches to headache therapy together, these reviews indicate that (1) various forms of and identifi es select areas for future research attention. biofeedback are effective for migraine and tension-type EVIDENCE BASE FOR GENERAL BIOFEEDBACK headache; (2) outcomes with biofeedback rival outcomes TECHNIQUES IN HEADACHE with medication therapy; (3) combining biofeedback Biofeedback-assisted relaxation approaches for headache with medication can enhance outcomes; and (4) despite have been evaluated extensively over the past several effi cacy in many patients, biofeedback fails to bring decades. These evaluations have consisted of two basic signifi cant relief to a sizeable number of headache patients. types—comprehensive reviews by expert panels, and Biofeedback methods that more directly target headache meta-analytic statistical analyses—as detailed below. pathophysiology have focused chiefl y on migraine. These headache-specifi c approaches include blood volume pulse Expert panel reviews biofeedback, which has considerable supportive evidence, A wide variety of groups have assessed biofeedback and and electroencephalographic feedback. related relaxation-based procedures by reviewing all relevant published studies according to rigorous pre- iofeedback has long been employed for helping determined criteria. These groups include the National ameliorate symptoms of recurrent headache; Institutes of Health, the Canadian Headache Society, seminal work was performed in the late 1960s the American Psychological Association, the Society 1,2 Band fi rst reported in the early 1970s. This early of Pediatric Psychology, the Association for Applied work focused mainly on electromyography (EMG) or Psycho physiology and Biofeedback, and the US Head- muscle tension and hand temperature. Today a greater ache Consortium. array of approaches are available, and they fall within The 2000 evidence review by the latter group, the two broad categories: (1) biofeedback-assisted relaxation 4 US Headache Consortium, merits particular mention, and (2) specifi c or more specialized approaches.3 for several reasons. First, their review was sponsored by The fi rst category employs the two types of biofeed- diverse medical societies—namely, the American Acad- back mentioned earlier (EMG and thermal feedback), as emy of Family Physicians, American Academy of Neu- well as feedback on sweat gland activity, to counteract rology, American Headache Society, American College the sympathetic nervous arousal that occurs in response of Emergency Physicians, American College of Physi- to stress for a host of disorders, not just headache. These cians–American Society of Internal Medicine, Ameri- types of biofeedback are commonly augmented with can Osteopathic Association, and National Headache a variety of allied relaxation-based strategies (guided Foundation. Second, this review panel applied objec- imagery, diaphragmatic or paced breathing, autogenic tive criteria, grading the evidence quality as A, B, or C (see Table 1 for details). Third, the panelists examined Dr. Andrasik reported that he has no fi nancial relationships that pose a poten- a diverse array of behavioral and physical treatments tial confl ict of interest with this article. (acupuncture, transcutaneous electrical nerve stimula- doi:10.3949/ccjm.77.s3.13 tion, occlusal adjustment, cervical manipulation, and S72 CLEVELAND CLINIC JOURNAL OF MEDICINE VOLUME 77 • SUPPLEMENT 3 JULY 2010 Downloaded from www.ccjm.org on September 26, 2022. For personal use only. All other uses require permission. ANDRASIK TABLE 1 TABLE 2 Treatment recommendations on behavioral and Patient characteristics for which behavioral treatments physical treatments for migraine from US Headache for migraine may be particularly well suited* 4 Consortium evidence-based guidelines Preference for a nondrug approach Relaxation training, thermal biofeedback combined with Intolerance of, or medical contraindication to, drug treatment relaxation training, electromyographic biofeedback, and cognitive-behavioral therapy may be considered as treatment Absent or minimal response to drug treatment options for prevention of migraine (Grade A evidence*) Pregnancy, plans to become pregnant, or current nursing status Behavioral therapy (ie, biofeedback, relaxation) may be History of long-term, frequent, or excessive use of analgesic or combined with preventive drug therapy to achieve additional other acute medications that aggravate headache symptoms clinical improvement for migraine relief (Grade B evidence*) or are reducing medication effectiveness Evidence-based recommendations are not yet possible on the Presence of signifi cant life stress or lack of adequate stress- use of hypnosis, acupuncture, transcutaneous electrical nerve coping skills stimulation, cervical manipulation, occlusal adjustments, or hyperbaric oxygen as preventive or acute therapy for migraine 4 (Grade C evidence*) *From US Headache Consortium evidence-based guidelines. * Grade A: Multiple well-designed randomized controlled trials (RCTs) revealing a consistent pattern of positive fi ndings. Grade B: Some supportive evidence or with various prophylactic medications for migraine from RCTs, but not optimal support (often because RCTs were few or fi ndings and tension-type headaches in adults and in children were judged to be inconsistent). Grade C: Consensus on the recommendation 7 achieved among consortium members in the absence of acceptable RCTs. and adolescents. The most recent meta-analysis, by 8 Nestoriuc et al, focused extensively on biofeedback and will be discussed in detail here. hyperbaric oxygen) previously identifi ed in a technical Nestoriuc et al identifi ed and screened 150 clinical review prepared for the Agency for Health Care Policy trials, including randomized controlled trials and quasi- 5 8 and Research, a review that included detailed meta- experimental designs. Ninety-four of these trials met analyses as well. Fourth, the panel’s main objective was predefi ned inclusion criteria (headache diagnostic crite- to provide scientifi cally sound and clinically relevant ria specifi ed, biofeedback evaluated as treatment alone practice guidelines for use in primary care settings. or in combination with behavior therapy, outcome Table 1 summarizes the consortium’s resulting treat- assessed using a structured headache diary, 5 or more ment recommendations on behavioral and physical patients per condition, and suffi cient data to permit 4 calculation of effect sizes). It was possible to include a treatments for migraine. The consortium also prepared a suffi cient number of studies to permit comparisons with list of special indicators for behavioral treatment, which 4 two types of control groups: waiting list and placebo. are summarized in Table 2. Thus, strong support was For migraine, biofeedback treatment yielded small to garnered for thermal and EMG biofeedback for migraine, medium effects overall compared with waiting-list con- and this support is consistent with fi ndings from many trol and placebo, although these effects failed to reach meta-analyses addressing not only migraine but also statistical signifi cance. For tension-type headache, tension-type headache (see next section). The panelists biofeedback treatment yielded a medium to large effect noted that there was insuffi cient information for recom- compared with waiting-list control and a medium effect mending which type of treatments to pursue for specifi c compared with placebo, both of which were statistically patients, a conclusion that holds true to the present. 8 signifi cant. Meta-analytic reviews The accompanying fi gures provide a more detailed The other major type of evaluation applied to bio- snapshot of results from the meta-analysis by Nestoriuc feedback for headache is more quantitative in nature, et al. Figure 1 shows effect sizes in terms of headache applying meta-analytical statistical analyses to avail- pain for various biofeedback treatments for migraine. able studies to determine the range and mean level of Figure 2A shows effect sizes for all biofeedback treat- clinical effects across pooled studies. Biofeedback and ments combined for migraine, while Figure 2B shows related approaches to headache have been subject to an effect sizes for EMG biofeedback alone for tension-type extensive number of quantitative reviews, the fi rst being headache (this was the only type of biofeedback with 6 a suffi cient number of studies in tension-type headache published in 1980. Since then, approximately 15 other quantitative reviews have compared behavioral treat- to permit analysis). Both panels of Figure 2 show effect ments with one another, with various placebo conditions, sizes on the four main pain outcome measures used in CLEVELAND CLINIC JOURNAL OF MEDICINE VOLUME 77 • SUPPLEMENT 3 JULY 2010 S73 Downloaded from www.ccjm.org on September 26, 2022. For personal use only. All other uses require permission. BIOFEEDBACK IN HEADACHE Medication index (k = 51) ◆ EEG-FB, skin conductance (k = 7) ◆ Headache index (k = 46) ◆ EMG-FB (k = 7) ◆ Intensity (k = 39) ◆ TEMP-FB (k = 19) ◆ Duration (k = 30) ◆ Frequency (k = 33) ◆ TEMP-FB + RT/EMG-FB (k = 35) ◆ BVP-FB (k = 16) ◆ A 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1.1 1.2 Mean weighted effect sizes (migraine) 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 Mean weighted effect sizes (migraine) Medication index (k = 18) ◆ Headache index (k = 30) ◆ BVP-FB = blood volume pulse feedback; EEG-FB = electroencephalographic feedback; Intensity (k = 27) ◆ EMG-FB = electromyographic feedback; RT = relaxation training; TEMP-FB = peripheral Duration (k = 13) ◆ skin temperature feedback Frequency (k = 28) ◆ 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1.1 1.2 FIGURE 1. Mean weighted effect sizes (and 95% confi dence B Mean weighted effect sizes intervals) for migraine pain for various biofeedback methods from a (tension-type headache) 8 meta-analysis of studies of biofeedback treatment for migraine. FIGURE 2. Mean weighted effect sizes (with 95% confi dence inter- (k = number of independent effect sizes entered into the calculation) With kind permission from Springer Science+Business Media: vals) for various headache outcome measures from a meta-analysis Applied Psychophysiology and Biofeedback, “Biofeedback treatment 8 of studies of biofeedback treatment for headache. Results are for for headache disorders: a comprehensive effi cacy review,” volume 33, all biofeedback procedures combined in the treatment of migraine 2008, p. 131, Nestoriuc Y, Martin A, Rief W, Andrasik F, fi gure 1. (A) and for electromyo graphic biofeedback alone in the treatment of tension-type headache (B). (k = number of independent effect sizes headache research, along with reductions in medica- entered into the calculation) tion (considered a behavior motivated by pain). Figure With kind permission from Springer Science+Business Media: Applied Psychophysiology and Biofeedback, “Biofeedback treatment 3 shows effect sizes from biofeedback on the secondary for headache disorders: a comprehensive effi cacy review,” volume 33, outcome measures of anxiety, depression, and self- 2008, p. 131, Nestoriuc Y, Martin A, Rief W, Andrasik F, fi gure 2. effi cacy, again for all biofeedback procedures for migraine and for EMG biofeedback alone for tension-type head- one investigation suggests that biofeedback may ache. These latter results show that biofeedback has the 14 be of particular value to a subset of patients. added advantage of favorably affecting cognitive and 5) Although not reviewed here, the outcome effects emotional functioning.8 from biofeedback seem to endure for extended Additionally, Holroyd and colleagues have con- 15 periods, whether booster treatments are provided ducted a number of meta-analyses and randomized con- 16 or not. trolled trials that compare behavioral and prophylactic 6) Although biofeedback has been shown to be effec- pharmacologic treatments, as well as their combina- tive for a number of patients, a sizeable number of tion.9–13 These reviews and studies have consistently patients do not achieve signifi cant relief. shown that outcomes for the individual treatments are similar in magnitude and that the combination of both Remaining questions and challenges behavioral and pharmacologic treatment leads to even Unfortunately, little attention has been devoted to iden- greater effects—a conclusion tentatively offered by the tifying variables predictive of outcome. Certain head- 4 US Headache Consortium back in 2000. ache types—chronic forms of headache (presence of pain 15 days per month), headaches associated with the Interim conclusions menstrual cycle, headaches accompanied by medication Consideration of the fi ndings from individual studies overuse (of ergotamine, triptans, analgesics, or opioids), and reviews discussed, plus those not singled out here, posttraumatic headaches, and cluster headaches—have leads to the following conclusions: shown minimal response to biofeedback alone. 1) Various forms of biofeedback are effective for Headaches complicated by medication overuse are migraine and tension-type headache. particularly diffi cult to treat. The fi rst order in treatment 2) Outcomes with these forms of biofeedback rival is to have the patient withdrawn from the offending outcomes with medication alone. agents, which often requires a brief hospitalization, after 3) Combining biofeedback with medication can which a more appropriate course of treatment is begun. enhance outcomes. Unfortunately, relapse is high. Mindful of this, we con- 4) Outcomes from biofeedback are similar to those ducted an investigation that assigned 61 consecutive obtained with other behavioral approaches. patients who had undergone a course of inpatient with- Whether biofeedback has a unique advantage over drawal to either medication alone or medication plus other similar approaches is not known, but at least biofeedback-assisted relaxation training to determine if S74 CLEVELAND CLINIC JOURNAL OF MEDICINE VOLUME 77 • SUPPLEMENT 3 JULY 2010 Downloaded from www.ccjm.org on September 26, 2022. For personal use only. All other uses require permission. ANDRASIK Anxiety (k = 7) ◆ 100 Relapse Depression (k = 6) ◆ 90 Self-efficacy (k = 7) ◆ No relapse 80 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1.1 1.2 70 A Mean weighted effect sizes (migraine) 60 Anxiety (k = 9) 50 ◆ 40 Depression (k = 5) ◆ Self-efficacy (k = 5) ◆ 30 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1.1 1.2 20 Mean weighted effect sizes 10 B (tension-type headache) 0 Medication alone Medication + biofeedback FIGURE 3. Mean weighted effect sizes (with 95% confi dence (n = 38) (n = 16) intervals) for secondary outcome measures related to cognitive and FIGURE 4. Percentage of migraine patients who relapsed to emotional function from a meta-analysis of studies of biofeedback 8 analgesic overuse at 3-year follow-up after being assigned to either treatment for headache. Results are for all biofeedback procedures medication therapy alone or medication therapy combined with combined in the treatment of migraine (A) and for electromyo graphic biofeedback-assisted relaxation to combat initial analgesic overuse. biofeedback alone in the treatment of tension-type headache (B). 17 (k = number of independent effect sizes entered into the calculation) Data are from a study by Grazzi et al. With kind permission from Springer Science+Business Media: Applied Psychophysiology and Biofeedback, “Biofeedback treatment EEG-based methods for headache disorders: a comprehensive effi cacy review,” volume 33, The next most investigated approach involves electro- 2008, p. 131, Nestoriuc Y, Martin A, Rief W, Andrasik F, fi gure 2. encephalographic (EEG) biofeedback, of which there 17 are two types. The fi rst derives from research investi- such training could enhance outcome. At 1-year fol- gating links between certain EEG frequency bands and low-up evaluation, the two patient groups showed simi- 19 lar levels of improvement. However, at 3-year follow-up, the experience of pain. This research suggests that the patients receiving biofeedback showed more sustained experience of pain is associated with lower amplitudes improvements and, most importantly, had lower rates of slow brain wave activity (delta, theta, and alpha) and of relapse back to analgesic overuse (Figure 4). Thus, higher amplitudes of faster brain wave activity (beta). biofeedback seemed to help these patients cope more Several uncontrolled series suggest that EEG biofeedback effectively over the long term. Unfortunately, we did may be of value, but more well-controlled investigations not collect suffi cient data over the intervening 2 years, are needed before further statements can be made. so we could not determine with precision what medi- The second line of EEG research takes a differ- ated this differential outcome. ent approach, focusing on the contingent negative variation response (CNV). The CNV is a slow corti- EVIDENCE BASE FOR HEADACHE-SPECIFIC cal event-related potential that examines EEG activity BIOFEEDBACK APPROACHES occurring between presentation of a warning stimulus and an imperative stimulus (in this case 3 seconds As noted above, a number of biofeedback approaches later), a stimulus requiring a response by the individual. have been suggested that are tied more directly to the This potential is related to the level of excitability upon underlying physiology of headache. activation in the striato thalamocortical loop, refl ecting different stages of information processing.20 Studies in Blood volume pulse biofeedback child and adult migraineurs reveal that these patients One of these approaches, blood volume pulse (BVP) bio- have a heightened response to novel stimuli and do feedback, has undergone a suffi cient number of trials to not habituate as readily over repeated trials as do non- 21 be included in the recent meta-analysis by Nestoriuc et migraineur controls. The CNV is believed to refl ect 8 anticipation of a migraine attack because its amplitude al mentioned earlier. This approach involves monitoring blood fl ow in the temporal artery and providing feedback and habituation patterns change during the headache- to patients to enable them to decrease or constrict blood free interval. Abnormalities gradually increase in the 18 days before a migraine attack, with the most pronounced fl ow. This approach, when fi rst envisioned, was viewed 22 as the nondrug counterpart to the abortive agent ergota- changes occurring just prior to the attack. mine. Although BVP biofeedback is not very common On the basis of these etiopathologic fi ndings, Sini- 8 atchkin et al conducted an initial test to determine in clinical practice, the meta-analysis by Nestoriuc et al found it to produce the greatest effect size of the biofeed- whether child migraineurs could learn, via biofeedback, back methods assessed for migraine relief (Figure 1). to change their CNV activity and whether such learning CLEVELAND CLINIC JOURNAL OF MEDICINE VOLUME 77 • SUPPLEMENT 3 JULY 2010 S75 Downloaded from www.ccjm.org on September 26, 2022. For personal use only. All other uses require permission.
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