Real-Time Assessment of the Effect of Biofeedback Therapy with Migraine: A Pilot Study

Int J Behav Med. 2015 Dec;22(6):748-54. doi: 10.1007/s12529-015-9469-z.


Background: Biofeedback therapy has been reported to be effective in the treatment of migraine. However, previous studies have assessed its effectiveness using paper-and-pencil diaries, which are not very reliable.

Purpose: The objective of the present pilot study was to investigate the feasibility of using computerized ecological momentary assessment (EMA) for evaluating the efficacy of BF treatment for migraine in a randomized controlled trial.

Method: The subjects comprised one male and 26 female patients with migraine. They were randomly assigned to either biofeedback or wait-list control groups. Patients were asked to carry a palmtop-type computer to record momentary symptoms for 4 weeks before and after biofeedback treatment. The primary outcome measure was headache intensity. The secondary outcome measures included psychological stress, anxiety, irritation, headache-related disability and the frequency (number of days per month) of migraine attack and of headache of at least moderate intensity (pain rating ≥50).

Results: Headache intensity showed significant main effects of period (before vs. after therapy, p = 0.02) and group (biofeedback vs. control groups, p = 0.42) and a significant period × group interaction (p < 0.001). Biofeedback reduced the duration of headaches by 1.9 days, and the frequency of days when headache intensity was ≥50 by 2.4 times. In addition, headache-related disability, psychological stress, depression, anxiety, and irritation were significantly improved.

Conclusion: The present study used computerized EMA to show that biofeedback could improve the symptoms of migraine, including psychological stress and headache-related disability.

Keywords: Biofeedback; Ecological momentary assessment; Headache-related disability; Migraine; Multilevel model; Psychological stress.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Biofeedback, Psychology / methods*
  • Disability Evaluation
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Migraine Disorders* / psychology
  • Migraine Disorders* / therapy
  • Pain Measurement / methods
  • Pilot Projects
  • Stress, Psychological* / diagnosis
  • Stress, Psychological* / physiopathology
  • Symptom Assessment / methods