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



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.


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.


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).


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.


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

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Ethical Standards

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. Informed consent was obtained from all patients for being included in the study

Conflict of Interest

Miyuki Odawara, Masahiro Hashizume, Kazuhiro Yoshiuchi, and Koji Tsuboi declare that they have no conflict of interest.

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Correspondence to Miyuki Odawara.

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Odawara, M., Hashizume, M., Yoshiuchi, K. et al. Real-Time Assessment of the Effect of Biofeedback Therapy with Migraine: A Pilot Study. Int.J. Behav. Med. 22, 748–754 (2015).

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  • Migraine
  • Ecological momentary assessment
  • Biofeedback
  • Psychological stress
  • Headache-related disability
  • Multilevel model