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Real-Time Assessment of the Effect of Biofeedback Therapy with Migraine: A Pilot Study
Miyuki Odawara1, Masahiro Hashizume2, Kazuhiro Yoshiuchi3
1Department of Psychosomatic Medicine, Faculty of Medicine, Toho University, 6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan. mykodawara@med.toho-u.ac.jp.
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.
