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

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.