Miyuki Odawara1, Masahiro Hashizume2, Kazuhiro Yoshiuchi3, Koji Tsuboi2. 1. Department of Psychosomatic Medicine, Faculty of Medicine, Toho University, 6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan. mykodawara@med.toho-u.ac.jp. 2. Department of Psychosomatic Medicine, Faculty of Medicine, Toho University, 6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan. 3. Department of Psychosomatic Medicine, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Abstract
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.
RCT Entities:
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.
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