App-based self-administered biofeedback for the prevention of episodic migraine: A randomized controlled trial
Abstract
Aim To evaluate the efficacy and safety of a fully self-administered, app-based biofeedback intervention for the prevention of episodic migraine Methods This open-label, randomized, waitlist-controlled multicenter trial included adults with episodic migraine assigned to 12 weeks of daily biofeedback or a waitlist control. The primary outcome was change in monthly migraine days (MMDs) from baseline to weeks 9–12. Secondary outcomes included migraine intensity, acute medication use, and migraine-specific quality of life (MSQ v2.1). Statistical analyses were performed according to the intention-to-treat principle by a statistician masked to treatment assignment. Results Of 1113 individuals screened, 279 participants (mean [SD] age, 41 [10] years; 92% women) were randomized to the intervention (n = 140) or waitlist control (n = 139). Baseline MMDs were 4.8 (2.4) and 4.6 (2.3) in the intervention and control groups, respectively. During weeks 9–12, the estimated reduction in MMDs was 0.9 days (95% CI, −1.4 to −0.5) in the intervention group and 0.0 days (95% CI, −0.5 to 0.4) in the control group (between-group difference, 0.9 days; 95% CI, 0.3 to 1.5; P = 0.002). Participants receiving biofeedback also showed greater improvements in MSQ v2.1 total scores (mean difference, 5.3 points; 95% CI, 2.1 to 8.6; P = 0.001). Nine device-related adverse events occurred, all with mild severity. Conclusion App-based self-administered biofeedback was associated with a statistically significant…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,113 participants or records.
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