An interventional study of Weekly group training in Migraine, Headache Disorders and Pediatric Migraine, sponsored by Medical University Innsbruck. Completed at 1 site in Austria. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Medical University Innsbruck · Not applicable, Interventional, and Prevention
Background: Migraine is a headache disorder highly prevalent in children and adolescents. It significantly affects academic performance and quality of life. A conservative approach to pharmacological prophylaxis for pediatric patients persists in clinical practice, as potential risks must be carefully weighed against the benefits for each individual patient. Non-pharmacological interventions, including physical activity, progressive muscle relaxation (PMR) and psychoeducation have shown promising effects individually but demand a high level of patient motivation. This study protocol creates the foundation to evaluate a novel group therapy program combining high-intensity interval training (HIIT), PMR, and psychoeducation tailored for children and adolescents with migraine.
Methods: This single-centre, open-label, randomized controlled trial will enrol 80 participants aged 13 to 17 years and diagnosed with migraine according to ICHD-3 criteria. Participants are randomized 1:1 into an intervention and control group. The intervention group will receive a 18-week, once-weekly 65-minute group therapy (comprising HIIT and PMR) plus two sessions of psychoeducation. The control group receives no intervention. Primary outcomes are changes in migraine frequency, duration, intensity and acute medication use, assessed through standardized headache diaries before and after the intervention. Secondary outcomes include changes in migraine-related disability (PedMIDAS questionnaire), exploratory analysis of physical activity patterns in a subgroup and a patient-centered evaluation of the intervention's feasibility and perceived effectiveness.
Discussion: This trial will provide evidence on the effectiveness and feasibility of a structured, time-efficient, multimodal group therapy intervention for pediatric migraine. By combining physical and psychological strategies within a supportive group setting, the program aims to overcome key limitations of adherence and offer a non-pharmacological treatment alternative. If successful, the intervention is intended to be incorporated into routine outpatient care for pediatric migraine at the Medical University of Innsbruck.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 6 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Medical University Innsbruck is the lead sponsor of 186 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
Behavioral: Weekly group training
Weekly high-intensity interval training followed by progressive muscle relaxation in a group setting, plus two additional psychoeducation sessions focusing on pain management
Mean change from baseline in migraine headache frequency
Mean change from baseline in the number of monthly headache days, defined as any calendar day with headache.
Time frame: From enrollment to the end of treatment at 4 weeks
Mean change from baseline in migraine intensity
Mean change from baseline in migraine intensity measured using a 0-10 visual analogue scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
Time frame: From enrollment to the end of treatment at 4 weeks
Mean change from baseline in migraine duration
Mean change from baseline in the duration of migraine, expressed as the number of hours of pain per migraine day.
Time frame: From enrollment to the end of treatment at 4 weeks
Degree of migraine-related impairment using the mean change in the PedMIDAS questionnaire´s total score
Migraine-related disability was assessed using the Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire (total score range: 0-276). Higher scores indicate greater migraine-related disability (worse outcome). The outcome parameter was the mean change from baseline in the PedMIDAS total score.
Time frame: From enrollment to the end of treatment at 4 weeks
Plan to share: No — This is a single-center study without the need of sharing IPD with other researchers.
No publications or documents are linked to this record.
Ran from Nov 2025 to primary completion in Jul 2026, 8 months.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 8 months is below that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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