NCT07671703 Multimodal Physiotherapy Intervention for People With Migraine
| NCT ID | NCT07671703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hochschule Osnabruck |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 195 participants |
| Start Date | 2026-02-11 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 195 participants in total. It began in 2026-02-11 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Migraine is one of the most prevalent primary headache disorders worldwide and is associated with substantial impairments in quality of life, work productivity, and psychosocial functioning. In Germany alone, nearly 18 million people are affected. Although pharmacological therapy remains a cornerstone of migraine management, non-pharmacological interventions-particularly physiotherapy-play an important role in multimodal treatment concepts and are generally well tolerated. Recent evidence suggests that physiotherapy for migraine should extend beyond conventional manual techniques and include patient education, aerobic endurance training, and self-management strategies. However, in routine clinical practice, physiotherapeutic approaches vary widely and are often not fully aligned with current evidence-based recommendations. Moreover, there is a lack of pragmatic randomized controlled studies evaluating the effectiveness of structured, evidence-based multimodal physiotherapy compared with conventional physiotherapy under real-world clinical conditions. This study is a randomized controlled pilot trial designed to compare an evidence-based multimodal physiotherapeutic intervention with conventional physiotherapy in adult patients with migraine. The multimodal intervention consists of evidence-based physiotherapy, structured patient education on migraine and pain mechanisms, guided moderate aerobic endurance training, and relaxation techniques. The control group receives conventional physiotherapy according to German standard clinical practice. The study is designed as a randomized controlled trial with a pre-post design. Adult patients aged 18 to 60 years with a specialist-confirmed diagnosis of migraine will be recruited from a specialized pain therapy center in Osnabrück, Germany. Participants will be randomly allocated to either the multimodal treatment group or the usual care physiotherapy group. The intervention period lasts three months. The primary outcome is migraine-related quality of life measured using the Headache Impact Test (HIT-6™). Secondary outcomes include headache frequency and intensity assessed via headache diaries, migraine-related work absenteeism, and functional impairment. Feasibility outcomes will be evaluated through the feasibility and acceptance of the multimodal treatment program from the perspective of the treating physiotherapists. The results are expected to provide robust evidence on the effectiveness and real-world applicability of multimodal treatment programs compared with usual care for migraine management in Germany. Embedded to this project there is also the prediction analysis. For that patients will be divided into those who responded to the treatment and those who stay stable or get worse after treatment. Based on that a statistical analysis will be used to assess which factors influenced the improvement of those patients after physical therapy treatment.
Eligibility Criteria
Inclusion Criteria * Aged 18-70 years. * Have a diagnosis of migraine established by a headache specialist according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). * Have experienced migraine symptoms for more than 3 months, with headaches occurring on at least 2 days per month. * Provide written informed consent before participation. * Complete a study-specific self-assessment questionnaire based on the ICHD-3 criteria to confirm the migraine diagnosis and classify participants as having episodic or chronic migraine. Exclusion Criteria * Other primary or secondary headache disorders. * Acute neurological diseases or abnormal neurological examination findings. * Rheumatic diseases, vascular diseases, cancer, or other serious medical conditions. * Comorbid chronic pain disorders (e.g., fibromyalgia). * Diagnosed psychiatric disorders (e.g., major depression or schizophrenia). * Substance abuse. * Physiotherapy for headache or neck pain within 3 months before study enrolment. * Previous surgery involving the jaw, cervical spine, or head. * Pregnancy. * Pain not clearly attributable to migraine. * Inability or unwillingness to provide informed consent. * There are no restrictions regarding sex, ethnicity, or country of residence.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07671703 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07671703 currently recruiting?
Yes, NCT07671703 is actively recruiting participants. Contact the research team at marieKempe@web.de for enrollment information.
Where is the NCT07671703 trial being conducted?
This trial is being conducted at Osnabrück, Germany.
Who is sponsoring the NCT07671703 clinical trial?
NCT07671703 is sponsored by Hochschule Osnabruck. The trial plans to enroll 195 participants.
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