Multimodal Physiotherapy Intervention for People With Migraine

Sponsor
Hochschule Osnabruck
Study ID
NCT07671703
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Multimodal Treatment Program — OTHER
    The intervention is individualized according to each participant's symptoms, functional limitations, and response to treatment progression. Initial sessions focus on detailed physical assessment of headache-related musculoskeletal dysfunctions, including cervical mobility, myofascial trigger points, posture, and vestibular impairments. Intermediate sessions reinforce pain education, home exercise adherence, self-management strategies, and supervised manual and soft tissue techniques. Later sessions emphasize independent exercise progression, activation of deep cervical flexors and extensors, shoulder girdle strengthening, jaw exercises, postural correction, balance training, and supervised ergometer exercise in small groups with heart-rate monitoring. Exercise progression and treatment intensity are adapted according to tolerance and clinical presentation throughout the study period.
  • Usual Care — OTHER
    The comparison group will also receive three prescriptions from the attending physician, but the patients can decide for themselves where they want to undergo physiotherapy. The standard physiotherapy will consist of 18 sessions of 20 minutes each. The attending physiotherapist decides on the entire therapy programme based on their own clinical reasoning. This means that patients are not given any formal educational information as part of the study, nor are they encouraged by their treating physiotherapists to do endurance sports or relaxation therapy on their own.

Study Details

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.

Key Dates

First listed
Jun 26, 2026
Start date
Feb 11, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
195 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Usual Care
    Patients in this group will receive the same number and duration of treatment sessions as the multimodal intervention group. However, they will receive usual physiotherapy care based on the treating physiotherapist's individual clinical reasoning and routine practice. No standardized multimodal protocol will be applied. To minimize contamination between groups and preserve the integrity of the usual care intervention, treatment information and intervention details will not be exchanged between groups or therapists.
  • Experimental: Multimodal Treatment Program
    The multimodal intervention consists of a structured 3-month physiotherapy program delivered by trained physiotherapists following a standardized protocol. The intervention combines migraine education, aerobic exercise, relaxation therapy, manual therapy, neuromuscular exercises, and self-management strategies. Participants receive an educational video about migraine mechanisms, triggers, and treatment approaches. Aerobic exercise includes individually adapted endurance training using heart rate and Borg scale guidance. Daily relaxation exercises using the 4-7-8 breathing technique are recommended. Physiotherapy sessions include manual therapy, cervical and thoracic mobilisation, trigger point treatment, strengthening exercises, balance and vestibular training, stretching, and self-massage techniques. Treatment consists of 12 sessions lasting 40-60 minutes.

Primary Outcome Measure

HIT-6™ [ Time Frame: baseline and through study completion (an average 12 weeks) ]

Central Contacts

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