About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Multimodal Treatment Program
Other intervention
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 intervention
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.

Treatment groups

195 Participants

are divided into 2 treatment groups

Group A: Usual CareActive comparator 1 intervention

Group B: Multimodal Treatment ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

HIT-6™

To determine the effectiveness of the multimodal treatment for patients with migraine, the primary outcome measure will be the Headache Impact Test Short Form (HIT-6TM), a questionnaire on headache-related limitations in functioning and well-being (16). It is headache-specific and asks about the frequency of certain impairments. It is a reliable and valid questionnaire for people with episodic and chronic migraine (17). The intraclass correlation (test-retest reliability) is 0.77. The psychometric properties of the German translation are equivalent to those of the English version. The clinically relevant change is 2.5-6 points for migraine and 8 points for chronic tension-type headaches. (14).

Time frame