Multimodal Physiotherapy Intervention for People With Migraine

NCT07671703 | Recruiting

• 1 other identifier: 1296/2026
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine; Pain education; Aerobic exercises; Relaxation training; Manual therapy; Localized exercises; Prediction of success

Outcome Measures

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).

  baseline and through study completion (an average 12 weeks)

Secondary Outcomes (17)

• Headache related signs and symptoms

  baseline and through study completion (an average 12 weeks)

• Pain intensity

  baseline and through study completion (an average 12 weeks)

• Graded chronic pain scale

  baseline and through study completion (an average 12 weeks)

• Pain severity and pain interference

  baseline and through study completion (an average 12 weeks)

• Neck-related disability

  baseline and through study completion (an average 12 weeks)

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Multimodal Treatment Program

EXPERIMENTAL

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.

Other: Multimodal Treatment Program

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.

Multimodal Treatment Program

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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hochschule Osnabruck: lead

Study Sites (1)

Capu Motion: Die Physio- und Ergotherapeuten GbR

Osnabrück, Low Saxony, 49076, Germany

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Marie Marks MM Marks, Bachelor in Physiotherapy

CONTACT

+49 170 3079512; marieKempe@web.de

Susan Armijo-Olivo L Armijo-Olivo, PhD

CONTACT

+49 1522 3170807; susanarmijo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed of the study's specific hypotheses, and intervention descriptions will be kept neutral to avoid performance bias. Subjects will be told that both interventions are effective for managing migraine. Outcome assessors (measuring clinician-assessed outcomes) will be blinded to group assignments (to avoid detection bias), and the statistician will be blinded throughout the analysis, in accordance with established guidelines. Furthermore, therapists are assigned exclusively to a single study arm; those delivering the multimodal intervention will not provide standard care, and vice versa (to decrease performance/contamination bias). The allocation sequence will be uploaded to a secure online system, and access will be restricted to the study coordinator responsible for assigning participants to therapists. This procedure ensured allocation concealment, as all other study personnel remained unaware of the randomization sequence and upcoming group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 26, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

DE (1)