What is the Effectiveness of an Evidence-based Multimodal Intervention When Compared With Conventional Physiotherapy, and Which Factors Determine Treatment Success in Patients With Migraine- a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- HIT-6™
研究概览
简要总结
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.
详细描述
2. Scope: Migraine can significantly impair quality of life and pose substantial economic burdens to those affected and society. Migraine, a common neurological disorder that often begins in early life, can lead to developmental limitations, high rates of suicide, and reduced work productivity.
Migraine could be treated with various physiotherapeutic modalities, especially exercises. However, selecting the appropriate treatment approach can be challenging due to the need for personalized, evidence-based interventions.
At centers like Schmerztherapiezentrum Dr. Brau und Dr. Michel and Capu Motion in Osnabrück, interdisciplinary treatments for migraine are being explored, with a strong emphasis on physiotherapy, which offers a non-invasive alternative without the side effects associated with drugs. While recent advancements in evidence-based practices have been made, their implementation in clinical settings remains scarce.
This project aims to optimize physiotherapy interventions by integrating recent evidence, emphasizing a combination of patient education, endurance training, specific exercises and techniques, and self-management. By advancing research and applying new evidence in practice, the project seeks to improve patient outcomes, enhance treatment effectiveness, and reduce healthcare costs, ultimately improving quality of life for individuals affected by migraine. In addition, this project seeks to understand the interactions among biopsychosocial factors, including demographic diversity, physical assessment, and psychological variables, which are crucial for tailoring interventions. Additionally, considering variations in health systems, treatments, infrastructure, and clinical practices, especially within Germany, is essential for developing comprehensive treatment strategies for patients suffering from these complex conditions. This research aims to identify the most effective treatment methods within the German clinical context, potentially serving as a model for other countries and improving global treatment approaches for patients with migraine.
This pilot trial has several objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
HIT-6™
时间窗: baseline and through study completion (an average 12 weeks)
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).
次要结局
- 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))
- Physical assessment - Upper cervical mobility(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))
- Change in quality of life(baseline and through study completion (an average 12 weeks))
- Psycho-social factors(baseline and through study completion (an average 12 weeks))
- Expectancy and Alliance(baseline and through study completion (an average 12 weeks))
- Perception of improvement(through study completion (an average 12 weeks))
- Adverse events(on every treatment session (from Day 1 to Day 18))
- Physical assessment - Neck performance(baseline and through study completion (an average 12 weeks))
- Physical assessment - Neck mobility(baseline and through study completion (an average 12 weeks))
- Physical assessment - Neck coordination and control(baseline and through study completion (an average 12 weeks))
- Physical assessment - Neck proprioception(baseline and through study completion (an average 12 weeks))
- Physical assessment - Overall pain sensitivity(baseline and through study completion (an average 12 weeks))
- Physical assessment - Pericranial tenderness(baseline and through study completion (an average 12 weeks))