Effectiveness of Multimodal Physical Therapy for Episodic and Chronic Migraine With Concomitant Cervical Musculoskeletal Dysfuntions: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in screening period monthly migraine days at the end of the intervention period (week 20) and at the end of the study (week 28) (daily migraine report)
研究概览
简要总结
INTRODUCTION: It is very common that migraine patients could refer neck pain during or after the pain phase of migraine, suggesting that migraine pathophysiological mechanisms could be effective in activating neck pain pathways and be part of the migraine attack. Due to the therapeutic effect of multimodal physical therapy (mobilization and/or manipulation plus exercises) on several pain conditions arising from articular and/or muscular structures such as neck pain, and given the close clinical, anatomical and pathogenetic bi-directional relationship between neck pain and migraine, it would be of interest to evaluate the effectiveness of the physical treatment of the neck region in migraine pain.
PURPOSE: to evaluate the efficacy of a combined multimodal physical therapy approach plus usual care vs. usual care alone in subjects with episodic and chronic migraine with concomitant cervical musculoskeletal dysfunctions.
STUDY DESIGN: this is a prospective, parallel group, randomized clinical trial. METHODS: A total of 56 subjects aged 18-65 who meet criteria for episodic or chronic migraine with concomitant cervical musculoskeletal dysfunctions will be randomly assigned to receive, musculoskeletal focused multimodal physical therapy (16 sessions over 8 weeks) plus usual care treatment vs. usual care alone.
CONFLICT OF INTEREST: not declared.
详细描述
Study design This is a prospective, parallel group, randomized clinical trial evaluating multimodal care plus usual care vs. usual care alone in episodic and chronic migraine with concomitant muscoloskeletal dysfunctions.
The total study duration from the Screening Visit to the Completion Visit is approximately 28 weeks and includes a Screening Period (12 weeks) and an intervention period (8 weeks) followed by an observational period post treatment (8 weeks) for each participant.
Procedures Eligible patients who provided informed consent started the screening period of 12 weeks to confirm migraine frequency, stable prophylactic migraine treatment, including and inclusion/exclusion criteria. During the screening period patients collected informations including number of monthly migraine days, use of acute medication, migraine days with use of acute medication, headache severity (graded as mild, moderate or severe) and duration by using daily migraine report. Migraine associate disability (MIDAS), neck associated disability (NDI) and level of depression (PHQ-9) were detected by using appropriate tests at the end of the 12-week screening period (week 12), at the end of the 8-week intervention period (week 20), and at the end of the study 8 weeks after the last treatment (week 28). During the screening period each participant underwent a physical examination test by physical therapists (LDA, FL, MS) specialized in manual therapy to detect cervical musculoskeletal dysfunctions, including temporomandibular disorders, which are potentially tractable with physical therapy. Physical examination assessed cervicothoracic spine posture, ranges of motion, presence of myofascial trigger points, cervical and temporo-mandibular joint movement restriction.
Procedures Participants who have completed the screening period will be randomized 1:1, using an automatic allocation system, to receive multimodal physical therapy treatment in addition to standard pharmacological treatment or standard pharmacological treatment alone (usual care). The sample will be stratified according to the diagnosis of headache (episodic migraine or chronic migraine), cervical and / or temporomandibular musculoskeletal dysfunction and concomitant myofascial disorder. After 8 weeks of treatment, participants will be monitored for a follow-up phase free of physical treatment lasting an additional 8 weeks.
A research assistant in the study (NM) will monitor the blinding of the study and assign the participants to the intervention.
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 (Care Provider, Investigator)
盲法说明
Physiotherapists are blinded toward the diagnosis and outcome measures.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Multimodal Physical therapy approach plus usual care
HVLA spinal manipulation, mobilization, soft tissue treatment, therapeutic exercise, education, plus standard pharmacological treatment.
干预措施: Multimodal Physical therapy approach plus usual care (Procedure)
Multimodal Physical therapy approach plus usual care
HVLA spinal manipulation, mobilization, soft tissue treatment, therapeutic exercise, education, plus standard pharmacological treatment.
干预措施: Usual care (Drug)
结局指标
主要结局
Change in screening period monthly migraine days at the end of the intervention period (week 20) and at the end of the study (week 28) (daily migraine report)
时间窗: At the end of the 12-week screening period (week 12), at the end of the 8-week intervention period (week 20), and at the end of the study 8 weeks after the last treatment (week 28)
Number of monthly migraine days
Change in screening period monthly migraine days with use of acute medication at the end of the intervention period (week 20) and at the end of the study (week 28) (daily migraine report)
时间窗: At the end of the 12-week screening period (week 12), at the end of the 8-week intervention period (week 20), and at the end of the study 8 weeks after the last treatment (week 28)
Monthly migraine days with use of acute medication
次要结局
- Change in screening period Migraine Disability Assessment Score (MIDAS) at the end of the intervention period (week 20) and at the end of the study (week 28)(At the end of the 12-week screening period (week 12), at the end of the 8-week intervention period (week 20), and at the end of the study 8 weeks after the last treatment (week 28))
- Change in screening period Neck disability index (NDI) at the end of the intervention period (week 20) and at the end of the study (week 28)(At the end of the 12-week screening period (week 12), at the end of the 8-week intervention period (week 20), and at the end of the study 8 weeks after the last treatment (week 28))
- Change in screening period Patient Health Questionnaire-9 (PHQ-9) at the end of the intervention period (week 20) and at the end of the study (week 28)(At the end of the 12-week screening period (week 12), at the end of the 8-week intervention period (week 20), and at the end of the study 8 weeks after the last treatment (week 28))
研究者
Armando Perrotta
Principal Investigator
Neuromed IRCCS