Clinical trial
Effectiveness of Multimodal Physical Therapy for Episodic and Chronic Migraine With Concomitant Cervical Musculoskeletal Dysfuntions: Randomized Clinical Trial
Name
MIGRA012021
Description
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.
Trial arms
Trial start
2022-02-24
Estimated PCD
2024-12-01
Trial end
2025-05-01
Status
Recruiting
Treatment
Multimodal Physical therapy approach plus usual care
HVLA spinal manipulation, mobilization, soft tissue treatment, therapeutic exercise, education, plus standard pharmacological treatment.
Arms:
Multimodal Physical therapy approach plus usual care
Other names:
Intervention group
Usual care
Standard pharmacological treatment alone.
Arms:
Multimodal Physical therapy approach plus usual care
Other names:
Usual care group
Size
36
Primary endpoint
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)
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 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)
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)
Eligibility criteria
Inclusion criteria
* patients aged 18-65 years;
* patients with episodic migraine with and without aura (experiencing 6-14 days/month with migraine);
* patients with chronic migraine;
* patients who achieved \>30% \<50% reduction from their individual baseline in the number of monthly migraine days on therapy with standard stable pharmacological treatments during the past 3 months;
* concomitant cervical dysfunctions.
Exclusion criteria
* self-report of neck injury/trauma;
* acute radiculopathy;
* history of carotid or vertebral artery dissection;
* stroke;
* cervical/cranial nerve block in the past three months;
* pregnancy;
* history of infection;
* migraine attack during the assessment;
* diagnosis of other concomitant headaches (such as cervicogenic headache, tension-type headache, cluster headache, medication overuse headache);
* having received physical treatment in the past three months or botulinum toxin in the past six months;
* any unstable medical o psychiatric condition.
* history of any other rheumatic or chronic diseases such as fibromyalgia;
* neuralgias, or self-report of vestibular disease.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, parallel group, randomized clinical trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Physiotherapists are blinded toward the diagnosis and outcome measures.', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}
Updated at
2024-02-28
1 organization
1 product
3 indications
Organization
Neuromed IRCCSProduct
Usual careIndication
MigraineIndication
Musculoskeletal Neck PainIndication
Neck Musculoskeletal Disorder