Effectiveness of Multimodal Physical Therapy in Migraine

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuromed IRCCS

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.