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Effectiveness of Multimodal Physical Therapy in Migraine

NCT05226559 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

  • Migraine
  • Musculoskeletal Neck Pain
  • Musculoskeletal Disorder of the Neck
  • Chronic Migraine
  • Episodic Migraine

Interventions

PROCEDURE

Multimodal Physical therapy approach plus usual care

HVLA spinal manipulation, mobilization, soft tissue treatment, therapeutic exercise, education, plus standard pharmacological treatment.

DRUG

Usual care

Standard pharmacological treatment alone.

Sponsors & Collaborators

  • Neuromed IRCCS

    lead OTHER

Principal Investigators

  • Armando Perrotta, MD · Neuromed IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2024-12-31
Completion
2025-05-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226559 on ClinicalTrials.gov