Effectiveness of Multimodal Physical Therapy in Migraine

NCT05226559 | Recruiting

• 1 other identifier: MIGRA012021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Migraine;; Chronic Migraine;; Physical Therapy;; Cervical musculoskeletal dysfunction;; Joint Dysfunction;; trigger point

Outcome Measures

Primary Outcomes (2)

• 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)

  Number of monthly migraine days

  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)

  Monthly migraine days with use of acute medication

  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)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Multimodal Physical therapy approach plus usual care

ACTIVE COMPARATOR

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

Procedure: Multimodal Physical therapy approach plus usual care; Drug: Usual care

Usual care

NO INTERVENTION

Standard pharmacological treatment alone

Interventions

Multimodal Physical therapy approach plus usual care PROCEDURE

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

Also known as: Intervention group

Multimodal Physical therapy approach plus usual care

Usual care DRUG

Standard pharmacological treatment alone.

Also known as: Usual care group

Multimodal Physical therapy approach plus usual care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS Neuromed

Pozzilli, Isernia, 86077, Italy

RECRUITING

Related Publications (5)

• Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

  PMID: 29368949 BACKGROUND

• Ashina S, Bendtsen L, Lyngberg AC, Lipton RB, Hajiyeva N, Jensen R. Prevalence of neck pain in migraine and tension-type headache: a population study. Cephalalgia. 2015 Mar;35(3):211-9. doi: 10.1177/0333102414535110. Epub 2014 May 22.

  PMID: 24853166 BACKGROUND

• Florencio LL, Chaves TC, Carvalho GF, Goncalves MC, Casimiro EC, Dach F, Bigal ME, Bevilaqua-Grossi D. Neck pain disability is related to the frequency of migraine attacks: a cross-sectional study. Headache. 2014 Jul-Aug;54(7):1203-10. doi: 10.1111/head.12393. Epub 2014 May 26.

  PMID: 24863346 BACKGROUND

• Luedtke K, Starke W, May A. Musculoskeletal dysfunction in migraine patients. Cephalalgia. 2018 Apr;38(5):865-875. doi: 10.1177/0333102417716934. Epub 2017 Jun 22.

  PMID: 28641450 BACKGROUND

• Bartsch T, Goadsby PJ. The trigeminocervical complex and migraine: current concepts and synthesis. Curr Pain Headache Rep. 2003 Oct;7(5):371-6. doi: 10.1007/s11916-003-0036-y.

  PMID: 12946290 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Joint Diseases

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases

Study Officials

• Armando Perrotta, MD

  Neuromed IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armando Perrotta, MD

CONTACT

3394007593; arm.perrotta@gmail.com

Luciano D'Ambrosio, PT

CONTACT

3282292254; luciano.dambrosio89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Physiotherapists are blinded toward the diagnosis and outcome measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, parallel group, randomized clinical trial.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 7, 2022
• Study Start: February 24, 2022
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)