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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05226559
Other study ID # MIGRA012021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 24, 2022
Est. completion date May 2025

Study information

Verified date February 2024
Source Neuromed IRCCS
Contact Armando Perrotta, MD
Phone 3394007593
Email arm.perrotta@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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.

Locations

Country Name City State
Italy IRCCS Neuromed Pozzilli Isernia

Sponsors (1)

Lead Sponsor Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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) Migraine disability assessment score (MIDAS) The scale ranges between 0 "little or no disability" and 5 "severe disability" 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 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) Neck disability index (NDI) Each of the 10 items is scored from 0 - 5. The score between 0 and 4 indicates "no disability", the score above 34 indicates a severe disability 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 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) Patient Health Questionnaire-9 (PHQ-9) The score between 0 and 4 indicates "none depression", the maximum score between 20 and 27 indicates a severe depression 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)
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