The Integrative Migraine Pain Alleviation through Chiropractic Therapy (IMPACT) trial: Study rationale, design and intervention validation.
Chiropractic care
Complementary and integrative health
Episodic migraine
Pragmatic trial
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Mar 2020
Mar 2020
Historique:
received:
15
10
2019
revised:
06
01
2020
accepted:
19
01
2020
entrez:
12
2
2020
pubmed:
12
2
2020
medline:
12
2
2020
Statut:
epublish
Résumé
Approximately 15% of the US population experiences migraine, with women afflicted three times as often as men. While medications are often used as first-line treatments, up to 50% of people with migraine pursue complementary and integrative medicine. One promising non-pharmacological approach for migraine is chiropractic care, due to the co-occurrence of migraine disease and musculoskeletal tension and pain. To date, no large-scale trials have evaluated the impact of a comprehensive model of chiropractic care on migraine. The Integrative Migraine Pain Alleviation through Chiropractic Therapy (IMPACT) study is a two-arm pilot pragmatic randomized clinical trial evaluating a multimodal chiropractic care intervention plus enhanced usual care (UC) vs. enhanced UC alone for adult women with episodic migraine. A total of 60 women aged 20-55 who meet criteria for episodic migraine will be randomly assigned to an evidence-informed, musculoskeletal focused multimodal chiropractic care (10 sessions over 14 weeks) plus enhanced UC vs. enhanced UC alone. Enhanced UC includes conventional care, migraine education materials, and biweekly check-in phone calls. Study specific aims include: 1) Determine safety and feasibility of the study design; 2) Provide preliminary data on the effectiveness of chiropractic care on migraine frequency, severity, duration and medication use; and 3) Provide preliminary estimates of the effects of chiropractic care on disability, health-related quality of life, and psychosocial well-being. Findings will be used to inform the design of a full-scale trial evaluating chiropractic care for women with episodic migraines.
Identifiants
pubmed: 32043014
doi: 10.1016/j.conctc.2020.100531
pii: S2451-8654(20)30015-6
pii: 100531
pmc: PMC6997836
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100531Subventions
Organisme : NHLBI NIH HHS
ID : K01 HL128791
Pays : United States
Organisme : NCCIH NIH HHS
ID : K24 AT009282
Pays : United States
Informations de copyright
© 2020 The Authors. Published by Elsevier Inc.
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