Integrative Migraine Pain Alleviation Through Chiropractic Therapy
IMPACT
1 other identifier
interventional
61
1 country
1
Brief Summary
This pilot study evaluates the addition of chiropractic treatment to conventional neurological care in the treatment of migraine headaches in adult women. Half of the participants will receive 10 chiropractic treatments in addition to their usual care over a 14 week period, while the other half will continue their usual medical care alone, as prescribed by their physician during that time period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedStudy Start
First participant enrolled
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2022
CompletedMarch 3, 2023
March 1, 2023
2.1 years
May 31, 2017
March 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to the last four weeks of the intervention period in the number of migraine days.
Participants will record number of migraines experienced in provided logs.
From the baseline period to week 11 through week 14.
Secondary Outcomes (12)
Changes from baseline to the post-intervention period in the number of migraine days.
From the baseline period to week 15 through week 18.
Number of responders
From the baseline period to week 11 through week 14 and to week 15 through week 18.
Change from baseline in the severity of migraine
From the baseline period to week 11 through week 14 and to week 15 through week 18.
Change from baseline in the duration of migraine
From the baseline period to week 11 through week 14 and to week 15 through week 18.
Change from baseline in the doses of acute migraine medications used
From the baseline period to week 11 through week 14 and to week 15 through week 18.
- +7 more secondary outcomes
Study Arms (2)
Usual Care
NO INTERVENTIONSubjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician. They are not to use any chiropractic treatment or begin new therapies.
Chiropractic Treatment + Usual Care
EXPERIMENTALPatients will receive a course of 10 chiropractic treatments over a 14 week period. They are to also maintain their usual medical care as prescribed by their physician, but are not to begin any new therapies.
Interventions
The treatment plan will be customized to the patient's needs. The chiropractic interventions are summarized as follows: * posture correction/spinal stabilization exercises * soft tissue relaxation techniques * spinal manipulation (i.e. chiropractic adjustment)/mobilization * breathing and relaxing techniques * stretches, self-care * ergonomic modifications * bracing and supports
Eligibility Criteria
You may qualify if:
- Diagnosis of episodic migraine with or without aura (International Classification of Headache Disorders-II)
- to 13 days with migraines/month
- More than one year of migraines
- Agreeable to participate, commit to all study procedures, and to be randomized to either group
- Fluent in English (required to complete self-report instruments)
You may not qualify if:
- Currently, or having received chiropractic care in past 3 months for any condition
- Any major systemic illness or unstable medical or psychiatric condition (e.g. Parkinson's disease, cancer) requiring immediate treatment or that could lead to difficulty complying with the protocol
- History of stroke, carotid artery dissection, or vertebral artery dissection
- Head or neck trauma within the past year
- Diagnosis of medication overuse headache (International Classification of Headache Disorders-II)
- Began use of new prophylactic medication for migraine headaches within the last 3 months
- Currently taking prophylactic migraine medications other than propranolol and topiramate
- Failure to complete baseline diary recordings of migraine activity and medication use during run-in phase
- Currently, or having received Botox treatment for migraine
- Current alcohol or substance abuse (self-reported)
- Diagnosis of Ehlers-Danlos Syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard University Faculty of Medicinelead
- Brigham and Women's Hospitalcollaborator
- Palmer Center for Chiropractic Research (PCCR)collaborator
Study Sites (1)
The Osher Clinical Center for Integrative Medicine at Brigham and Women's Hospital
Boston, Massachusetts, 02467, United States
Related Publications (1)
Rist PM, Bernstein C, Kowalski M, Osypiuk K, Connor JP, Vining R, Long CR, Macklin EA, Wayne PM. Multimodal chiropractic care for migraine: A pilot randomized controlled trial. Cephalalgia. 2021 Mar;41(3):318-328. doi: 10.1177/0333102420963844. Epub 2020 Oct 13.
PMID: 33050719DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Wayne, Ph.D.
Harvard Medical School (HMS and HSDM)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
May 31, 2017
First Posted
June 6, 2017
Study Start
June 7, 2017
Primary Completion
July 12, 2019
Study Completion
November 4, 2022
Last Updated
March 3, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share