Clinical trial NCT03177616: Integrative Migraine Pain Alleviation Through Chiropractic Therapy
Official title: Integrative Migraine Pain Alleviation Through Chiropractic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Migraine Disorders
Migraine With Aura
Migraine Without Aura
Migraine, Classic
Keywords: Migraine
Women
Adult
Feasibility
Safety
Pilot Randomized Trial
Randomized Control Trial
Chiropractic
Lead sponsor: Harvard University Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Palmer Center for Chiropractic Research (PCCR)
First posted: 2017-06-06
Enrollment: 61
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Chiropractic care is a commonly used therapeutic intervention for the treatment of pain disorders, and some smaller studies have shown that it might be helpful for migraines. This pilot study will use a comprehensive model of chiropractic treatment which can include soft tissue mobilization, spinal manipulation, and postural and spinal stabilization and correctional exercises.

Specific Aims:

Aim #1 - Determine the feasibility of conducting a randomized control trial (RCT) of chiropractic care in adult women with migraine.

Aim #2 - To provide preliminary data on the safety and effectiveness of chiropractic care on migraine frequency, severity, duration, and medication use in adult women with migraine.

Aim #3 - To provide preliminary estimates of the effects of chiropractic on disability, health-related quality of life, and psychosocial well-being.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of episodic migraine with or without aura (International Classification of Headache Disorders-II)
* 4 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline to the last four weeks of the intervention period in the number of migraine days.
timeFrame: From the baseline period to week 11 through week 14.
Secondary outcomes:
measure: Changes from baseline to the post-intervention period in the number of migraine days.
timeFrame: From the baseline period to week 15 through week 18.
measure: Number of responders
timeFrame: From the baseline period to week 11 through week 14 and to week 15 through week 18.
measure: Change from baseline in the severity of migraine
timeFrame: From the baseline period to week 11 through week 14 and to week 15 through week 18.
measure: Change from baseline in the duration of migraine
timeFrame: From the baseline period to week 11 through week 14 and to week 15 through week 18.
measure: Change from baseline in the doses of acute migraine medications used
timeFrame: From the baseline period to week 11 through week 14 and to week 15 through week 18.
measure: Change from baseline in the scores on the Headache Impact Test (HIT-6) questionnaire
timeFrame: From baseline to 14 weeks and 18 weeks
measure: Change from baseline in the scores on the Migraine Disability Assessment (MIDAS)
timeFrame: From baseline to 14 weeks and 18 weeks
measure: Change from baseline in the Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1)
timeFrame: From baseline to 14 weeks and 18 weeks
measure: Change from baseline in Numeric Rating Pain Scale (NRS)
timeFrame: From baseline to 14 weeks and 18 weeks
measure: Change from baseline in 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: From baseline to 14 weeks and 18 weeks
measure: Change from baseline in the Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: From baseline to 14 weeks and 18 weeks
measure: Change from baseline in the Patient Reported Outcome Measures Information System -29 item questionnaire (PROMIS-29)
timeFrame: From baseline to 14 weeks and 18 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: The Osher Clinical Center for Integrative Medicine at Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Peter Wayne, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.