Integrative Migraine Pain Alleviation Through Chiropractic Therapy

NCT ID: NCT03177616

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-07
• Study Completion Date: 2022-11-04

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.

Conditions

Migraine; Migraine Disorders; Migraine With Aura; Migraine Without Aura; Migraine, Classic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Subjects 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Chiropractic Treatment + Usual Care

Patients 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.

Group Type: EXPERIMENTAL

Chiropractic Treatment

Intervention Type: OTHER

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

Interventions

Chiropractic Treatment

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Palmer Center for Chiropractic Research (PCCR)

OTHER

Sponsor Role: collaborator

Harvard University Faculty of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Peter Wayne

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Wayne, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Locations

The Osher Clinical Center for Integrative Medicine at Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33050719 (View on PubMed)

Other Identifiers

2017P000087

Identifier Type: -

Identifier Source: org_study_id