Integrative Migraine Pain Alleviation Through Chiropractic Therapy (IMPACT)

Harvard University Faculty of Medicine

Status: Completed

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

Treatments: Other: Chiropractic Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03177616

2017P000087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Female

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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.

Chiropractic Treatment + Usual Care

Experimental group

Description:

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.

Treatment:

Other: Chiropractic Treatment