Integrative Migraine Pain Alleviation Through Chiropractic Therapy

Harvard University Faculty of Medicine61 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Migraine Migraine Disorders

Interventions

Chiropractic TreatmentOTHER

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

Sex: FEMALEMin age: 20 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: From the baseline period to week 11 through week 14.

Secondary Outcomes

Changes from baseline to the post-intervention period in the number of migraine days.

Participants will record number of migraines experienced in provided logs for four weeks post-intervention.

Time frame: From the baseline period to week 15 through week 18.

Number of responders

Participants who had a greater than 50% reduction in days with migraine per four week period.

Time frame: 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

Participants will record the severity of migraines on a scale of 1 to 10 in provided logs.

Time frame: 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

Participants will record the duration (hours) of migraines in provided logs.

Time frame: 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

Participants will record the medications taken to treat/prevent their migraines in provided logs.

Time frame: From the baseline period to week 11 through week 14 and to week 15 through week 18.

Change from baseline in the scores on the Headache Impact Test (HIT-6) questionnaire

The HIT-6 questionnaire evaluates headache related disability.