Integrative Migraine Pain Alleviation Through Chiropractic Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrative Migraine Pain Alleviation Through Chiropractic Therapy

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

Intervention / Treatment
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* Other: Chiropractic Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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. | |
| Experimental: Chiropractic Treatment + Usual Care<br>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. | Other: Chiropractic Treatment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | From baseline to 14 weeks and 18 weeks | 
| Change from baseline in the scores on the Migraine Disability Assessment (MIDAS) | The MIDAS is a 5-item questionnaire used to assess disability in migraine research. | From baseline to 14 weeks and 18 weeks | 
| Change from baseline in the Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) | The MSQv2.1 measures how migraines affect a patient's daily life. | From baseline to 14 weeks and 18 weeks | 
| Change from baseline in Numeric Rating Pain Scale (NRS) | The NRS tool will be used to measure neck pain on a scale from 1 to 10. | From baseline to 14 weeks and 18 weeks | 
| Change from baseline in 9-item Patient Health Questionnaire (PHQ-9) | The PHQ-9 will be used to measure changes in mood. | From baseline to 14 weeks and 18 weeks | 
| Change from baseline in the Generalized Anxiety Disorder 7-item (GAD-7) | The GAD-7 will be used to measure changes in mood. | From baseline to 14 weeks and 18 weeks | 
| Change from baseline in the Patient Reported Outcome Measures Information System -29 item questionnaire (PROMIS-29) | The PROMIS-29 will be used to measure changes in mood. | From baseline to 14 weeks and 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Women, Adult, Feasibility, Safety, Pilot Randomized Trial, Randomized Control Trial, Chiropractic