IMPACT: Integrative Migraine Pain Alleviation Through Chiropractic Therapy

Sponsor

Harvard University Faculty of Medicine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03177616

Collaborator

Brigham and Women's Hospital (Other), Palmer Center for Chiropractic Research (PCCR) (Other)

Enrollment

Location

Arms

62.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Migraine Disorders Migraine With Aura Migraine Without Aura Migraine, Classic	Other: Chiropractic Treatment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Integrative Migraine Pain Alleviation Through Chiropractic Therapy

Actual Study Start Date :

Jun 7, 2017

Actual Primary Completion Date :

Jul 12, 2019

Anticipated Study Completion Date :

Aug 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	Other: 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

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: 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.

Other: 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

Outcome Measures

Primary Outcome Measures

Change from baseline to the last four weeks of the intervention period in the number of migraine days. [From the baseline period to week 11 through week 14.]
Participants will record number of migraines experienced in provided logs.

Secondary Outcome Measures

Changes from baseline to the post-intervention period in the number of migraine days. [From the baseline period to week 15 through week 18.]
Participants will record number of migraines experienced in provided logs for four weeks post-intervention.
Number of responders [From the baseline period to week 11 through week 14 and to week 15 through week 18.]
Participants who had a greater than 50% reduction in days with migraine per four week period.
Change from baseline in the severity of migraine [From the baseline period to week 11 through week 14 and to week 15 through week 18.]
Participants will record the severity of migraines on a scale of 1 to 10 in provided logs.
Change from baseline in the duration of migraine [From the baseline period to week 11 through week 14 and to week 15 through week 18.]
Participants will record the duration (hours) of migraines in provided logs.
Change from baseline in the doses of acute migraine medications used [From the baseline period to week 11 through week 14 and to week 15 through week 18.]
Participants will record the medications taken to treat/prevent their migraines in provided logs.
Change from baseline in the scores on the Headache Impact Test (HIT-6) questionnaire [From baseline to 14 weeks and 18 weeks]
The HIT-6 questionnaire evaluates headache related disability.
Change from baseline in the scores on the Migraine Disability Assessment (MIDAS) [From baseline to 14 weeks and 18 weeks]
The MIDAS is a 5-item questionnaire used to assess disability in migraine research.
Change from baseline in the Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) [From baseline to 14 weeks and 18 weeks]
The MSQv2.1 measures how migraines affect a patient's daily life.
Change from baseline in Numeric Rating Pain Scale (NRS) [From baseline to 14 weeks and 18 weeks]
The NRS tool will be used to measure neck pain on a scale from 1 to 10.
Change from baseline in 9-item Patient Health Questionnaire (PHQ-9) [From baseline to 14 weeks and 18 weeks]
The PHQ-9 will be used to measure changes in mood.
Change from baseline in the Generalized Anxiety Disorder 7-item (GAD-7) [From baseline to 14 weeks and 18 weeks]
The GAD-7 will be used to measure changes in mood.
Change from baseline in the Patient Reported Outcome Measures Information System -29 item questionnaire (PROMIS-29) [From baseline to 14 weeks and 18 weeks]
The PROMIS-29 will be used to measure changes in mood.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts 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