Integrative Migraine Pain Alleviation Through Chiropractic Therapy

Migraine Clinical Trial

— IMPACT  

Official title:

Integrative Migraine Pain Alleviation Through Chiropractic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177616
• Other study ID #: 2017P000087
• Status: Completed
• Phase: N/A
• Start date: June 7, 2017
• Est. completion date: November 4, 2022

Study information

• Verified date: March 2023
• Source: Harvard University Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 4, 2022
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura
• Migraine, Classic

Intervention

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

Locations

Country	Name	City	State
United States	The Osher Clinical Center for Integrative Medicine at Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Harvard University Faculty of Medicine	Brigham and Women's Hospital, Palmer Center for Chiropractic Research (PCCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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