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Integrative Migraine Pain Alleviation Through Chiropractic Therapy (IMPACT)

Primary Purpose

Migraine, Migraine Disorders, Migraine With Aura

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Chiropractic Treatment

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Women, Adult, Feasibility, Safety, Pilot Randomized Trial, Randomized Control Trial, Chiropractic

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleDoes not accept 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

Sites / Locations

The Osher Clinical Center for Integrative Medicine at Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Chiropractic Treatment + Usual Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Number of responders

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

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.

Change from baseline in the duration of migraine

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

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.

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

The HIT-6 questionnaire evaluates headache related disability.

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.

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.

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.

Change from baseline in 9-item Patient Health Questionnaire (PHQ-9)

The PHQ-9 will be used to measure changes in mood.

Change from baseline in the Generalized Anxiety Disorder 7-item (GAD-7)

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)

The PROMIS-29 will be used to measure changes in mood.

Full Information

NCT ID

NCT03177616

First Posted

May 31, 2017

Last Updated

March 2, 2023

Sponsor

Harvard University Faculty of Medicine

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03177616

Brief Title

Integrative Migraine Pain Alleviation Through Chiropractic Therapy

Acronym

IMPACT

Official Title

Integrative Migraine Pain Alleviation Through Chiropractic Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

June 7, 2017 (Actual)

Primary Completion Date

July 12, 2019 (Actual)

Study Completion Date

November 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harvard University Faculty of Medicine

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Migraine, Women, Adult, Feasibility, Safety, Pilot Randomized Trial, Randomized Control Trial, Chiropractic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Arm Title

Chiropractic Treatment + Usual Care

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Chiropractic Treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline to the last four weeks of the intervention period in the number of migraine days.

Description

Participants will record number of migraines experienced in provided logs.

Time Frame

From the baseline period to week 11 through week 14.

Secondary Outcome Measure Information:

Title

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

Description

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.

Title

Number of responders

Description

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.

Title

Change from baseline in the severity of migraine

Description

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.

Title

Change from baseline in the duration of migraine

Description

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.

Title

Change from baseline in the doses of acute migraine medications used

Description

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.

Title

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

Description

The HIT-6 questionnaire evaluates headache related disability.

Time Frame