Integrative Migraine Pain Alleviation Through Chiropractic Therapy (IMPACT)

March 2, 2023 updated by: Peter Wayne, Harvard University Faculty of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02467
        • The Osher Clinical Center for Integrative Medicine at Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline to the last four weeks of the intervention period in the number of migraine days.
Time Frame: From the baseline period to week 11 through week 14.
Participants will record number of migraines experienced in provided logs.
From the baseline period to week 11 through week 14.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from baseline to the post-intervention period in the number of migraine days.
Time Frame: 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.
From the baseline period to week 15 through week 18.
Number of responders
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: From baseline to 14 weeks and 18 weeks
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)
Time Frame: From baseline to 14 weeks and 18 weeks
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)
Time Frame: From baseline to 14 weeks and 18 weeks
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)
Time Frame: 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.
From baseline to 14 weeks and 18 weeks
Change from baseline in 9-item Patient Health Questionnaire (PHQ-9)
Time Frame: From baseline to 14 weeks and 18 weeks
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)
Time Frame: From baseline to 14 weeks and 18 weeks
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)
Time Frame: From baseline to 14 weeks and 18 weeks
The PROMIS-29 will be used to measure changes in mood.
From baseline to 14 weeks and 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard University Faculty of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brigham and Women's Hospital
Palmer Center for Chiropractic Research (PCCR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Wayne, Ph.D., Harvard Medical School (HMS and HSDM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017P000087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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