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Integrative Migraine Pain Alleviation Through Chiropractic Therapy (IMPACT)

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ClinicalTrials.gov Identifier: NCT03177616
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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
Migraine Migraine Disorders Migraine With Aura Migraine Without Aura Migraine, Classic Other: Chiropractic Treatment

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  (Clinical Trial)
Estimated Enrollment : 60 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 : June 7, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in the number of migraine days per month [ Time Frame: From baseline to 10 weeks and 14 weeks ]
    Participants will record number of migraines experienced in provided logs.


Secondary Outcome Measures :
  1. Changes from baseline in the number of migraine days per month during post-intervention period [ Time Frame: From 14 weeks to 18 weeks ]
    Participants will record number of migraines experienced in provided logs for one month post-intervention.

  2. Number of responders [ Time Frame: From baseline to 10 weeks, 14 weeks, and 18 weeks ]
    Participants who had a greater than 50% reduction in days per month with migraine.

  3. Change from baseline in the severity of migraine [ Time Frame: From baseline to 14 weeks and 18 weeks ]
    Participants will record the severity of migraines on a scale of 1 to 10 in provided logs.

  4. Change from baseline in the duration of migraine [ Time Frame: From baseline to 14 weeks and 18 weeks ]
    Participants will record the duration (hours) of migraines in provided logs.

  5. Change from baseline in the doses of acute migraine medications used [ Time Frame: From baseline to 14 weeks and 18 weeks ]
    Participants will record the medications taken to treat/prevent their migraines in provided logs.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of episodic migraine with or without aura (International Classification of Headache Disorders-II)
  • 4 to 10 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)
  • Being on prophylactic treatment for migraine headache
  • 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177616


Contacts
Contact: Audrey J Hernandez, M.S. 617-732-6508 ahernandez24@partners.org

Locations
United States, Massachusetts
The Osher Clinical Center for Integrative Medicine at Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02467
Contact: Audrey Hernandez    617-732-6508    ahernandez24@partners.org   
Sponsors and Collaborators
Harvard University Faculty of Medicine
Brigham and Women's Hospital
Palmer Center for Chiropractic Research
Investigators
Principal Investigator: Peter Wayne, Ph.D. Harvard Medical School
More Information

Responsible Party: Peter Wayne, Associate Professor of Medicine, Harvard University Faculty of Medicine
ClinicalTrials.gov Identifier: NCT03177616     History of Changes
Other Study ID Numbers: 2017P000087
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter Wayne, Harvard University Faculty of Medicine:
Migraine
Women
Adult
Feasibility
Safety
Pilot Randomized Trial
Randomized Control Trial
Chiropractic

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases