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NCT Number: NCT03177616

Integrative Migraine Pain Alleviation Through Chiropractic Therapy

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine With Aura Migraine Without Aura Migraine, Classic Nervous System Diseases

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chiropractic treatment

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  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.

Sponsors and collaborators

Lead sponsor

Harvard University Faculty of Medicine

Other

Collaborators

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

Registry information

Acronym: IMPACT

Important dates

Study start
2017
Primary completion
2019
Study completion
2022
First posted
Jun 6, 2017
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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