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MigraineIMPACTNCT03177616

Integrative Migraine Pain Alleviation Through Chiropractic Therapy

A study testing Chiropractic Treatment in people with Migraine and Migraine Disorders, run by Harvard University Faculty of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 55 years, women only
Conditions the study is for
Migraine, Migraine Disorders, Migraine With Aura
What is being tested?
Chiropractic Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
7 Jun 2017to 4 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Boston, Massachusetts, 02467

Other trials in United States

About this study

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.

Read the 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.

Being tested
Chiropractic Treatment
Keywords
Migraine, Women, Adult, Feasibility, Safety, Pilot Randomized Trial, Randomized Control Trial, Chiropractic
Medical subject headings
Migraine Disorders, Migraine with Aura, Migraine without Aura

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chiropractic TreatmentOther

    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
Study groups in NCT03177616
Study groupRoleWhat they receive
Usual CareNo interventionSubjects 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.
Chiropractic Treatment + Usual CareExperimentalPatients 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.
Receives: Other: Chiropractic Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From the baseline period to week 11 through week 14.

Secondary outcomes (12)

  1. 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.

    Measured: From the baseline period to week 15 through week 18.

  2. Number of responders

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

    Measured: From the baseline period to week 11 through week 14 and to week 15 through week 18.

  3. 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.

    Measured: From the baseline period to week 11 through week 14 and to week 15 through week 18.

  4. Change from baseline in the duration of migraine

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

    Measured: From the baseline period to week 11 through week 14 and to week 15 through week 18.

  5. 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.

    Measured: From the baseline period to week 11 through week 14 and to week 15 through week 18.

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

    The HIT-6 questionnaire evaluates headache related disability.

    Measured: From baseline to 14 weeks and 18 weeks

  7. 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.

    Measured: From baseline to 14 weeks and 18 weeks

  8. 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.

    Measured: From baseline to 14 weeks and 18 weeks

  9. 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.

    Measured: From baseline to 14 weeks and 18 weeks

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

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

    Measured: From baseline to 14 weeks and 18 weeks

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

    The GAD-7 will be used to measure changes in mood.

    Measured: From baseline to 14 weeks and 18 weeks

  12. 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.

    Measured: From baseline to 14 weeks and 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2017
  2. Study start7 Jun 2017
  3. Primary completion12 Jul 2019
  4. Study completion4 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03177616
Sponsor's protocol ID
2017P000087
Acronym
IMPACT
Status last verified
Mar 2023
First submitted
31 May 2017
Last updated
3 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rist PM, Bernstein C, Kowalski M, Osypiuk K, Connor JP, Vining R, Long CR, Macklin EA, Wayne PM. Multimodal chiropractic care for migraine: A pilot randomized controlled trial. Cephalalgia. 2021 Mar;41(3):318-328. doi: 10.1177/0333102420963844. Epub 2020 Oct 13.

    PubMed 33050719

Questions about this trial

What is this clinical trial studying?

A study testing Chiropractic Treatment in people with Migraine and Migraine Disorders, run by Harvard University Faculty of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03177616, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.

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