Health TrialsbyHealthPanel

Chiropractic Care for Episodic Migraine

ConditionEpisodic Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital

About this trial

Migraine, a chronic intermittent headache disorder, ranks in the top five causes of years lived with disability. One promising non-pharmacologic and integrative treatment for migraine may be chiropractic care due to the co-occurrence of migraine and musculoskeletal complaints. The goal of this application is to perform a pilot study of chiropractic care for episodic migraine to help inform the design of a future, full-scale pragmatic effectiveness trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years

Confirmed diagnosis of migraine with or without aura which does not meet criteria for chronic migraine according to the International Classification for -Headache Disorders (ICHD)-3 guidelines at the screening visit with the study physician

History of migraines dating for at least one year

Completion of at least 26 headache diary days out of 28

Disqualifiers

Non-Veterans (VAMC only)

Received botulinum toxin treatment for headache and/or neck pain within the 4 months prior to the start of the baseline phase

Received chiropractic care for any condition within the 3 months prior to the start of the baseline phase

Received behavioral interventions (e.g., cognitive behavioral therapy, acceptance and commitment therapy, mindfulness, relaxation techniques, hypnosis) within the past 3 months)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chiropractic Care

    Procedure/Surgery

    The chiropractic care protocol can be personalized to the patient's clinical needs and follows the scope of chiropractic care practice in the Commonwealth of Massachusetts and the State of Connecticut. Components of the chiropractic intervention include: posture correction / spinal stabilization exercises; soft tissue relaxation techniques; spinal manipulation (i.e. chiropractic adjustment) / mobilization; breathing and relaxation techniques; stretches, self-care; ergonomic modifications; bracing and supports.

  • Headache Health Education

    Behavioral

    Participants randomized to the HHE arm will receive 14 interactive 15-minute education sessions delivered via video conference. To partially control for attention and expectation associated with chiropractic care, participants randomized to the control group will receive a modified version of a headache education intervention we employed in our pilot study. Participants randomized to HHE will receive 14 interactive 15-minute education sessions delivered via VA or MGB Teams. Material to be covered will focus on pre-defined migraine-specific topics, compared with the control for our pilot study, in addition to greater contact time, HHE will be delivered in a more interactive manner utilizing active learning principles known to support adult learning. We will also utilize publicly available short videos (e.g., from the American Headache Society) followed by scripted discussions with the participant. Example topics include the physiology of migraine or the contribution of life.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Chiropractic CareExperimental treatment 1 intervention
Group B: Headache Health Education (HHE)Other 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment feasibility (average number of participants per month)

Each site will be able to recruit 30 participants within 16 months

Time frame
16 months
2

Retention feasibility (proportion of participants not lost to follow-up)

Retention will be quantified by the proportion of subjects who record their migraines for at least 26 out of 28 days and all questionnaires at each outcome assessment.

Time frame
20 weeks
3

Intervention adherence feasibility

Adherence will be calculated as the proportion of subjects who attend at least 80% of the chiropractic care visits or 80% of the one-on-one headache health education video-conferences.

Time frame
15 weeks

Secondary outcomes

1

Number of days with migraine headaches

Number of migraine headaches as recorded in migraine diaries.

Time frame
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
2

Proportion of responders

Proportion of individuals who experience a ≥50% reduction in migraine days.

Time frame
Change from baseline to initial follow-up (16 weeks) and change from baseline to final follow-up (20 weeks).
3

Average severity of migraine attacks

Average severity of migraine attacks (on a 1 to 10 scale) as recorded in migraine diaries.

Time frame
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
4

Average number of hours for a migraine attack (duration)

Average number of hours a migraine attack lasted as recorded in migraine diaries.

Time frame
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Palmer College of Chiropractic

Collaborator

Yale University

Collaborator

VA Connecticut Healthcare System

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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