Chiropractic Care for Episodic Migraine

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Mass General Brigham

Status

Not yet enrolling

Conditions

Episodic Migraine

Treatments

Procedure: Chiropractic Care
Behavioral: Headache Health Education

Study type

Interventional

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT06229834
R01AT012228-01 (U.S. NIH Grant/Contract)
2023P003554

Details and patient eligibility

About

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.

Full description

Migraine, a chronic intermittent headache disorder, ranks in the top five causes for years lived with disability. Due to the high disability burden associated with migraine, individuals who experience migraine often seek treatments to reduce the frequency and severity of their attacks and often express interest in nonpharmacologic and integrative approaches. One promising treatment may be chiropractic care due to the comorbidity of migraine and musculoskeletal complaints. Our long-term goal is to conduct a multi-site large-scale, fully powered trial evaluating the effectiveness of a validated multimodal chiropractic care intervention to reduce migraine frequency, severity, and disability. To help inform the design of a large-scale trial with both pragmatic and explanatory features, we propose to conduct a two-arm pilot randomized attention-controlled trial at two sites which are representative of sites to be included in the future large-scale trial. We will recruit and randomize 60 individuals (30 per site) to either 1) 14 visits of chiropractic care (CC) (6 visits of CC over 3 weeks followed by 8 visits of CC over 12 weeks); or 2) 14 sessions of headache health education (15-minute 1:1 virtual sessions focused on pre-defined migraine specific topics) - both added to usual medical care. This study will allow us to address the following aims: 1) To train a team of chiropractors from established clinics within two academic medical centers with existing partnerships with headache programs, refine our intervention, and assess the fidelity of intervention protocols; 2) To optimize data collection, data management, and reporting procedures across sites and establish the infrastructure needed for a large-scale trial; 3) To assess the feasibility of recruitment, retention, and adherence across multiple study sites; 4) To assess participant expectations and treatment experience.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Migraine frequency between 4 to 13 days per month during a four week run-in period, and with a history of migraines dating for at least one year;
  • Stable use of behavioral interventions or, if not currently using behavioral interventions, agree to not begin new behavioral interventions during this trial;
  • Be willing to complete all study procedures and be randomized to all intervention groups;
  • Be fluent in English.

Exclusion criteria

  • Any major systemic illness or unstable medical condition (e.g. Parkinson's disease, cancer) or psychiatric condition requiring immediate treatment or that could lead to difficulty complying with the protocol;
  • History of stroke, carotid artery dissection, or vertebral artery dissection;
  • Signs of myelopathy or carotid bruits or evidence of hypermobility during the clinical exam;
  • Head or neck trauma within the past year;
  • Current alcohol or substance abuse (self-reported);
  • Diagnosis of medication overuse headache (International 3rd Classification of Headache Disorders-edition);
  • Currently or recently (past 6 months) received Botox treatment for migraine;
  • Currently or recently received chiropractic care (past 3 months) for any condition;
  • Failure to complete baseline migraine logs use during run-in phase.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Chiropractic Care
Experimental group
Description:
4 sessions of chiropractic care (6 sessions of chiropractic care over 3 weeks followed by 8 sessions of chiropractic care over 12 weeks); participants will be allowed to continue usual care throughout the study.
Treatment:
Procedure: Chiropractic Care
Headache Health Education (HHE)
Other group
Description:
Participants randomized to Headache Health Education (HHE) will receive 14 interactive 15-minute education sessions delivered via videoconference.
Treatment:
Behavioral: Headache Health Education

Trial contacts and locations

0

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Central trial contact

Dennis Muñoz-Vergara, PhD; Pamela M Rist, ScD

Data sourced from clinicaltrials.gov

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