NCT06229834 · Brigham and Women's Hospital
Chiropractic Care for Episodic Migraine
What this study is 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.
View original scientific description
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.
Interventions
PROCEDURE
Chiropractic Care
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.
BEHAVIORAL
Headache Health Education
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.
Primary outcome measures
Recruitment feasibility (average number of participants per month)
Time frame: 16 months
Each site will be able to recruit 30 participants within 16 months
Retention feasibility (proportion of participants not lost to follow-up)
Time frame: 20 weeks
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.
Intervention adherence feasibility
Time frame: 15 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Confirmed migraine frequency ≥4 to ≤13 days per month during a run-in period
- If use of medication is applicable, dose must be stable for 2 months prior to study enrollment
- If use of medication for non-migraine pain condition is applicable (with the exception of episodic tension type headache), dose must be stable for 2 months prior to study enrollment
- Willing and able to complete all study procedures and be randomized to either of the two intervention groups
- Fluency in English
- Confirmed access to and proficiency with use of a smartphone, computer, and/or tablet
- Working email address or willingness to create an email account for the study
Exclusion criteria
- 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)
- Used neuromodulation (i.e., "headache devices"), procedures for migraine prevention within the 2 months before the baseline period, or investigational medications or headache devices for at least 90 days prior to screening
- Diagnosis of medication overuse headache according to the ICHD-3 guidelines at the screening visit with the study physician
- Traumatic Brain Injury ≤ 1 year before screening visit or worsening of migraine as noted by the screening study physician
- Head or neck trauma within the past year causing neurological or musculoskeletal signs or symptoms requiring treatment
- Any medical, neurologic, or psychiatric condition that the screening study physician deems would lead to difficulty complying with the protocol or negatively impact the safety profile of the interventions
- Psychiatric hospitalization in the last 6 months
- Receiving hospice or palliative care
- History of carotid or vertebral artery dissection
- Presence of carotid bruits
- Presence of contraindications (relative or absolute) for spinal manipulation or mobilization where these procedures cannot be modified for safe administration and are consistent with those published by the World Health Organization (WHO) guidelines, including but not limited to:
- Local spinal hypermobility/instability
- Conditions causing general spinal hypermobility, such as Marfan, Ehlers-Danlos syndrome, and Osteogenesis imperfecta
- Malignancy of the spine or spinal cord
- Frank disc herniation with signs of progressive neurological deficit
- Spinal or intracanalicular hematomas Inflammatory spondyloarthropathies such as rheumatoid arthritis
- Spinal fractures or dislocations
- Avascular necrosis in an area of proposed joint manipulation
- Bone-weakening disorders affecting the spine, such as benign bone tumors, infection, or osteoporosis
- Vertebrobasilar insufficiency syndrome
- Aneurysm involving a major blood vessel in an area of potential joint manipulation
- History of stroke
- Anticoagulant therapy or blood disorders cause significant bleeding tendency
- Cervical spine congenital anomalies that affect the stability or neurologic integrity of the individual or history of cervical spine surgery
- Either self-reported current alcohol or substance use disorder or current alcohol or substance use disorder documented by a treating medical provider within the past 6 months
- Hormone replacement therapy for less than six months, or if prescriptions greater than 6 months in duration must be at a stable dose
- Significant cognitive impairment that would impair participation in the trial
- Currently pregnant or intention to become pregnant within the next six months
Where
- Boston, Massachusetts
Collaborators
Palmer College of Chiropractic, Yale University, VA Connecticut Healthcare System, National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations