Episodic Migraine study: Chiropractic Care vs Headache Health Education
Official title Chiropractic Care for Episodic Migraine
ClinicalTrials.gov ID: NCT06229834
What this study is testing
- What it's testing
- This study is testing whether chiropractic care can reduce migraine attacks in people with episodic migraine.
- Who it's for
- You may be able to join if you have episodic migraine.
- What's involved
- You would receive chiropractic treatments, such as gentle spinal adjustments, during study visits.
- Time commitment
- The study lasts a few weeks and includes several in‑person visits.
- Time commitment: about 12 weeks
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Used neuromodulation (i.e., "headache devices"), procedures for migraine prevention within the 2 months before the baseline period, or...
- Diagnosis of medication overuse headache according to the ICHD-3 guidelines at the screening visit with the study physician
See the full eligibility criteria
Who can join
- 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...
- 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 assigned by chance 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
What rules you out
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.