Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT06229834
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06229834
Study Brief:
Protocol Section:
NCT06229834