RecruitingNot applicable

Chiropractic Care for Episodic Migraine

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 14 visits, 6 visits, 8 visits
  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "We will recruit and randomize 60 individuals (30 per site) to either 1) 14 visits of chiropractic care (CC) (6 visits of CC over 3-5 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests chiropractic care for migraines that happen on some days, rather than chronic migraines. It is for adults ages 18–65 who have had migraines for at least one year and have 4–13 migraine days a month. The results will help plan a larger study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–65 years old.
  • Have migraines confirmed by the study doctor, with or without aura (warning signs such as flashing lights), but not chronic migraines.
  • Have had migraines for at least one year, with 4–13 migraine days a month during the starting period.
  • Fill out a headache diary on at least 26 of 28 days.
  • If taking medicine, have a stable dose for 2 months before joining. This also applies to medicine for other pain, except occasional tension headaches.
  • Be willing and able to finish all study tasks and be assigned by chance to either study group.
  • Be fluent in English.
  • Have access to and know how to use a smartphone, computer, or tablet. Have an email address or be willing to create one.

Who can't join

  • Not be a Veteran, if joining at the Veterans Affairs Medical Center site.
  • Have had Botox for head or neck pain in the past 4 months, or chiropractic care or behavioral treatments such as mindfulness or relaxation in the past 3 months.
  • Have used headache devices or migraine-prevention procedures in the 2 months before the starting period, or study drugs or headache devices in the 90 days before screening.
  • Have headaches from using too much medicine; a brain injury within the past year or worsening migraines; or a head or neck injury in the past year with symptoms needing treatment.
  • Have a condition the study doctor believes makes participation unsafe or difficult, major thinking or memory problems, a mental health hospital stay in the past 6 months, current alcohol or drug use disorder, or hospice or palliative care.
  • Have a history of a tear in a major neck artery, an unusual sound from blood flow in a neck artery, or conditions that make spinal treatment unsafe. Examples include unstable or weak spine bones, spine cancer or injury, worsening nerve damage, poor blood flow to the brain, stroke, bleeding risks, or past neck spine surgery.
  • Have used hormone replacement therapy for less than 6 months, or have used it longer without a stable dose.
  • Be pregnant or plan to become pregnant within the next 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MA