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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT01980927
Eligibility Criteria:
Inclusion Criteria:
* Patients must be 18-65 years of age.
* Be naive to Upper Cervical Chiropractic care. Other forms of chiropractic care in the past are permitted.
* Have migraine with or without aura.
* Have between 10-26 headache days per month over the last 4 months.
* Have at least 4 separate headache episodes per month, with episodes separated by at least 4 hours of painfree time.
* Have at least 8 days per month with pain of levels greater than or equal to 4/10 for part of the day, or have attacks successfully treated with migraine specific medication.
* Be candidates suitable for NUCCA therapeutic intervention because of atlas displacement as assessed by NUCCA investigator.
* Subjects on acceptable pharmacological prophylaxis must either remain on a stable dose throughout the study, or stop the prophylactic medication one month before entering the baseline period.
Exclusion Criteria:
* Any medical or psychiatric condition which in the opinion of the investigator would make the subject unsuitable for enrolment, because of inability to comply with study requirements or possible confounding of the results.
* Headache on more than 26 days per month.
* Acute medication overuse as defined by the International Classification of Headache Disorders.
* Pregnancy or lactation
* Severe cervical spine degeneration as assessed by cervical spine x-ray.
* Claustrophobia or any condition that contraindicates an MRI scan
* A history of cardiovascular disease, cerebrovascular disease, brain surgery, or other central nervous system disorder.
* Other chronic pain disorder which might interfere with headache assessment or study procedures.
* A history of significant hypo- or hypertension as determined by the investigator.
* Subject on a beta-blocker, calcium channel blocker, or other medication which the investigator considers might alter cerebral vascular regulation. Triptans are allowed, but must not be taken within 24 hours (48 hours for frovatriptan) before an MRI study.
* A history of substance abuse or dependence within 1 year.
* Current participation in a research study or within the last 30 days.
* Any spinal chiropractic care outside of the study protocol is prohibited during the baseline and treatment period.
* Use of botulinum A within 4 months of study entry.
* A history of significant head or neck trauma (as judged by the investigator) within the year prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01980927
Study Brief:
Protocol Section:
NCT01980927