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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT04016467
Eligibility Criteria:
Inclusion Criteria:
* Provides written and dated informed consent to participate in the study.
* Is between the ages of 18-40 years.
* Reports pain in the pelvis and/or vestibule (area that is wiped after using the toilet) that has been present for ≥ 6 weeks.
* Has not had treatment for pelvic or vestibule pain in the 6 months prior to study participation.
* Is willing and able to comply with study protocol.
* Is healthy and free from disease, as determined by a health history questionnaire and screening exam.
* Agrees to abstain from alcohol consumption 24 hours prior to the study protocol.
* Reports a consistent regimen of pain medication use in the 6 weeks prior to the study protocol. This includes both prescription and over the counter medications.
* Secondary Inclusion Criteria: demonstrates provoked vestibule pain to q-tip testing.
Exclusion Criteria:
* Is currently pregnant, or attempting to become pregnant, as the intervention is contraindicated for this population.
* Fails the health history, spine screen; or does not demonstrate provoked vestibule pain with q-tip test.
* Has undergone any spine or pelvic girdle surgery in the 12 months prior to the study.
* Has ever had sling/mesh placement to the pelvic region.
* Has been diagnosed with osteopenia, osteoporosis, acute infection or arthritis flare, or other condition that could weaken the bony skeleton.
* Has ever had a thoracic spine fracture.
* Has had a change in any prescription or over-the-counter medications used for pain in the 6 weeks prior to the study.
* Any other condition or adverse event in which study investigator recommend removal from the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04016467
Study Brief:
Protocol Section:
NCT04016467