Effect of Spinal Manipulation on Vulvar Pain (NCT04016467) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Spinal Manipulation on Vulvar Pain
Stopped: Lack of participants in available recruitment area
United States2 participantsStarted 2019-05-10
Plain-language summary
The purpose of the study is to determine the effect of thoracic spine manipulation on vestibule pain as determined by sensory testing (q-tip and pressure algometry) in a group of women with provoked vestibulodynia (PVD). The objective is to compare the immediate effect of manipulation and sham manipulation on the results of sensory testing of the external vulva, or vestibule.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 medication…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Numeric Pain Rating Scale (NPRS) (0=none to 10=worst) report to cotton swab test in clock pattern
Timeframe: Pre and immediately post thoracic intervention. No longer term follow-up is planned.