A Novel Therapeutic Approach to Treat Chronic Pelvic Pain (NCT05467241) | Clinical Trial Compass
CompletedNot Applicable
A Novel Therapeutic Approach to Treat Chronic Pelvic Pain
United States10 participantsStarted 2021-08-12
Plain-language summary
To collect pilot data and assess the feasibility of a trial employing a single-arm intervention to study the effects of combined self-induced therapeutic tremors plus mindfulness on symptoms of chronic pelvic pain among women diagnosed with chronic pelvic pain.
Who can participate
Age range
18 Years – 80 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:
* Women
* Age \>18
* Physical requirements: be able to complete the intervention sessions
* Not seeking other therapeutic modalities, such as acupuncture, PT, during study duration
* Free from surgery for \>3 months
* being treated clinically for chronic pelvic pain and related conditions
* CPP of 6 months or more (to be considered chronic)
* Availability to commit to the 4-week intervention (two 60-minute sessions per week at a specified time, for 4 weeks)
* Internet access and consistent access to phone/email/text communication
Exclusion Criteria:
* Pregnancy
* Illicit substance use (e.g. cocaine, methamphetamines, heroin, street drugs) - marijuana and CBD oil and related supplements will be considered on a case-by-case basis by the principal investigators
* Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators
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
Feasibility of the pilot trial
Timeframe: This will be assessed at the completion of the study, approximately 1-1.5 years after the study start.
Trial details
NCT IDNCT05467241
SponsorUniversity of Tennessee Graduate School of Medicine