Pelvic pain study tests muscle relaxant vs. vibrating wand
NCT ID NCT07404397
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two additional treatments for high tone pelvic floor dysfunction (HTPFD) when combined with standard pelvic floor physical therapy. Participants will either take a muscle relaxant medication (cyclobenzaprine) or use a vibrating pelvic floor massage wand. The goal is to see which option better reduces pain, improves sexual health, and enhances quality of life. The study involves 60 adults with chronic pelvic pain lasting more than 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Self-reported moderate to severe chronic pelvic pain for \>6 months duration at time of screening visit. Moderate to severe chronic pain is defined as \>4 on 0-10 (worst daily pain) for \>14 days per month. Pelvic pain is defined as pain perceived to be located in the anatomic pelvis. * Diagnosis of high tone pelvic floor dysfunction (HTPFD), defined as \>12/60 summative pelvic floor tenderness score on standardized pelvic examination by chronic pelvic pain specialist (MD or NP) within the past year * Referred to pelvic floor physical therapy (PFPT) by their chronic pelvic pain specialist for management of HTPFD * Willing to undergo a 12-session course of PFPT for HTPFD, including internal/vaginal tissue manipulation per standardized protocol * Willing to delay start of PFPT until Phase 2 of the trial * Willing to be randomized to either daily use of cyclobenzaprine or use of vibrating pelvic floor muscle massage wand for total of 18 weeks * Willing to undergo standardized pelvic floor myofascial exam three times over the study period (baseline, end of Phase 1, end of Phase 2) * Willing to undergo quantitative sensory testing (QST) two times over the study period (baseline, end of Phase 1) * Willing to undergo blood draw two times over the study period (baseline, end of Phase 1) * Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcome measures * No plans for pregnancy within the next 12 months Exclusion Criteria: * Hypersensitivity or allergy to cyclobenzaprine or any component of cyclobenzaprine * Underwent PFPT within 6 months of screening date * Pregnancy at any point during study period (self-reported home urine pregnancy test or serum b-Hcg test, positive urine pregnancy test at baseline, post-Phase 1, or post-Phase 2 study visits). * Currently breastfeeding at time of screening visit * Scheduled for or are planning moderate/major gynecologic surgery (including hysterectomy, excision of endometriosis, ovarian cystectomy/oopherectomy, myomectomy) within the following 6 months of screening date * Current (at time of screening visit) diagnosis of postural orthostatic tachycardia syndrome * Current significant neurologic or musculoskeletal conditions that would preclude participation in PFPT (cerebral palsy, severe hip/back osteoarthritis that would prevent lithotomy position during sessions) * Unwilling to avoid or stop baseline use of cyclobenzaprine and other muscle relaxants (including methocarbamol, tizanidine, baclofen, carisoprodol, metaxalone) * Current use of tricyclic antidepressants * Current use of monoamine oxidase inhibitor * Current use of vaginally delivered benzodiazepine such as diazepam (more than once per month) and unwilling to stop use of vaginally delivered benzodiazepine for the duration of this study * Current diagnosis of hyperthyroidism * Current diagnosis of moderate or severe hepatic impairment * Myocardial infarction within prior 12 months * Current diagnosis of congestive heart failure * Current cardiac pacemaker in place * Current diagnosis of closed angle glaucoma * Current major psychiatric condition (including psychosis or suicidal ideation within past year)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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