Actively Recruiting
Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction
Led by University of Michigan · Updated on 2026-02-20
60
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
T
The American Association of Obstetricians and Gynecologists Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The researchers are comparing two treatments for high tone pelvic floor dysfunction (HTPFD) in conjunction with pelvic floor physical therapy (PFPT). The goal of this study is to find out which of two extra treatments works better for people with HTPFD when they also do regular PFPT. First, the researchers will compare a muscle relaxant medicine (cyclobenzaprine IR) to using a vibrating pelvic floor massage wand. Everyone in the study will also do pelvic floor physical therapy. The researchers want to see how these treatments affect pain, sexual health, physical ability, and overall quality of life.
CONDITIONS
Official Title
Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-reported moderate to severe chronic pelvic pain for more than 6 months, with pain greater than 4 on a 0-10 scale for more than 14 days per month
- Diagnosis of high tone pelvic floor dysfunction with a pelvic floor tenderness score greater than 12 out of 60 on exam within the past year
- Referred to pelvic floor physical therapy by a chronic pelvic pain specialist for HTPFD management
- Willing to undergo a 12-session course of pelvic floor physical therapy including internal/vaginal manipulation
- Willing to delay the start of pelvic floor physical therapy until Phase 2 of the trial
- Willing to be randomized to daily cyclobenzaprine or use of vibrating pelvic floor muscle massage wand for 18 weeks
- Willing to have standardized pelvic floor exams three times during the study
- Willing to undergo quantitative sensory testing twice during the study
- Willing to have blood draws twice during the study
- Able to read and speak English to give informed consent and complete questionnaires
- No plans for pregnancy within the next 12 months
You will not qualify if you...
- Allergy or hypersensitivity to cyclobenzaprine or its components
- Underwent pelvic floor physical therapy within 6 months before screening
- Pregnancy during any study period
- Currently breastfeeding at screening
- Planned moderate or major gynecologic surgery within 6 months after screening
- Current diagnosis of postural orthostatic tachycardia syndrome
- Significant neurologic or musculoskeletal conditions preventing participation in pelvic floor physical therapy
- Unwilling to avoid or stop use of cyclobenzaprine or other muscle relaxants during the study
- Current use of tricyclic antidepressants or monoamine oxidase inhibitors
- Current use of vaginal benzodiazepines more than once per month and unwilling to stop during the study
- Current diagnosis of hyperthyroidism
- Moderate or severe liver impairment
- Heart attack within previous 12 months
- Current congestive heart failure
- Having a cardiac pacemaker
- Current closed angle glaucoma
- Major psychiatric condition including recent psychosis or suicidal thoughts
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
V
Vilmarie Carmona
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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