NCT07404397 · University of Michigan
Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Ann Arbor, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations