Muscle relaxant versus vibrating pelvic massage wand plus pelvic floor therapy for high-tone pelvic floor dysfunction
Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction: a Pilot Randomized Controlled Trial
This trial will test whether taking a daily muscle relaxant (cyclobenzaprine) or using a vibrating pelvic floor massage wand, together with pelvic floor physical therapy, helps people with high-tone pelvic floor dysfunction reduce pain and improve function.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07404397 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 2/3 trial compares two adjuvant treatments given alongside a standardized 12-session pelvic floor physical therapy program for people with high-tone pelvic floor dysfunction. Participants are randomized to daily immediate-release cyclobenzaprine or regular use of a vibrating pelvic floor massage wand for an 18-week intervention period while completing pelvic floor physical therapy. Outcomes include measures of pelvic pain intensity, sexual health, physical ability, and overall quality of life. The trial is conducted at the University of Michigan and enrolls adults with moderate-to-severe chronic pelvic pain and documented high-tone pelvic floor tenderness.
Who should consider this trial
Good fit: Adults with documented high-tone pelvic floor dysfunction and moderate-to-severe chronic pelvic pain who have been referred for pelvic floor physical therapy and are willing to be randomized to medication or a vibrating wand and to delay starting therapy until study enrollment are ideal candidates.
Not a fit: People without high-tone pelvic floor dysfunction, with only mild pelvic pain, with contraindications to cyclobenzaprine, or unwilling to undergo internal pelvic therapy or travel to the study site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the superior adjuvant could reduce pelvic pain and improve sexual function, daily activities, and quality of life when added to pelvic floor physical therapy.
How similar studies have performed: Pelvic floor physical therapy has demonstrated benefit for pelvic pain, but direct comparisons of cyclobenzaprine versus vibrating pelvic massage wands as adjuvants are limited, making this a partially novel comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Sara Till, MD, MPH — University of Michigan
- Study coordinator: Vilmarie Carmona
- Email: vilmarie@umich.edu
- Phone: 269-760-7317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.