Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction
ConditionHigh Tone Pelvic Floor Dysfunction
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cyclobenzaprine
- Pelvic floor massage wand
- Pelvic floor physical therapy
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Michigan
Lead sponsor
The American Association of Obstetricians and Gynecologists Foundation
Collaborator
Source ClinicalTrials.gov