Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction

NCT07404397 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: HUM00280388
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

High Tone Pelvic Floor Dysfunction

Keywords

pelvic floor physical therapy; cyclobenzaprine; vibrating pelvic floor massage wand

Outcome Measures

Primary Outcomes (2)

• Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score

  PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference

  Baseline, 18 weeks

• PROMIS pain interference 4a score

  PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference

  Baseline, 6 weeks

Secondary Outcomes (12)

• 50% reduction in PROMIS pain interference 4a score

  18 weeks compared to baseline

• PROMIS pain intensity 1a score

  Baseline, 18 weeks

• PROMIS pain intensity 1a score

  Baseline, 6 weeks

• Female Sexual Function Index (FSFI)

  Baseline, 18 weeks

• Female Sexual Function Index (FSFI)

  Baseline, 6 weeks

Study Arms (2)

Cyclobenzaprine PFPT

EXPERIMENTAL

During Phase 1, participants will be instructed to use cyclobenzaprine as detailed below. During Phase 2, participants will complete a course of pelvic floor physical therapy and will continue using cyclobenzaprine.

Drug: Cyclobenzaprine; Procedure: Pelvic floor physical therapy

Pelvic floor massage wand & PFPT

EXPERIMENTAL

During Phase 1, participants will be instructed to use pelvic floor massage wand as detailed below. During Phase 2, participants will complete a course of pelvic floor physical therapy and will continue using pelvic floor massage wand.

Device: Pelvic floor massage wand; Procedure: Pelvic floor physical therapy

Interventions

Cyclobenzaprine DRUG

Participants will be instructed to use cyclobenzaprine IR 5mg at bedtime. We will encourage participants to take the medication in the evening/before bed to minimize potential for bothersome sedation. Participants will be given the option to begin with ½ tablet (2.5mg) if preferred and titrate to 5mg dose, with goal of minimizing sedation side effects. Participants will be instructed that they may increase to 10mg at bedtime at Day 14 if desired based on perceived benefits and side effects.

Also known as: Flexeril

Cyclobenzaprine PFPT

Pelvic floor massage wand DEVICE

Participants will be instructed to use a commercially available vibrating pelvic floor massage wand for approximately 10-15 minutes at least 3 times per week, which can be titrated as needed (standard use recommendations per our pelvic physical therapists).

Pelvic floor massage wand & PFPT

Pelvic floor physical therapy PROCEDURE

Pelvic floor physical therapy for HTPFD uses manual manipulation to release localized muscle tension or trigger points, improve mobility of fascia, and address orthopaedic issues such as pelvic alignment and spine/hip mobility to reduce pain and improve function.

Cyclobenzaprine PFPT; Pelvic floor massage wand & PFPT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• The American Association of Obstetricians and Gynecologists Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Interventions

cyclobenzaprine

Study Officials

• Sara Till, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vilmarie Carmona

CONTACT

269-760-7317; vilmarie@umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology, Medical School

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 11, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: The research community will have access to the data when the award ends.
• Access Criteria: academic researchers and other community members with a legitimate scientific interest in the research. Members of the scientific community who would like a curated copy of the final datasets (i.e., datasets underlying publications) from this study can request a copy by contacting the principal investigators.

Locations

US (1)