Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction

Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction: a Pilot Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: High Tone Pelvic Floor Dysfunction
• Intervention / Treatment: Drug: Cyclobenzaprine; Procedure: Pelvic floor physical therapy; Device: Pelvic floor massage wand

Detailed Description

Devices such as the Intimate Rose Vibrating Pelvic Floor Massage Wand are not required to indicate a phase for ClinicalTrials.gov. However, this study is marked as phase 2/3 considering the use of a study drug, Cyclobenzaprine.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Vilmarie Carmona; Phone Number: 269-760-7317; Email: vilmarie@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Vilmarie Carmona; Phone Number: 269-760-7317; Email: vilmarie@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cyclobenzaprine PFPT; 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; 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.; Other Names: Flexeril; Procedure: Pelvic floor physical therapy; 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.
Experimental: Pelvic floor massage wand & PFPT; 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.	Procedure: Pelvic floor physical therapy; 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.; Device: Pelvic floor massage wand; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
50% reduction in 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	18 weeks compared to baseline
PROMIS pain intensity 1a score	PROMIS pain intensity 1a score is 1 question ranging from 0-10 and the higher the number the worse the pain.	Baseline, 18 weeks
PROMIS pain intensity 1a score	PROMIS pain intensity 1a score is 1 question ranging from 0-10 and the higher the number the worse the pain.	Baseline, 6 weeks
Female Sexual Function Index (FSFI)	Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning.	Baseline, 18 weeks
Female Sexual Function Index (FSFI)	Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning.	Baseline, 6 weeks
PROMIS Self Efficacy for Managing Symptoms SF 4a	PROMIS Self Efficacy for Managing Symptoms SF 4a is 4 questions with scores ranging from 4-20. Highter scores indicate higher confidence in symptom management	Baseline, 18 weeks
PROMIS Self Efficacy for Managing Symptoms SF 4a	PROMIS Self Efficacy for Managing Symptoms SF 4a is 4 questions with scores ranging from 4-20. Highter scores indicate higher confidence in symptom management	Baseline, 6 weeks
Summative pelvic floor myofascial tenderness to palpation	For Bilateral pubococcygeus, Bilateral iliococcygeus, and Bilateral obturator internus	Baseline, 18 weeks
Summative pelvic floor myofascial tenderness to palpation	For Bilateral pubococcygeus, Bilateral iliococcygeus, and Bilateral obturator internus	Baseline, 6 weeks
Patient Global Impression of Change	The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.	18 weeks
Patient Global Impression of Change	The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.	6 weeks
Number of pelvic floor physical therapy (PFPT) sessions attended	PFPT session attendance will be tracked by patient self-report	Up to 18 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: The American Association of Obstetricians and Gynecologists Foundation
• Investigators: Principal Investigator: Sara Till, MD, MPH, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cyclobenzaprine; pelvic floor physical therapy; vibrating pelvic floor massage wand
• Additional Relevant MeSH Terms: cyclobenzaprine
• Other Study ID Numbers: HUM00280388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final de-identified, anonymized data sets underlying all publications resulting from the proposed research involving human subjects will be shared with legitimate academic researchers and other community members with a legitimate scientific interest in the research. Where practicable, sharing will take place under a written agreement between the principal investigators prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the datasets. The aim is to permit others to validate and replicate research findings described in the Aims while protecting participant confidentiality.
• IPD Sharing Time Frame: The research community will have access to the data when the award ends.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No