Recruiting
Phase 2
Phase 3

Cyclobenzaprine vs. Wand

Sponsor:

University of Michigan

Code:

NCT07404397

Conditions

High Tone Pelvic Floor Dysfunction

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cyclobenzaprine

Pelvic floor massage wand

Pelvic floor physical therapy

Study Details

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

Study ID

NCT07404397

Start date

Feb 18, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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).

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.

Primary outcome measure

  • Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score [ Time Frame: Baseline, 18 weeks ]
  • PROMIS pain interference 4a score [ Time Frame: Baseline, 6 weeks ]

Central Contacts and Locations

Central contacts

Vilmarie Carmona

269-760-7317vilmarie@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Vilmarie Carmona

269-760-7317vilmarie@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-02-20.