Ann Arbor, MINCT07404397Now EnrollingIRB Ready

High Tone Pelvic Floor Dysfunction Clinical Trial in Ann Arbor, MI

Access cutting-edge high tone pelvic floor dysfunction treatment through this clinical trial at a research site in Ann Arbor. Study-provided care at no cost to qualified participants.

Sponsored by University of Michigan

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Expert Care in Ann Arbor

Access high tone pelvic floor dysfunction specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related high tone pelvic floor dysfunction treatment provided free

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Check if you qualify for this high tone pelvic floor dysfunction clinical trial in Ann Arbor, MI

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Ann Arbor

    Convenient for MI residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Ann Arbor site if eligible
  4. 4Begin participation

About This High Tone Pelvic Floor Dysfunction Study in Ann Arbor

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.

Sponsor: University of Michigan

Who Can Participate

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT07404397) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

High Tone Pelvic Floor Dysfunction Treatment Options in Ann Arbor, MI

If you're searching for high tone pelvic floor dysfunction treatment options in Ann Arbor, MI, this clinical trial (NCT07404397) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this clinical trial. You'll receive care from experienced high tone pelvic floor dysfunction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all high tone pelvic floor dysfunction clinical trials near you to find additional studies recruiting in your area.

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