Cyclobenzaprine + Pelvic Floor Massage Wand for Pelvic Floor Hypertonicity

Overseen By Vilmarie Carmona

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: University of Michigan

Must not be taking: Muscle relaxants, Tricyclics, MAOIs, Benzodiazepines

Disqualifiers: Pregnancy, Breastfeeding, Neurologic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Sara Till, MD, MPH

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with chronic pelvic pain and diagnosed high tone pelvic floor dysfunction, who have been referred to undergo a specific type of physical therapy. Participants must have experienced moderate to severe pain for over six months and be willing to try either a muscle relaxant or a massage wand alongside their therapy.

Inclusion Criteria

I have been diagnosed with high tone pelvic floor dysfunction in the last year.

I've been referred for pelvic floor physical therapy for my chronic pelvic pain.

I am willing to undergo 12 sessions of pelvic floor physical therapy that includes internal procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants use either cyclobenzaprine or a pelvic floor massage wand

6 weeks

Regular visits for monitoring

Phase 2 Treatment

Participants continue their initial treatment and complete a course of pelvic floor physical therapy

12 weeks

Regular visits for therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cyclobenzaprine
• Pelvic floor massage wand

Trial Overview

The study aims to compare the effectiveness of cyclobenzaprine (a muscle relaxant) versus a vibrating massage wand when used in conjunction with regular pelvic floor physical therapy. The impact on pain, sexual health, physical function, and quality of life will be evaluated.

How Is the Trial Designed?

Group I: Pelvic floor massage wand & PFPT Experimental Treatment 2 Interventions

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.

Group II: Cyclobenzaprine PFPT Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

The American Association of Obstetricians and Gynecologists Foundation

Collaborator