Cyclobenzaprine + Pelvic Floor Massage Wand for Pelvic Floor Hypertonicity

VC
Overseen ByVilmarie Carmona
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two additional treatments for individuals with high tone pelvic floor dysfunction (HTPFD), a condition that causes chronic pelvic pain. Researchers aim to determine whether a muscle relaxant (cyclobenzaprine) or a vibrating massage wand is more effective when combined with pelvic floor physical therapy. Participants will already engage in regular pelvic floor therapy and must be willing to try one of the two treatments for 18 weeks. Ideal candidates have experienced moderate to severe pelvic pain for at least six months and are open to following the study's treatment plan. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in managing pelvic pain.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to participate in this trial. If you are currently using cyclobenzaprine, other muscle relaxants, tricyclic antidepressants, monoamine oxidase inhibitors, or vaginally delivered benzodiazepines, you will need to stop using them for the duration of the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cyclobenzaprine often helps with muscle pain, including pelvic floor issues. Studies have found that most people tolerate it well. Some might experience drowsiness or dry mouth, but serious side effects are rare.

Research indicates that the pelvic floor massage wand is safe when used properly. It can relieve pain and muscle tightness in the pelvic area. Proper training is necessary to avoid discomfort or minor irritation.

Both treatments have been studied for safety and are generally considered safe with few serious side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for pelvic floor hypertonicity because they offer novel approaches beyond the traditional physical therapy and muscle relaxants typically used. Cyclobenzaprine, a muscle relaxant, is being tested in combination with pelvic floor physical therapy, potentially enhancing its effectiveness by directly targeting muscle stiffness. Meanwhile, the use of a pelvic floor massage wand offers a new, hands-on approach that allows individuals to actively participate in their treatment, potentially improving muscle relaxation and reducing discomfort. These innovative methods could provide more personalized and effective options for managing pelvic floor hypertonicity.

What evidence suggests that this trial's treatments could be effective for pelvic floor hypertonicity?

Research shows that cyclobenzaprine, a muscle relaxant, can reduce muscle tightness and spasms common in high tone pelvic floor dysfunction (HTPFD). This may relieve pain and improve quality of life for those with the condition. In this trial, some participants will use cyclobenzaprine alongside pelvic floor physical therapy. Studies also indicate that a pelvic floor massage wand can directly massage tight muscles, reducing tension and pain in the pelvic area. Other participants in this trial will use the pelvic floor massage wand with pelvic floor physical therapy. Both treatments aim to improve comfort and daily activities for those with HTPFD. Early evidence suggests that combining these treatments with pelvic floor physical therapy might enhance their effectiveness.16789

Who Is on the Research Team?

ST

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.
See 7 more

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?

2

Treatment groups

Experimental Treatment

Group I: Pelvic floor massage wand & PFPTExperimental Treatment2 Interventions
Group II: Cyclobenzaprine PFPTExperimental Treatment2 Interventions

Find a Clinic Near You

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

Citations

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A Treatment Algorithm for High-Tone Pelvic Floor Dysfunction

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Cyclobenzaprine + Pelvic Floor Massage Wand for ...

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Chronic Pelvic Pain

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1 A Clinical Consensus Treatment Algorithm for Patients ...

A clinical care pathway for high-tone pelvic floor dysfunction will enable more effective care of. 56 patients and empower future studies to ...

Skeletal Muscle Relaxants for the Treatment of Myofascial ...

... Pelvic Pain and High Tone Pelvic Floor Disorders ... muscle relaxants for chronic pelvic pain secondary to myofascial and hypertonic muscular dysfunction.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37387696/

Skeletal muscle relaxants for the treatment of myofascial ...

The treatment of myofascial pelvic pain and high tone pelvic floor disorders can be managed with skeletal muscle relaxants for select clinical indications.

Skeletal muscle relaxants for the treatment of myofascial ...

... pelvic floor hypertonic disorder. View. Show ... Vaginal Diazepam Use with Urogenital Pain/Pelvic Floor Dysfunction: Serum Diazepam Levels and Efficacy Data.

Efficacy and safety of pelvic floor magnetic stimulation ... - PMC

As everyone knows, overactive bladder (OAB), defined by the International Association for Urology, was a syndrome characterized by urgency of ...