Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction

Conditions

• High Tone Pelvic Floor Dysfunction

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Cyclobenzaprine — DRUG
  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 — DEVICE
  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 — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

Feb 18, 2026

Status verified

Feb 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Vilmarie Carmona
  269-760-7317
  [email protected]

Locations (1)

Find similar trials in Ann Arbor, MI

Related Studies

• Evaluation of Hyivy Floora in Managing Interstitial Cystitis/Bladder Pain Syndrome/High-tone Pelvic Floor Dysfunction
  Not Yet Recruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina