Health TrialsbyHealthPanel

Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction

ConditionHigh Tone Pelvic Floor Dysfunction
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity of Michigan

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cyclobenzaprine PFPTExperimental treatment 2 interventions
Group B: Pelvic floor massage wand & PFPTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score

PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference

Time frame
Baseline, 18 weeks
2

PROMIS pain interference 4a score

PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference

Time frame
Baseline, 6 weeks

Secondary outcomes

1

50% reduction in PROMIS pain interference 4a score

PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference

Time frame
18 weeks compared to baseline
2

PROMIS pain intensity 1a score

PROMIS pain intensity 1a score is 1 question ranging from 0-10 and the higher the number the worse the pain.

Time frame
Baseline, 18 weeks
3

PROMIS pain intensity 1a score

PROMIS pain intensity 1a score is 1 question ranging from 0-10 and the higher the number the worse the pain.

Time frame
Baseline, 6 weeks
4

Female Sexual Function Index (FSFI)

Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning.

Time frame
Baseline, 18 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

The American Association of Obstetricians and Gynecologists Foundation

Collaborator

Source ClinicalTrials.gov
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