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Recruiting NCT07404397

Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction

Phase II / Phase III Interventional High Tone Pelvic Floor Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cyclobenzaprine, Pelvic floor massage wand, Pelvic floor physical therapy.
Who it may be relevant to
Registry conditions: High Tone Pelvic Floor Dysfunction. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction: a Pilot Randomized Controlled Trial

Overview

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.

Detailed description

Devices such as the Intimate Rose Vibrating Pelvic Floor Massage Wand are not required to indicate a phase for ClinicalTrials.gov. However, this study is marked as phase 2/3 considering the use of a study drug, Cyclobenzaprine.

Interventions

  • Drug Cyclobenzaprine
    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.
  • Device Pelvic floor massage wand
    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).
  • Procedure Pelvic floor physical therapy
    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.

Primary outcome measures

  • Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score [Time frame: Baseline, 18 weeks]
  • PROMIS pain interference 4a score [Time frame: Baseline, 6 weeks]
Secondary outcome measures (12)
  • 50% reduction in PROMIS pain interference 4a score [Time frame: 18 weeks compared to baseline]
  • PROMIS pain intensity 1a score [Time frame: Baseline, 18 weeks]
  • PROMIS pain intensity 1a score [Time frame: Baseline, 6 weeks]
  • Female Sexual Function Index (FSFI) [Time frame: Baseline, 18 weeks]
  • Female Sexual Function Index (FSFI) [Time frame: Baseline, 6 weeks]
  • PROMIS Self Efficacy for Managing Symptoms SF 4a [Time frame: Baseline, 18 weeks]
  • PROMIS Self Efficacy for Managing Symptoms SF 4a [Time frame: Baseline, 6 weeks]
  • Summative pelvic floor myofascial tenderness to palpation [Time frame: Baseline, 18 weeks]
  • Summative pelvic floor myofascial tenderness to palpation [Time frame: Baseline, 6 weeks]
  • Patient Global Impression of Change [Time frame: 18 weeks]
  • Patient Global Impression of Change [Time frame: 6 weeks]
  • Number of pelvic floor physical therapy (PFPT) sessions attended [Time frame: Up to 18 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT07404397 · HUM00280388

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗