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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
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 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.
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGPatient-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
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
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
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
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
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
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, 6 weeks
PROMIS Self Efficacy for Managing Symptoms SF 4a
PROMIS Self Efficacy for Managing Symptoms SF 4a is 4 questions with scores ranging from 4-20. Highter scores indicate higher confidence in symptom management
Time frame: Baseline, 18 weeks
PROMIS Self Efficacy for Managing Symptoms SF 4a
PROMIS Self Efficacy for Managing Symptoms SF 4a is 4 questions with scores ranging from 4-20. Highter scores indicate higher confidence in symptom management
Time frame: Baseline, 6 weeks
Summative pelvic floor myofascial tenderness to palpation
For Bilateral pubococcygeus, Bilateral iliococcygeus, and Bilateral obturator internus
Time frame: Baseline, 18 weeks
Summative pelvic floor myofascial tenderness to palpation
For Bilateral pubococcygeus, Bilateral iliococcygeus, and Bilateral obturator internus
Time frame: Baseline, 6 weeks
Patient Global Impression of Change
The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.
Time frame: 18 weeks
Patient Global Impression of Change
The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.
Time frame: 6 weeks
Number of pelvic floor physical therapy (PFPT) sessions attended
PFPT session attendance will be tracked by patient self-report
Time frame: Up to 18 weeks
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