High Tone Pelvic Floor Dysfunction
Conditions
Keywords
pelvic floor physical therapy, cyclobenzaprine, vibrating pelvic floor massage wand
Brief summary
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
DRUGCyclobenzaprine
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.
DEVICEPelvic 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).
PROCEDUREPelvic 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.
Sponsors
University of Michigan
The American Association of Obstetricians and Gynecologists Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS pain interference 4a score | Baseline, 6 weeks | PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference |
| Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score | Baseline, 18 weeks | PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 50% reduction in PROMIS pain interference 4a score | 18 weeks compared to baseline | PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference |
| PROMIS Self Efficacy for Managing Symptoms SF 4a | Baseline, 18 weeks | 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 |
| Summative pelvic floor myofascial tenderness to palpation | Baseline, 18 weeks | For Bilateral pubococcygeus, Bilateral iliococcygeus, and Bilateral obturator internus |
| Patient Global Impression of Change | 18 weeks | 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. |
| PROMIS pain intensity 1a score | Baseline, 18 weeks | PROMIS pain intensity 1a score is 1 question ranging from 0-10 and the higher the number the worse the pain. |
| Number of pelvic floor physical therapy (PFPT) sessions attended | Up to 18 weeks | PFPT session attendance will be tracked by patient self-report |
| Female Sexual Function Index (FSFI) | Baseline, 18 weeks | Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning. |
Countries
United States
Contacts
CONTACTVilmarie Carmona
PRINCIPAL_INVESTIGATORSara Till, MD, MPH
University of Michigan
Outcome results
None listed