Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Cyclobenzaprine (Drug)
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.
干预措施: Pelvic floor physical therapy (Procedure)
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.
干预措施: Pelvic floor massage wand (Device)
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.
干预措施: Pelvic floor physical therapy (Procedure)
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score
时间窗: Baseline, 18 weeks
PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference
PROMIS pain interference 4a score
时间窗: Baseline, 6 weeks
PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference
次要结局
- 50% reduction in PROMIS pain interference 4a score(18 weeks compared to baseline)
- PROMIS pain intensity 1a score(Baseline, 18 weeks)
- PROMIS pain intensity 1a score(Baseline, 6 weeks)
- Female Sexual Function Index (FSFI)(Baseline, 18 weeks)
- Female Sexual Function Index (FSFI)(Baseline, 6 weeks)
- PROMIS Self Efficacy for Managing Symptoms SF 4a(Baseline, 18 weeks)
- PROMIS Self Efficacy for Managing Symptoms SF 4a(Baseline, 6 weeks)
- Summative pelvic floor myofascial tenderness to palpation(Baseline, 18 weeks)
- Summative pelvic floor myofascial tenderness to palpation(Baseline, 6 weeks)
- Patient Global Impression of Change(18 weeks)
- Patient Global Impression of Change(6 weeks)
- Number of pelvic floor physical therapy (PFPT) sessions attended(Up to 18 weeks)
研究者
Sara Till, MD, MPH
Assistant Professor of Obstetrics and Gynecology, Medical School
University of Michigan