Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Устройство 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).
• Процедура 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.

Первичные конечные точки

• Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score [Срок оценки: Baseline, 18 weeks]
• PROMIS pain interference 4a score [Срок оценки: Baseline, 6 weeks]

Вторичные конечные точки (12)

• 50% reduction in PROMIS pain interference 4a score [Срок оценки: 18 weeks compared to baseline]
• PROMIS pain intensity 1a score [Срок оценки: Baseline, 18 weeks]
• PROMIS pain intensity 1a score [Срок оценки: Baseline, 6 weeks]
• Female Sexual Function Index (FSFI) [Срок оценки: Baseline, 18 weeks]
• Female Sexual Function Index (FSFI) [Срок оценки: Baseline, 6 weeks]
• PROMIS Self Efficacy for Managing Symptoms SF 4a [Срок оценки: Baseline, 18 weeks]
• PROMIS Self Efficacy for Managing Symptoms SF 4a [Срок оценки: Baseline, 6 weeks]
• Summative pelvic floor myofascial tenderness to palpation [Срок оценки: Baseline, 18 weeks]
• Summative pelvic floor myofascial tenderness to palpation [Срок оценки: Baseline, 6 weeks]
• Patient Global Impression of Change [Срок оценки: 18 weeks]
• Patient Global Impression of Change [Срок оценки: 6 weeks]
• Number of pelvic floor physical therapy (PFPT) sessions attended [Срок оценки: Up to 18 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07404397 · HUM00280388

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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