Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome in Participants Who Have Not Responded to Physical Therapy Treatment: A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Effectiveness of rectal administration versus oral administration in LAS pain management: Visual Analog Scale (VAS)
研究概览
简要总结
This research involves collecting data about levator ani syndrome (LAS) associated rectal pain and a comparison of diazepam treatment administration routes. The goal of this research is to see if an alternative route of diazepam administration provides sufficient control of LAS discomfort and low sleep quality while minimizing systemic effects of diazepam (drowsiness).
详细描述
Levator ani syndrome (LAS) is described as a dull, aching pain of a patient's pelvic floor musculature. There is no known cause for the syndrome, yet pelvic floor muscle spasm and increased anal resting pressures have been hypothesized to result in the syndrome. LAS is commonly seen in patients with constipation, specifically outlet dysfunction constipation. Treatment for the syndrome involves a combination of bowel management, medications, and pelvic floor physical therapy (PT). Pelvic floor PT uses a variety of methods to help patients with LAS, including biofeedback and massage. The literature and the investigators experience shows that these pelvic floor PT approaches do not resolve all LAS symptoms.
Diazepam (Valium®) is used to treat levator ani syndrome in conjunction with other treatments to help relax the pelvic floor muscle group (levator ani). Diazepam has U.S. Food and Drug Administration (FDA) approval for use as a muscle relaxant. Investigators at Swedish Colon & Rectal Clinic are using diazepam intervention as a means for patients to gain relief from pain.
The work proposed aims to provide the first prospective, randomized, comparative study of the efficacy between administering diazepam rectally and administering the medication orally after pelvic floor PT treatment. Currently, other ways of administering diazepam have not been studied in the setting of the LAS condition. The Investigators performed a retrospective chart review last year and found some promising results for the efficacy of rectal and oral routes of diazepam for LAS. The Investigators want to determine if the route of administering diazepam as an adjunct to pelvic floor PT influences rectal pain relief for LAS patients.
Primary Objective: Compare the pain scores of participants with LAS after administering diazepam rectally or orally following six weeks of physical therapy.
Secondary Objectives:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of LAS according to the Rome IV criteria with:
- •Chronic or recurrent rectal pain or aching
- •Episodes lasting 30 minutes or longer
- •Tenderness during traction on the puborectalis
- •Exclusion of other causes of rectal pain
- •Patients who agree to undergo pelvic floor PT for six weeks prior to starting the medication treatment.
- •Women ≥ 18 years of age. Women of childbearing potential must undergo urine pregnancy testing prior to using the treatment medication.
- •Men ≥ 18 years of age.
排除标准
- •Participants who have had pelvic floor surgery or with recent conditions in which rectal suppositories are contraindicated.
- •Non-English speaking participants.
- •Women who are pregnant or breastfeeding.
- •Participants who are cognitively impaired, illiterate, or have a condition in which they are unable to consent for themselves.
- •Participants allergic to benzodiazepines or have a sensitivity/intolerance to benzodiazepines.
- •Participants to which benzodiazepines are contraindicated or are on medications that interact with benzodiazepines.
- •Participants with current or history of Diagnostic and Statistical Manual of Mental Disorders (DSM-V) substance use disorder or Participants with a history of evidence of severe illness or any other conditions that would affect absorption or make the patient unsuitable for the study in the opinion of the investigator.
- •Participants already receiving medications in the benzodiazepine class within 2 weeks of screening visit for any reasons will be excluded based on increased risk for medication tolerance.
- •Participants who have undergone pelvic floor PT within 2 weeks of screening visit.
研究组 & 干预措施
Oral Administration
10 mg diazepam tablets to be taken orally once daily for 4 weeks.
干预措施: Diazepam Tablets (Drug)
Rectal Administration
10 mg diazepam tablets to be taken rectally once daily for 4 weeks.
干预措施: Diazepam Tablets (Drug)
结局指标
主要结局
Effectiveness of rectal administration versus oral administration in LAS pain management: Visual Analog Scale (VAS)
时间窗: 10 weeks
Participants will complete weekly electronic Visual Analog Scale (VAS) for pain for 6 weeks while on Physical Therapy only, followed by 4 weeks while taking diazepam (orally or rectally). Participants will be asked to select a number on a scale of 1 to 10, where 1 equals no pain and 10 equals worst pain.
次要结局
- Study Medication Adherence(4 weeks)
- Participant drowsiness while taking diazepam rectally versus orally(10 weeks)
- Participant sleep quality while taking diazepam rectally versus orally: Pittsburg Sleep Quality Index(10 weeks)