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临床试验/NCT00928564
NCT00928564已完成不适用

Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia: A Randomized Controlled Trial

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Visual Analog Pain Score After 6 Weekly Injections

研究概览

简要总结

Pelvic floor tension myalgia (PFTM) is increasingly noted in patients with chronic pelvic pain. Pelvic floor physical therapy is typically utilized and is at times combined with other therapies such as botox injections, trigger point injections or pudendal blocks. The investigators' study will randomize newly diagnosed patients with PFTM to weekly . Final patient assessment will be performed at 6 months to assess durability of response.

Primary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy will result in lower pain and pelvic floor muscle tension scores, lower baseline vaginal pressure and increase pelvic floor strength.

Secondary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy will result in a lower pain score in a shorter time frame, resulting in faster progress through physical therapy.

详细描述

Participants will be identified within UC Irvine urogynecology and/or pelvic floor physical therapy practice with the underlying diagnosis of pelvic floor tension myalgia. This diagnosis may be secondary to various underlying etiologies including interstitial cystitis/painful bladder syndrome, vulvodynia, endometriosis, adhesive disease, unknown etiology, etc. At the time of enrollment, participants will be randomized into one of two groups: either standard pelvic floor physical therapy with weekly saline placebo injections or standard pelvic floor physical therapy and weekly pudendal blocks for 6 weeks. Standard physical therapy techniques will be utilized in both groups. Weekly injections of a mixture of a steroid and local anesthetic or saline will be administered depending on the randomization. Injections will be administered by a urogynecology physician. The participant and the treating physical therapist will be blinded to treatment assignment. The participant will be evaluated with for pelvic floor muscle strength and tenderness and will have pain assessed by a visual analog scale at baseline, weekly throughout the study, and at 6 months after study enrollment. Vaginal electromyography will be performed and standardized questionnaires regarding pelvic floor symptoms, quality of life and sexual function will be administered at baseline, after 6 weeks of injections and at 6 months after enrollment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Non-pregnant women over the age of 18 with the diagnosis of pelvic floor tension myalgia that are naive to pelvic floor physical therapy.
  • Able to provide informed consent.
  • Subjects must be willing to accept randomization.

排除标准

  • Previously treated with physical therapy.
  • An allergy to any component within the pudendal block.
  • Bleeding disorders.
  • Active vaginal infection.
  • Inability to complete the questionnaires.
  • Inability to read English (validated questionnaires are available in English only).
  • Inability to complete the follow-up visits.

研究组 & 干预措施

Pudendal Block

Active Comparator

8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.

干预措施: Pudendal block (Drug)

Placebo

Placebo Comparator

5ml of saline at each block site

干预措施: Placebo (Drug)

结局指标

主要结局

Visual Analog Pain Score After 6 Weekly Injections

时间窗: up to 8 weeks

10 point likert scale to report pain a score from zero for no pain to ten for the worst possible pain

次要结局

  • Improvement in Pelvic Floor Symptoms as Assessed Through Validated Questionnaires(up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Felicia Lane

Associate Professor

University of California, Irvine

研究点 (1)

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