Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections
试验速览
- 阶段
- 4 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale
研究概览
简要总结
The purpose of this study is to evaluate which treatment option for pelvic floor pain allows for improved sexual function.
详细描述
Pelvic floor pain may be treated with trigger point injections with medications (steroids and local anesthetics) that are FDA approved for injection into muscles. The alternative is a noninvasive treatment option using pelvic rehabilitation which involves vaginal muscle massage. Both treatment options have been used and reported; however, rapidity of improvement and return to normal sexual function have not been assessed. This study assigns patients to either treatment option randomly and the sexual function is assessed based on standardized sexual function questionnaires as well as pain ratings.
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
- Single (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
- 否
入选标准
- •pelvic pain
- •pelvic floor myalgia
- •dyspareunia
- •age > 18 years
排除标准
- •interstitial cystitis
- •vaginal lesions / ulcerations
- •prior trigger point injections in the past 6 months
- •prior pelvic rehabilitation in the past 6 months
- •laparoscopically documented endometriosis / pelvic adhesions or adhesive disease
- •documented pelvic inflammatory disease identified within the past 6 months
- •documented sexually transmitted disease within the past 6 months
研究组 & 干预措施
Pelvic Rehabilitation
Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks
干预措施: Pelvic Rehabilitation (Procedure)
Trigger Point Injections
Trigger point injections will be administered on weekly basis for a total of 6 weeks
干预措施: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale
时间窗: Baseline, Week 10
Patients will be asked to rate their current pain prior to initiation of the treatment at the visits, at the start of the study and after the completion of the study, using the 10 point Iowa Pain scale.
次要结局
- Change in sexual function between visit 1 and visit 10(Baseline, Week 10)
研究者
Mary South
MD, Director of Female Pelvic Medicine & Reconstructive Surgery
University of Cincinnati