The Role of a Postoperative Home Physical Therapy Program for the Treatment of Pelvic Pain in Patients Undergoing Endometriosis Excision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Short Form Survey (SF-36)
研究概览
简要总结
This is a randomized controlled pilot study comparing a home pelvic floor physical therapy program to routine post-operative care for patients undergoing endometriosis excisional surgery without hysterectomy. Quality of life and endometriosis symptoms will be compared following the recovery period.
详细描述
This is a randomized controlled pilot study conducted at a single institution comparing a home pelvic floor physical therapy program to routine post-operative care for patients undergoing endometriosis excisional surgery without hysterectomy. Patients will be recruited from a referral gynecological surgery group specializing in the diagnosis and treatment of pelvic pain and endometriosis. The goal is to assess the role of the active recovery program on quality of life and on pain and endometriosis symptoms.
Subjects will be randomized to routine post-operative care or to a home physical therapy program, in which they will receive written instruct ions and videos of exercises to complete immediately after surgery. The home exercise program was developed by the Department of Urogynecology in conjunction with pelvic floor physical therapists, and includes videos created by the education communications division. Quality of life, pain score, and endometriosis symptoms will be assessed at their pre-operative appointment, and at 6 and 12 weeks postoperatively.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal
- •English speaking
- •Undergoing endometriosis excision surgery without hysterectomy at Legacy Health with subspecialty-trained surgeons specializing in endometriosis care
- •History of chronic pelvic pain (defined as >= 6 months of pain in the anatomic pelvis)
- •Diagnosis of high tone pelvic floor dysfunction on examiniation
- •Have access to reliable email and phone for study-related communication
排除标准
- •Non-English speaking
- •Unable to consent
- •Unable to sustain 30 minutes of moderate activity at baseline
- •Uses a mobility assistive device at baseline
- •Chronic opioid use
- •No histologic diagnosis of endometriosis on surgical pathology
- •Need for additional pelvic rest (>2 weeks) postoperatively
- •Pregnancy or planning to pursue pregnancy or undergo fertility treatments within 12 weeks postoperatively
研究组 & 干预措施
Active Recovery
Participants will receive postoperative instructions to follow an active recovery protocol focused on increasing activity level, core strength exercises, and pelvic floor exercises focused on urinary and bowel symptoms. Exercises are to be completed twice per day for the 12 weeks following surgery.
干预措施: Active Recovery (Behavioral)
Standard Postoperative Instructions
Participants will receive standard postoperative recovery instructions
干预措施: Standard Postoperative Instructions (Behavioral)
结局指标
主要结局
Short Form Survey (SF-36)
时间窗: Collected immediately following surgery, 6 weeks following surgery, and 12 weeks following surgery
The Short Form Survey (SF-36) is a 36-item survey regarding general health and pain and its impact on quality of life including physical activities, work, social activities, and emotional well-being over the last four weeks. Scores range from 0 to 100 with a higher score representing a more favorable health state.
Pelvic Floor Impact Questionnaire (PFIQ)
时间窗: Collected immediately following surgery and 12 weeks following surgery
The Pelvic Floor Impact Questionnaire (PFIQ) asks about how bladder, bowel, and pelvic symptoms affect the ability to do physical activities as well as their impact on emotional well-being over the last 3 months. Scores range from 0 to 300 with a lower score representing a lesser impact on quality of life.
次要结局
- Pain Scores(Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.)
- Endometriosis Health Profile (EHP-5)(Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.)
研究者
Jacqueline Wong
Principal Investigator
Oregon Health and Science University