Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain
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
- Change in Average Daily VAS Pain Score
研究概览
简要总结
The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.
详细描述
The investigators propose to conduct a clinical study to evaluate the effectiveness of TENS units on the management of endometriosis flare-related pain. Subjects will participate in a 3-month "baseline" period (no TENS unit use for endometriosis flares) followed by a 3-month "treatment" period (TENS unit use for endometriosis flares).
Potential subjects will be pre-screened in the Penn State Minimally Invasive GYN (MIGS) Surgery Clinic for pathologically diagnosed endometriosis and from the Penn State MIGS endometriosis database. Potential subjects will then be called to evaluate the remainder of the inclusion and exclusion criteria. If fulfilled, potential subjects will follow up at the enrollment visit (Visit 1) where consent is reviewed and signed. The baseline QOL and FSFI REDCap surveys will be completed at this visit. Subjects will be set up to receive automated links to complete diary entries and surveys directly in REDCap.
Prior to initiating TENS unit use for endometriosis flare-related pain, subjects will record daily entries into RedCap during episodes of endometriosis flares for 3 months. Each entry will record their VAS pain score as well as medication intake and bleeding profile.
Subjects will then be mailed the TENS unit at the 3 months mark into the study. Subjects will then complete entries with TENS use at their discretion for the following 3 months and record TENS unit use duration, frequency, and side effects in addition to the documentation of pain, medication and bleeding. At the end of the study, subjects will complete a QOL and FSFI survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females ages 18-45 years at time of enrollment
- •A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
- •Average monthly endometriosis pain flare
- •Naïve TENS user
排除标准
- •TENS device exclusion:
- •Implantable devices (pacemaker, Interstim, etc.)
- •Cardiac arrhythmia
- •Open skin sores over areas of placement
- •Nursing or trying to conceive at this time
- •Post-operative <12 weeks from abdominal or pelvic surgery
- •Planned surgery or hormonal medication changes for duration of study if applicable
- •Non-English speaking or inability to read and understand English
研究组 & 干预措施
Study Cohort for TENS
Subjects will be observed for 3 months (no intervention) during which time they will track endometriosis flares, followed by a 3-month intervention (TENS unit use) during endometriosis flares with diary tracking.
干预措施: Ovira Transcutaneous Electrical Nerve Stimulation Unit (Device)
结局指标
主要结局
Change in Average Daily VAS Pain Score
时间窗: Baseline period (months 1-3) and treatment period (months 4-6)
Daily pain during endometriosis flares were recorded using a Visual Analog Scale (VAS), a horizontal line measuring pain from 0 (no pain) to 100 (worst pain). Per subject, an average pain score was calculated for the baseline period (no TENS use) and treatment period (TENS use). Change (treatment minus baseline) was estimated within the context of a repeated measures model; change in the positive direction represents worse outcome, change in the negative direction represents improvement.
次要结局
- Change in Quality of Life Score From Baseline to End of Study Using the EHP30 Questionnaire(Baseline and end of study (6 months))
- Change in Female Sexual Function Index (FSFI) Total Score From Baseline to End of Study(Baseline and end of study (6 months))
研究者
Kristin Riley, MD
Assistant Professor, Obstetrics and Gynecology; Interim Chief, Minimally Invasive Gynecologic Surgery; Fellowship Program Director, Minimally Invasive Gynecologic Surgery
Milton S. Hershey Medical Center