Combined Effects of Soft Tissue Mobilization and Pelvic Floor Muscle Exercises on Pain, Sexual Life Quality and Functional Mobility in Women With Post-operative Adhesions After Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Numeric pain rating scale
研究概览
简要总结
Adhesions are permanent tissue connections that are created by fibrin deposition between different tissue planes or organs. They are a part of the internal healing process and inflammatory reactions that go through several overlapping phases, including the proliferative phase, remodeling phase, and hemostasis/inflammatory phase. Adhesions are typically the body's defense mechanisms against various triggers of inflammation, including physical, chemical, and infections. These triggers can have unfavorable consequences, including chronic pain, obstruction (particularly bowel), functional impairment, and infertility. This may cause adjacent structures to lose their flexibility and mobility. The nonsurgical treatment of symptoms thought to be associated with adhesions has centered on several methods of soft tissue scar removal.
详细描述
This study will be randomized controlled trial and will be conducted in Hanif medical center and poly clinic and Lady willingdon hospital. The total duration of treatment will be 10 week.
Non-probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive soft tissue mobilization of pelvic area with pelvic floor muscle exercises and Group B will receive soft tissue mobilization of pelvic area without pelvic floor muscle exercises after heating for 10 minutes as baseline treatment. The tools that will be used are Numeric Pain Rating Scale (NPRS), Female Sexual Function Index (FSFI) and Functional status questionnaire (FSQ). After data collection data will be analyzed by using SPSS version 25.
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
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Married women
- •Age 40-60 years
- •BMI below 30 (13)
- •Women with post-operative pelvic adhesions (14)
- •Women after hysterectomy (3 months after surgery)
排除标准
- •Women with any other surgery
- •Women with failed pelvic surgery (14)
- •Post-operative women with open wound (unhealed suture site) (14)
- •Women with uncontrolled hypertension, thrombophlebitis, hematoma, osteomyelitis, myositis ossificans and malignancy
结局指标
主要结局
Numeric pain rating scale
时间窗: 6 weeks
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
Female sexual function index
时间窗: 6 weeks
The FSFI questionnaire consists of 19 close-ended questions related to sexual activity and includes six domains: * Sexual desire (question number 1-2) * Sexual arousal (question number 3-6) * Lubrication (question number 7-10) * Orgasm (question number 11-13) * Sexual satisfaction (question number 14-19)
Functional status questionnaire
时间窗: 6 weeks
The Functional Status Questionnaire (FSQ) is a brief, self-administered questionnaire developed by researchers from Boston's Beth Israel Hospital and the University of California at Los Angeles. The FSQ was designed to screen for disability and to monitor clinically meaningful change in function.
次要结局
未报告次要终点