跳至主要内容
临床试验/NCT02804048
NCT02804048已完成不适用

Physiotherapy Intervention in Climacteric Women With Dyspareunia: A Randomized Controlled Trial

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain

研究概览

简要总结

Aim: To evaluate the effectiveness of physical therapy intervention techniques in the improvement of dyspareunia in climacteric women.

Study design: This is a randomized controlled trial.

详细描述

Search location: Menopause and Sexuality Clinic of the department of obstetrics and Gynecology and Clinical Research Center, Hospital de Clínicas de Porto Alegre (HCPA).

Patients or participants: The recruited patients may not be vaginal atrophy (cytology-hormone test) and must provide the diagnosis of dyspareunia for more than six months being confirmed by one of the investigators through the pain score above grade 3 (visual analog pain scale) visual inspection, palpation and a questionnaire about the duration and location of pain.

Intervention and measures: consist of evaluation of the pelvic floor muscles (Oxford Scale and Perfect), myoelectric assessment (Electromyography), quality of life (Cervantes Scale), sexual function (FSFI), level of depression (Beck Scale) and pain (visual analog pain scale) before and after physical therapy intervention.

Expected results: To estimate the effectiveness of pelvic floor training techniques with physical therapy in women with dyspareunia.

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 (Participant)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • dyspareunia complaint for at least six months
  • visual analog scale of pain above 3
  • trophic vagina

排除标准

  • vaginal atrophy
  • neurological disorders
  • lack of cognition and understanding
  • urinary tract infection and / or genital infections
  • prolapse grade 2 and 3
  • severe systemic disease
  • performing physical therapy

结局指标

主要结局

To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain

时间窗: Seven meetings, twice a week, in which the first is the initial assessment and the seventh is the final evaluation totaling a maximum of one month treatment for each patient.

To evaluate the effectiveness of physiotherapy techniques using the analog pain scale.

次要结局

  • To evaluate depression(To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention)
  • To evaluate the pelvic floor muscle function(To evaluate the pelvic floor muscle function, using PERFECT Scale in baseline and after four weeks of intervention)
  • To evaluate sexual function(To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention)
  • To evaluate the quality of life(To evaluate the quality of life, using Cervantes Scale in climateric women in baseline and after four weeks of intervention)
  • To evaluate electrical activity of the pelvic floor muscles(To evaluate electrical activity of the pelvic floor muscles, using Electromyographic biofeedback , in baseline and after four weeks of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验