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临床试验/NCT05666427
NCT05666427尚未招募不适用

Investigation of the Effect of Pelvic Floor Muscle Training Combined With Stabilization Exercises on Pain and Urinary Parameters in Individuals With Low Back Pain With Urinary Incontinence

Hasan Kalyoncu University0 个研究点目标入组 50 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
Numerical Pain Rating Scale

研究概览

简要总结

The research will be done with people with urinary incontinence and low back pain. 3 groups of volunteer participants will be formed. The groups were planned as study group, classical application group and control group. Classical pelvic floor muscle training will be applied to the classical application group. Pelvic floor muscle training combined with stabilization exercises will be applied to the study group. In this study, the effect of pelvic floor muscle training combined with stabilization exercises on pain and urinary parameters compared to classical pelvic floor muscle training will be investigated in people with urinary incontinence and low back pain at the same time.

详细描述

The rehabilitation period in the study was determined as 2 months. Participants will receive treatment with a supervisor 1 or 2 days a week. On other days, they will continue as a home program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Those with low back pain for at least 3 months (at least once a week with low back pain)
  • Those with urinary incontinence
  • 4 and above according to Numerical Pains Rating Scale
  • At least 20% according to the Oswestry Disability Index
  • Body Mass Index 30 and below

排除标准

  • Those who have undergone lumbar or pelvic surgery in the last 6 months
  • Those who received pelvic floor muscle training in the last 3 months
  • Systemic, inflammatory, rheumatic, malignant, osseous pathologies etc. that may cause low back pain. those with diseases
  • Those who are pregnant
  • Stage 3-4 of pelvic organ prolapse
  • Those who are pregnant

结局指标

主要结局

Numerical Pain Rating Scale

时间窗: a day before rehabilitation

In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'

Incontinence Severity Index

时间窗: a day before rehabilitation

The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe.

Euro Quality of Life 5D-3L

时间窗: a day before rehabilitation

The EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease

次要结局

  • Modified Oxford Scale(a day before rehabilitation)
  • Tampa Kinesiophobia Scale(a day before rehabilitation)
  • Incontinence Quality of Life Instrument(a day before rehabilitation)
  • Urinary Distress Inventory(a day before rehabilitation)
  • Oswestry Disability Index(a day before rehabilitation)
  • Pain Catastrophizing Scale(a day before rehabilitation)
  • State-Trait Anxiety Inventory(a day before rehabilitation)

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Kucukcan

Principal Investigator

Hasan Kalyoncu University

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