Skip to main content
Clinical Trials/NCT05666427
NCT05666427
Not yet recruiting
Not Applicable

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 sites50 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Hasan Kalyoncu University
Enrollment
50
Primary Endpoint
Numerical Pain Rating Scale
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
April 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Hasan Kalyoncu University
Responsible Party
Principal Investigator
Principal Investigator

Ibrahim Kucukcan

Principal Investigator

Hasan Kalyoncu University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Numerical Pain Rating Scale

Time Frame: 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

Time Frame: 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

Time Frame: 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

Secondary Outcomes

  • 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)

Similar Trials