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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain; Urinary Incontinence
• Intervention / Treatment: Behavioral: Pelvic floor muscle training; Behavioral: Pelvic floor muscle training combined with stabilization exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ibrahim Kucukcan, PHD; Phone Number: +905300351105; Email: pt.kucukcan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No application will be made until the end of this group work. After the end of the study, the effective protocol will be applied.
Active Comparator: Classic Application Group; In this group, classical pelvic floor muscle training will be applied.	Behavioral: Pelvic floor muscle training; Exercises that activate the pelvic floor muscles to strengthen and increase endurance.
Active Comparator: Study Group; The protocol determined for the study will be applied in this group. This protocol is planned as follows: It will perform stabilization exercises with the activation of the pelvic floor muscles.	Behavioral: Pelvic floor muscle training combined with stabilization exercises; While people are doing stabilization exercises, they will also work the pelvic floor muscles. Practices will be combined with breathing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Rating Scale	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'	a day before rehabilitation
Euro Quality of Life 5D-3L	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	a day before rehabilitation
Incontinence Severity Index	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.	a day before rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Oxford Scale	The Modified Oxford Scale (MOS) was used to rate pelvic floor muscle contraction on a scale of 0-511: 0 = no contraction; 1 = minor muscle 'flicker'; 2 = weak muscle contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction	a day before rehabilitation
Tampa Kinesiophobia Scale	The Tampa Scale of Kinesiophobia (TSK) that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.	a day before rehabilitation
Oswestry Disability Index	The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.	a day before rehabilitation
Pain Catastrophizing Scale	Pain catastrophizing is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event.	a day before rehabilitation
State-Trait Anxiety Inventory	The State-Trait Anxiety Inventory (STAI) is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety. Its most current revision is Form Y and it is offered in more than 40 languages	a day before rehabilitation
Incontinence Quality of Life Instrument	The I-QOL has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarrassment (5 items). It is easily self-administered and takes about 5 minutes to complete.	a day before rehabilitation
Urinary Distress Inventory	The Urogenital Distress Inventory (UDI-6) is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.	a day before rehabilitation

Collaborators and Investigators

• Sponsor: Hasan Kalyoncu University
• Investigators: Study Director: Yavuz Yakut, Professor, Hasan Kalyoncu University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: December 17, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: low back pain; Urinary Incontinence; pelvic floor muscle training; stabilization exercises
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Pain; Neurologic Manifestations; Urination Disorders; Elimination Disorders; Back Pain; Low Back Pain; Urinary Incontinence; Enuresis
• Other Study ID Numbers: Kalyoncu-kucukcan001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No