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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Low Back Pain, Urinary Incontinence

Intervention / Treatment
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* Behavioral: Pelvic floor muscle training combined with stabilization exercises
* Behavioral: Pelvic floor muscle training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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<br>In this group, classical pelvic floor muscle training will be applied. | Behavioral: Pelvic floor muscle training<br>* Exercises that activate the pelvic floor muscles to strengthen and increase endurance.<br>|
| Active Comparator: Study Group<br>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<br>* While people are doing stabilization exercises, they will also work the pelvic floor muscles. Practices will be combined with breathing.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, Urinary Incontinence, pelvic floor muscle training, stabilization exercises