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
- Conditions
- Urinary IncontinenceLow Back Pain
- Interventions
- Behavioral: Pelvic floor muscle trainingBehavioral: Pelvic floor muscle training combined with stabilization exercises
- Registration Number
- NCT05666427
- Lead Sponsor
- Hasan Kalyoncu University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Classic Application Group Pelvic floor muscle training In this group, classical pelvic floor muscle training will be applied. Study Group Pelvic floor muscle training combined with stabilization exercises 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.
- Primary Outcome Measures
Name Time Method Numerical Pain Rating Scale 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 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 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 Outcome Measures
Name Time Method Modified Oxford Scale a day before rehabilitation 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
Tampa Kinesiophobia Scale a day before rehabilitation 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.
Incontinence Quality of Life Instrument a day before rehabilitation 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.
Urinary Distress Inventory a day before rehabilitation The Urogenital Distress Inventory (UDI-6) is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Oswestry Disability Index a day before rehabilitation 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.
Pain Catastrophizing Scale a day before rehabilitation 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.
State-Trait Anxiety Inventory a day before rehabilitation 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