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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666427
• Other study ID #: Kalyoncu-kucukcan001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 1, 2023

Study information

• Verified date: December 2022
• Source: Hasan Kalyoncu University
• Contact: Ibrahim Kucukcan, PHD
• Phone: +905300351105
• Email: pt.kucukcan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Enuresis
• Low Back Pain
• Urinary Incontinence

Intervention

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.
• Pelvic floor muscle training
Exercises that activate the pelvic floor muscles to strengthen and increase endurance.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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