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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05666427
Other study ID # Kalyoncu-kucukcan001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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