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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05666427
Enrollment
50
Registered
2022-12-27
Start date
2023-01-01
Completion date
2023-04-01
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Urinary Incontinence

Keywords

low back pain, Urinary Incontinence, pelvic floor muscle training, stabilization exercises

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.

Interventions

BEHAVIORALPelvic floor muscle training

Exercises that activate the pelvic floor muscles to strengthen and increase endurance.

BEHAVIORALPelvic 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.

Sponsors

Hasan Kalyoncu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Numerical Pain Rating Scalea day before rehabilitationIn 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'
Euro Quality of Life 5D-3La day before rehabilitationThe 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
Incontinence Severity Indexa day before rehabilitationThe 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.

Secondary

MeasureTime frameDescription
Pain Catastrophizing Scalea day before rehabilitationPain 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 Inventorya day before rehabilitationThe 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
Modified Oxford Scalea day before rehabilitationThe 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
Urinary Distress Inventorya day before rehabilitationThe Urogenital Distress Inventory (UDI-6) is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Incontinence Quality of Life Instrumenta day before rehabilitationThe 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.
Tampa Kinesiophobia Scalea day before rehabilitationThe 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.
Oswestry Disability Indexa day before rehabilitationThe 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.

Contacts

Primary ContactIbrahim Kucukcan, PHD
pt.kucukcan@gmail.com+905300351105

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026