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

NCT ID: NCT05666427

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-04-01

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.

Conditions

Low Back Pain; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

No application will be made until the end of this group work. After the end of the study, the effective protocol will be applied.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Classic Application Group

In this group, classical pelvic floor muscle training will be applied.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training

Intervention Type: BEHAVIORAL

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

Study Group

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.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training combined with stabilization exercises

Intervention Type: BEHAVIORAL

While people are doing stabilization exercises, they will also work the pelvic floor muscles. Practices will be combined with breathing.

Interventions

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.

Intervention Type: BEHAVIORAL

Pelvic floor muscle training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hasan Kalyoncu University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Kucukcan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yavuz Yakut, Professor

Role: STUDY_DIRECTOR

Hasan Kalyoncu University

Central Contacts

Ibrahim Kucukcan, PHD

Role: CONTACT

pt.kucukcan@gmail.com

+905300351105

References

Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

Reference Type: DERIVED

PMID: 39704322 (View on PubMed)

Other Identifiers

Kalyoncu-kucukcan001

Identifier Type: -

Identifier Source: org_study_id