The Effect of Kinesio Taping on Pain and Quality of Life in Pregnancy-Related Low Back Pain

Sponsor

KTO Karatay University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05847946

Collaborator

HASAN GERÇEK (Other), ŞERİFE İREM DÖNER (Other), BAYRAM SÖNMEZ ÜNÜVAR (Other)

Enrollment

Arms

1.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Pregnant women may experience pregnancy-related low back pain and this pain may negatively affect function. There are studies in the literature that Kinesiotape applications improve pain. There is no study examining the effect of Kinesiotape application in addition to exercise on pregnancy-related low back pain and function. At the end of our study, we will compare the effects of Kinesiotape application for a total of 8 sessions for 4 weeks on pain and function.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy-related Low Back Pain	Other: Kinesio tape application and Core stabilization home program Other: Core stabilization home program	N/A

Detailed Description

Kinesio tape (KT) application is a physiotherapy method whose use has increased in recent years in the treatment of chronic pain. Kinesio tape, an alternative method to support fascia, muscles and joints, Dr. Developed by Kenzo Kase. Although the therapeutic effects of the KT method are still unclear, the putative therapeutic effects include facilitating muscle activity, providing sensory stimuli to the skin, muscles or facial structures, and regulating joint range of motion (ROM) . KT method increases blood and lymph circulation by lifting the skin, and prevents pain by reducing nociceptive stimuli . KT has been administered to pregnancy to improve low back pain. In addition to publications showing that KT can reduce pregnancy-related low back pain, there are studies showing that it has no effect compared to the control group . The aim of this study is to examine the effect of 8 sessions of KT applied in addition to 4-week core stabilization exercises on pain and quality of life in pregnant women with pregnancy-related low back pain.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Core stability and pelvic floor exercises will be compared with kinesiotape application.Core stability and pelvic floor exercises will be compared with kinesiotape application.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Kinesio Taping on Pain and Quality of Life in Pregnancy-Related Low Back Pain: A Randomized Clinical Study

Anticipated Study Start Date :

May 3, 2023

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kinesiotape application In addition to core stabilization and pelvic floor exercises, kinesiotape will be applied to the paraspinal muscles in the lumbar region 2 times a week for a total of 8 times.	Other: Kinesio tape application and Core stabilization home program Participants in the kinesiotape group will receive 2 sessions of kinesiotape per week, in addition to the core stabilization home program, 5 days a week for 4 weeks.
Active Comparator: Core stability and pelvic floor exercises group Participants will perform core stabilization and pelvic floor exercises 5 days a week for 4 weeks.	Other: Core stabilization home program Core stabilization exercises will be given to the participants as a home exercise program.

Arm

Intervention/Treatment

Experimental: Kinesiotape application

In addition to core stabilization and pelvic floor exercises, kinesiotape will be applied to the paraspinal muscles in the lumbar region 2 times a week for a total of 8 times.

Other: Kinesio tape application and Core stabilization home program

Participants in the kinesiotape group will receive 2 sessions of kinesiotape per week, in addition to the core stabilization home program, 5 days a week for 4 weeks.

Active Comparator: Core stability and pelvic floor exercises group

Participants will perform core stabilization and pelvic floor exercises 5 days a week for 4 weeks.

Other: Core stabilization home program

Core stabilization exercises will be given to the participants as a home exercise program.

Outcome Measures

Primary Outcome Measures

Change from Baseline pregnancy-related low back Pain at 4 weeks [Baseline and after 4 weeks intervention]
Pain will be assessed with a 10 cm visual analog scale at night, at rest and during activity. "0" means no pain and "10" means unbearable pain. The assessment will be done before and at the end of the study.
Change from Baseline Function at 4 weeks [Baseline and after 4 weeks intervention]
Function will be assessed with the Oswestry Low Back Pain Disability Questionnaire. The higher the score on the scale, the greater the loss of function. Assessment will be done before and at the end of the study.

Secondary Outcome Measures

Change from Baseline Health Quality at 4 weeks [Baseline and after 4 weeks interventionBaseline and after 4 weeks intervention]
Quality of life will be assessed with the Short Form 36. The higher the score on the scale, the better the quality of life. The assessment will be done before and at the end of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Maternal age between 18 and 40 years, any birth,
gestational age between 13 and 30 weeks,
low back pain anywhere from T12 to gluteal fold without leg pain and at least moderate pain intensity (VAS ≥ 4).