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

Primary Purpose

Pregnancy-related Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio tape application and Core stabilization home program
Core stabilization home program
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy-related Low Back Pain focused on measuring Pregnancy, Low back pain, Function, Kinesiologic tape, core stabilization

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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). Exclusion Criteria: Known or suspected orthopedic or rheumatological disorders such as scoliosis, spinal injuries, ankylosing spondylitis or rheumatoid arthritis; intervertebral disc pathology; a history of low back pain before pregnancy; twin pregnancy or fetal anomaly; and any uncontrolled medical conditions

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinesiotape application

Core stability and pelvic floor exercises group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change from Baseline pregnancy-related low back Pain at 4 weeks
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
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
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.

Full Information

First Posted
April 18, 2023
Last Updated
July 15, 2023
Sponsor
KTO Karatay University
Collaborators
HASAN GERÇEK, ŞERİFE İREM DÖNER, BAYRAM SÖNMEZ ÜNÜVAR
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1. Study Identification

Unique Protocol Identification Number
NCT05847946
Brief Title
The Effect of Kinesio Taping on Pain and Quality of Life in Pregnancy-Related Low Back Pain
Official Title
The Effect of Kinesio Taping on Pain and Quality of Life in Pregnancy-Related Low Back Pain: A Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 4, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KTO Karatay University
Collaborators
HASAN GERÇEK, ŞERİFE İREM DÖNER, BAYRAM SÖNMEZ ÜNÜVAR

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy-related Low Back Pain
Keywords
Pregnancy, Low back pain, Function, Kinesiologic tape, core stabilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Core stability and pelvic floor exercises will be compared with kinesiotape application.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotape application
Arm Type
Experimental
Arm Description
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.
Arm Title
Core stability and pelvic floor exercises group
Arm Type
Active Comparator
Arm Description
Participants will perform core stabilization and pelvic floor exercises 5 days a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Kinesio tape application and Core stabilization home program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Core stabilization home program
Intervention Description
Core stabilization exercises will be given to the participants as a home exercise program.
Primary Outcome Measure Information:
Title
Change from Baseline pregnancy-related low back Pain at 4 weeks
Description
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.
Time Frame
Baseline and after 4 weeks intervention
Title
Change from Baseline Function at 4 weeks
Description
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.
Time Frame
Baseline and after 4 weeks intervention
Secondary Outcome Measure Information:
Title
Change from Baseline Health Quality at 4 weeks
Description
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.
Time Frame
Baseline and after 4 weeks interventionBaseline and after 4 weeks intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women will be included in the study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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). Exclusion Criteria: Known or suspected orthopedic or rheumatological disorders such as scoliosis, spinal injuries, ankylosing spondylitis or rheumatoid arthritis; intervertebral disc pathology; a history of low back pain before pregnancy; twin pregnancy or fetal anomaly; and any uncontrolled medical conditions
Facility Information:
Facility Name
KTO Karatay University
City
Konya
State/Province
Karatay
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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