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

February 28, 2024 updated by: Hafize Dağ Tüzmen, KTO Karatay University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Karatay
      • Konya, Karatay, Turkey
        • KTO Karatay University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline pregnancy-related low back Pain at 4 weeks
Time Frame: 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.
Baseline and after 4 weeks intervention
Change from Baseline Function at 4 weeks
Time Frame: 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.
Baseline and after 4 weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Health Quality at 4 weeks
Time Frame: 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.
Baseline and after 4 weeks interventionBaseline and after 4 weeks intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KTO Karatay University

Collaborators

HASAN GERÇEK
ŞERİFE İREM DÖNER
BAYRAM SÖNMEZ ÜNÜVAR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2023

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kinesio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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