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Completed

NCT Number: NCT05847946

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesio tape application and Core stabilization home program

Other

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.

Core stabilization home program

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Collaborators

  • BAYRAM SÖNMEZ ÜNÜVAR
  • Hasan Gerçek
  • ŞERİFE İREM DÖNER

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 8, 2023
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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