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

Pregnancy-related Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05847946
• Other study ID #: Kinesio
• Status: Completed
• Phase: N/A
• Start date: June 4, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: February 2024
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 30, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pregnancy-related Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	KTO Karatay University	Konya	Karatay

Sponsors (4)

Lead Sponsor	Collaborator
KTO Karatay University	BAYRAM SÖNMEZ ÜNÜVAR, HASAN GERÇEK, SERIFE IREM DÖNER

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and after 4 weeks intervention
Primary	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.	Baseline and after 4 weeks intervention
Secondary	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.	Baseline and after 4 weeks interventionBaseline and after 4 weeks intervention