Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain

Low Back Pain Clinical Trial

Official title:

Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain: A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05203783
• Other study ID #: 2021-1039
• Status: Completed
• Phase: N/A
• Start date: August 8, 2021
• Est. completion date: December 25, 2021

Study information

• Verified date: January 2022
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to estimate the effect of Kinesio tape (KT) combined with supervised exercise programs compared to exercise alone on pain, lumbar range of motion, and self-reported disability of adults with mechanical low back pain (LBP). Methods: This was a randomized, controlled clinical trial carried out on 60 individuals with mechanical LBP. Participants were randomly assigned to the control group (n=30) that received McKenzie exercises for 7 days or experimental group (n=30) that received KT application in addition to McKenzie exercises for 7 days. Pain measured by visual analogue scale, lumbar range of motion, and the disability measured by Oswestry Disability Index (ODI) were used as outcome measures. Pre and Post measurements were taken at baseline and after 7 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 25, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Individuals diagnosed with mechanical LBP by a physician

Exclusion Criteria:

• Individuals with any structural or pathological changes (spondylitis, spondylolisthesis, cauda equina syndrome, lumbar canal stenosis) in lumbar spine on X-ray or MRI
• Individuals with or without neurological signs in the lower extremity suggestive upper motor or lower motor neuron involvement,
• Individuals with a history of trauma or any surgery in the region of back,
• Individuals with recent aggravation of symptoms,
• Individuals on a waiting list for spinal surgery or had a spinal surgery in the past 6 months

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• McKenzie Exercises
McKenzie exercises: The McKenzie set consists of 5 exercises. Prone-lying Prone-extension Prone press ups Progressive extension with pillows Standing extension
• Kinesio Tape Application
Kinesio Tape (KT) application: Participants in the experimental group received additional taping using KT by an experience therapist with prior training in KT application. The tape was applied using the method proposed for the sacrospinalis muscle (Kase, 1996). Y-shaped tape was applied as shown in Figure 1. While the participant was in standing position, the origin of the Y-shaped tape was attached over the centre of the sacrum without stretching the tape and afterward subjects gradually bent forward. A 5-degree angle was maintained within the valley of the Y tape. The tape was changed on the fourth day

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (VAS)	Pain was measured using a 10 cm visual analogue scale (VAS). The participants placed a mark on the line that best represented their perception of pain at that instant. The VAS score was measured in cm from the left hand end of the line to the mark.	The pain was measured at baseline
Primary	Visual analogue scale (VAS)	Pain was measured using a 10 cm visual analogue scale (VAS). The participants placed a mark on the line that best represented their perception of pain at that instant. The VAS score was measured in cm from the left hand end of the line to the mark.	The pain was measured at the end of intervention (7th day).
Secondary	The Oswestry Disability Index (ODI)	The ODI was used to assess the disability. The ODI is a valid and reliable tool that measures functional disability. The scale consists of 10 sections, each section the total possible score is ranging from 0 to 5. After that, the entire score is multiplied by two to get a percentage.	The ODI was measured at study entry 2 minutes after the pain assesment.
Secondary	The Oswestry Disability Index (ODI)	The ODI was used to assess the disability. The ODI is a valid and reliable tool that measures functional disability. The scale consists of 10 sections, each section the total possible score is ranging from 0 to 5. After that, the entire score is multiplied by two to get a percentage.	The ODI was measured at the end of intervention (7th day) 2 minutes after the pain assesment.