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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: McKenzie Exercises; Other: Kinesio Tape Application

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34000
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; The control group will receive only McKenzie exercises for 7 days.	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; Other: 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
Experimental: Experimental Group; The experimental group will receive Kinesio tape application in addition to McKenzie exercises for 7 days.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2021
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): December 25, 2021

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2021-1039

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