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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
McKenzie Exercises
Kinesio Tape Application
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

The control group will receive only McKenzie exercises for 7 days.

The experimental group will receive Kinesio tape application in addition to McKenzie exercises for 7 days.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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 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.

Full Information

First Posted
January 21, 2022
Last Updated
January 21, 2022
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05203783
Brief Title
Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain
Official Title
Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 8, 2021 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive only McKenzie exercises for 7 days.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group will receive Kinesio tape application in addition to McKenzie exercises for 7 days.
Intervention Type
Other
Intervention Name(s)
McKenzie Exercises
Intervention Description
McKenzie exercises: The McKenzie set consists of 5 exercises. Prone-lying Prone-extension Prone press ups Progressive extension with pillows Standing extension
Intervention Type
Other
Intervention Name(s)
Kinesio Tape Application
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
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.
Time Frame
The pain was measured at baseline
Title
Visual analogue scale (VAS)
Description
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.
Time Frame
The pain was measured at the end of intervention (7th day).
Secondary Outcome Measure Information:
Title
The Oswestry Disability Index (ODI)
Description
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.
Time Frame
The ODI was measured at study entry 2 minutes after the pain assesment.
Title
The Oswestry Disability Index (ODI)
Description
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.
Time Frame
The ODI was measured at the end of intervention (7th day) 2 minutes after the pain assesment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Marmara University
City
İstanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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