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Completed

NCT Number: NCT05203783

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

McKenzie Exercises

Other

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

Other

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 outcomes

  1. Visual analogue scale (VAS)

    Time frame: The pain was measured at baseline

    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.

  2. Visual analogue scale (VAS)

    Time frame: The pain was measured at the end of intervention (7th day).

    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 outcomes

  1. The Oswestry Disability Index (ODI)

    Time frame: The ODI was measured at study entry 2 minutes after the pain assesment.

    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.

  2. The Oswestry Disability Index (ODI)

    Time frame: The ODI was measured at the end of intervention (7th day) 2 minutes after the pain assesment.

    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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2022
Registry last updated
Jan 24, 2022

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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