NCT05203783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

January 21, 2022

Last Update Submit

January 21, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • The Oswestry Disability Index (ODI)

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

  • The Oswestry Disability Index (ODI)

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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: McKenzie ExercisesOther: Kinesio Tape Application

Experimental Group

EXPERIMENTAL

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

Other: Kinesio Tape Application

Interventions

McKenzie exercises: The McKenzie set consists of 5 exercises. 1. Prone-lying 2. Prone-extension 3. Prone press ups 4. Progressive extension with pillows 5. Standing extension

Control Group

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

Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals diagnosed with mechanical LBP by a physician

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2022

First Posted

January 24, 2022

Study Start

August 8, 2021

Primary Completion

December 10, 2021

Study Completion

December 25, 2021

Last Updated

January 24, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations