Effects of Kinesio Tape on Chronic Low Back Pain

September 25, 2023 updated by: Hakan AKKAN, Kutahya Health Sciences University

The Effect of Kinesio Tape on Back-Specific Body Perception, Pain, Functional Status, and Physical Activity Level in Patients With Chronic Low Back Pain

This clinical trial aims to examine kinesiotape's (KT) short-term effect on individuals with nonspecific chronic LBP (CLBP), including back-specific body perception, pain, functional disability, and physical activity. The hypothesis is that applying KT to the lumbar spine would improve back-specific body perception, reduce pain and functional disability, and increase physical activity in individuals with CLBP compared to the sham-taping group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low back pain (LBP) is prevalent and the leading cause of disability worldwide. In addition, it is often associated with psychological, social, and physical factors that can impact one's ability to function, participate in society, maintain job satisfaction, and socioeconomic status. Therefore, managing it requires a significant amount of healthcare resources. Maladaptive body image and maladaptive beliefs are among the conditions that can be targeted during treatment as they may contribute to the chronicity of LBP.

This clinical trial aims to examine kinesiotape's (KT) short-term effect on individuals with nonspecific chronic LBP (CLBP), including back-specific body perception, pain, functional disability, and physical activity. The hypothesis is that applying KT to the lumbar spine would improve back-specific body perception, reduce pain and functional disability, and increase physical activity in individuals with CLBP compared to the sham-taping group.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kütahya, Turkey
        • Kutahya Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ability to speak and write Turkish fluently
  • have been experiencing low back pain for at least 3 months
  • have a pain severity score of ≥4 on the visual analog scale

Exclusion Criteria:

  • had significant spinal surgery in the past (fusion or discectomy), spinal surgery within the last six months,
  • a diagnosis of a serious spinal condition (such as cancer, inflammatory arthropathy, or vertebral fracture),
  • skin allergy to KT or pre-existing skin lesion or infection
  • a neurological disease,
  • is currently pregnant,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Intervention
The experimental group will receive double-sided I-shaped kinesiotape. The tape will be applied from the sacroiliac joint to the thoracic 12th vertebrae, with a 10-15% tension. During the application, the participant will be positioned in maximum torso flexion.
Other: Kinesiotape using Rocktape®
Kinesiotape using Rocktape® on day one by a physiotherapist who has experienced more than five years. If possible, the taping will be left for seven days.
Sham Comparator: Control Intervention
For the sham group, the kinesiotape will be applied horizontally to the center of the painful area in the lumbar region without any tension (at 0%).
Other: Sham taping
sham taping with Rocktape®, with no tension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in The Fremantle Back Awareness Questionnaire (FreBAQ) on day 1 and day 7 (in points)
Time Frame: day 1 before the start of the kinesiotaping, day 3, and day 7
The Fremantle Back Awareness Questionnaire (FreBAQ) is a tool used to measure a patient's perception of their back. It consists of nine questions rated on a five-point scale, ranging from "0=never" to "4=always".
day 1 before the start of the kinesiotaping, day 3, and day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity (VAS) on day 0 and day 7 (in millimeters)
Time Frame: day 1 before the start of the kinesiotaping, day 3, and day 7
Patients will score their low-back pain intensity over the past week on a horizontal 10 cm line with descriptive anchors at each end, such as on the right, "no pain" to the left, and "extreme pain."
day 1 before the start of the kinesiotaping, day 3, and day 7
Change in The Roland-Morris Disability Questionnaire (RMDQ) on day 1 and day 7 (in points)
Time Frame: day 1 before the start of the kinesiotaping, day 3, and day 7
The RMDQ evaluates self-reported physical disability resulting from low back pain. The RMDQ questionnaire consists of 24 items. Each item is scored as "0" if left blank or "1" if endorsed. The total RMQ score ranges from 0 to 24, with higher scores indicating more pain-related disability.
day 1 before the start of the kinesiotaping, day 3, and day 7
Change in The International Physical Activity Questionnaire - Short Form (IPAQ-SF) on day 1 and day 7 (in MET min/wk)
Time Frame: day 1 before the start of the kinesiotaping, day 3, and day 7
The IPAQ was developed to assess physical activity internationally. There are two versions of the International Physical Activity Questionnaire (IPAQ): the long form with 31 items (IPAQ-LF) and the short form with nine items (IPAQ-SF). The IPAQ-SF measures activity in four different intensity levels, including 1)vigorous activities, 2) moderate activities, 3) walking, and 4) sitting.
day 1 before the start of the kinesiotaping, day 3, and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya Health Sciences University

Investigators

  • Principal Investigator: Hakan Akkan, PhD, PT, Kutahya Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2023

Primary Completion (Actual)

August 25, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KutahyaHSU-003

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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