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Clinical Trials/NCT05866159
NCT05866159CompletedNot Applicable

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

Kutahya Health Sciences University1 site in 1 country60 target enrollmentStarted: May 29, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Change in The Fremantle Back Awareness Questionnaire (FreBAQ) on day 1 and day 7 (in points)

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

A double-blinded design will be conducted to assess the effectiveness of kinesio versus sham tape, as patients cannot distinguish between the two.

The assessment of back-specific body perception, which is the primary outcome, will be conducted by an assessor unaware of the treatment allocation prior to treatment, as well as on days 3 and 7.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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,

Outcomes

Primary Outcomes

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".

Secondary Outcomes

  • Change in The Roland-Morris Disability Questionnaire (RMDQ) on day 1 and day 7 (in points)(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)(day 1 before the start of the kinesiotaping, day 3, and day 7)
  • Change in Pain Intensity (VAS) on day 0 and day 7 (in millimeters)(day 1 before the start of the kinesiotaping, day 3, and day 7)

Investigators

Sponsor
Kutahya Health Sciences University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hakan AKKAN

PhD, PT

Kutahya Health Sciences University

Study Sites (1)

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