Effects of Kinesio Tape on Chronic Low Back Pain

NCT05866159 | Completed

• 1 other identifier: KutahyaHSU-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

functional disability; pain; kinesiotape; physical activity

Outcome Measures

Primary Outcomes (1)

• Change in The Fremantle Back Awareness Questionnaire (FreBAQ) on day 1 and day 7 (in points)

  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 Outcomes (3)

• 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

• 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

Study Arms (2)

Experimental Intervention

EXPERIMENTAL

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®

Control Intervention

SHAM COMPARATOR

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

Interventions

Kinesiotape using Rocktape® OTHER

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.

Experimental Intervention

Sham taping OTHER

sham taping with Rocktape®, with no tension.

Control Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

Location

Related Publications (6)

• Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. J Physiother. 2012;58(2):89-95. doi: 10.1016/S1836-9553(12)70088-7.

  PMID: 22613238 BACKGROUND

• Koroglu F, Colak TK, Polat MG. The effect of Kinesio(R) taping on pain, functionality, mobility and endurance in the treatment of chronic low back pain: A randomized controlled study. J Back Musculoskelet Rehabil. 2017 Sep 22;30(5):1087-1093. doi: 10.3233/BMR-169705.

  PMID: 28968232 BACKGROUND

• Luz Junior MA, Sousa MV, Neves LA, Cezar AA, Costa LO. Kinesio Taping(R) is not better than placebo in reducing pain and disability in patients with chronic non-specific low back pain: a randomized controlled trial. Braz J Phys Ther. 2015 Nov-Dec;19(6):482-90. doi: 10.1590/bjpt-rbf.2014.0128. Epub 2015 Oct 9.

  PMID: 26647750 BACKGROUND

• Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18.

  PMID: 27327235 BACKGROUND

• Erol E, Yildiz A, Yildiz R, Apaydin U, Gokmen D, Elbasan B. Reliability and Validity of the Turkish Version of the Fremantle Back Awareness Questionnaire. Spine (Phila Pa 1976). 2019 May 1;44(9):E549-E554. doi: 10.1097/BRS.0000000000002909.

  PMID: 30325886 BACKGROUND

• Macedo LB, Richards J, Borges DT, Melo SA, Brasileiro JS. Kinesio Taping reduces pain and improves disability in low back pain patients: a randomised controlled trial. Physiotherapy. 2019 Mar;105(1):65-75. doi: 10.1016/j.physio.2018.07.005. Epub 2018 Jul 26.

  PMID: 30348455 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Hakan Akkan, PhD, PT

  Kütahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, PT

Model Details: comparing the use of kinesiotape for the treatment of back-specific body image, pain, functional disability, and physical activity of individuals with non-specific CLBP to sham-taping

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: May 29, 2023
• Primary Completion: August 25, 2023
• Study Completion: September 20, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)