Clinical trial NCT05866159: Effects of Kinesio Tape on Chronic Low Back Pain
Official title: The Effect of Kinesio Tape on Back-Specific Body Perception, Pain, Functional Status, and Physical Activity Level in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: functional disability
pain
kinesiotape
physical activity
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Change in The Fremantle Back Awareness Questionnaire (FreBAQ) on day 1 and day 7 (in points)
timeFrame: day 1 before the start of the kinesiotaping, day 3, and day 7
Secondary outcomes:
measure: Change in Pain Intensity (VAS) on day 0 and day 7 (in millimeters)
timeFrame: day 1 before the start of the kinesiotaping, day 3, and day 7
measure: Change in The Roland-Morris Disability Questionnaire (RMDQ) on day 1 and day 7 (in points)
timeFrame: day 1 before the start of the kinesiotaping, day 3, and day 7
measure: Change in The International Physical Activity Questionnaire - Short Form (IPAQ-SF) on day 1 and day 7 (in MET min/wk)
timeFrame: day 1 before the start of the kinesiotaping, day 3, and day 7
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kütahya Health Sciences University
name: Hakan Akkan, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.