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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05866159
Other study ID # KutahyaHSU-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2023
Est. completion date September 20, 2023

Study information

Verified date September 2023
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 20, 2023
Est. primary completion date August 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 taping
sham taping with Rocktape®, with no tension.

Locations

Country Name City State
Turkey Kutahya Health Sciences University Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & 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. Erratum In: J Physiother. 2012;58(3):143. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in Pain Intensity (VAS) on day 0 and day 7 (in millimeters) 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
Secondary Change in The Roland-Morris Disability Questionnaire (RMDQ) on day 1 and day 7 (in points) 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
Secondary Change in The International Physical Activity Questionnaire - Short Form (IPAQ-SF) on day 1 and day 7 (in MET min/wk) 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
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