Low Back Pain Clinical Trial
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
Verified date | September 2023 |
Source | Kutahya Health Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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, |
Country | Name | City | State |
---|---|---|---|
Turkey | Kutahya Health Sciences University | Kütahya |
Lead Sponsor | Collaborator |
---|---|
Kutahya Health Sciences University |
Turkey,
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
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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