Effects of Kinesio Tape on Chronic Low Back Pain

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.

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Kinesiotape using Rocktape®
* Other: Sham taping


Participation Criteria
=================
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,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Intervention<br>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®<br>* 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.<br>|
| Sham Comparator: Control Intervention<br>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<br>* sham taping with Rocktape®, with no tension.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional disability, pain, kinesiotape, physical activity