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临床试验/NCT05866159
NCT05866159已完成不适用

The Effect of Kinesio Tape on Back-Specific Body Perception, Pain, Functional Status, and Physical Activity Level in Patients With Chronic Low Back Pain

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Change in The Fremantle Back Awareness Questionnaire (FreBAQ) on day 1 and day 7 (in points)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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,

结局指标

主要结局

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

时间窗: day 1 before the start of the kinesiotaping, day 3, and day 7

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".

次要结局

  • 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)
  • 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)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan AKKAN

PhD, PT

Kutahya Health Sciences University

研究点 (1)

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