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临床试验/NCT07253766
NCT07253766
已完成
不适用

The Effectiveness of Kinesiologic Taping in Patients With Knee Rheumatoid Arthritis in Terms of Pain, Function, and Kinesiophobia: A Randomised Controlled Trial

Istanbul Rumeli University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月1日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Istanbul Rumeli University
入组人数
30
试验地点
1
主要终点
Visual Analog Scale

概览

简要总结

The goal of this clinical trial is to learn if kinesiologic taping works to treat individuals with Rheumatoid Arthritis.

The main questions it aim to answer:

  • Is kinesiologic taping applied to the knee joint an effective treatment for pain, mobility, and kinesiophobia in individuals diagnosed with rheumatoid arthritis?
  • Which is more effective? Kinesiologic taping or non-therapeutic sham taping? Which is better for pain, functional capacity, kinesiophobia and disease activity? Researchers will compare kinesiologic taping and non-therapeutic sham taping . Patients will be randomly divided into groups. The first group of patients was treated with sham taping, and the application period was applied consecutively for 4 weeks, with a minimum interval of 3 days and a maximum interval of 5 days. Group 2 patients underwent kinesiological taping, with the application period ranging from 3 to 5 days per week for 4 consecutive weeks.

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
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 45 to 60
  • Patients diagnosed with acute or chronic rheumatoid arthritis;
  • Patients whose rheumatic medication protocol has not changed in the last 3 months; -Patients who do not smoke, drink alcohol or use drugs;
  • Patients who have no vision, hearing or speech problems;
  • Patients who are not amputees;
  • Patients who can walk independently.

排除标准

  • individuals over the age of 61;
  • individuals with neurological disorders, severe chronic obstructive pulmonary disease, liver or kidney failure, malignancies, uncontrolled diabetes mellitus, major psychiatric disorders, or pregnancy; and those with concomitant conditions that could cause balance problems.
  • Pregnant and breastfeeding women;
  • individuals who had undergone surgery in the last few months;
  • patients with loss of cooperation (e.g., those diagnosed with dementia or Alzheimer's disease) were also excluded from the study.

结局指标

主要结局

Visual Analog Scale

时间窗: Four Weeks

A Visual Analog scale(VAS) was used to assess pain intensity. Participants were asked to rate their perceived pain on a 10-cm horizontal line, where 0 cm indicates "no pain" and 10 cm indicates "worst pain imaginable." The participants marked a point on the line that best represented their pain intensity at rest and during activity. The distance (in centimeters) from the "no pain" end to the participant's mark was measured and recorded as the VAS score.

Tampa Kinesiophobia Scale

时间窗: Four Weeks

Kinesiophobia was assessed using the Tampa Scale for Kinesiophobia (TSK), a self-report questionnaire designed to measure fear of movement or re-injury. The scale consists of 17 items, each rated on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). Higher scores indicate a greater degree of kinesiophobia, with a total score range between 17 and 68 points.

Timed up and Go test

时间窗: Four weeks

Functional mobility was assessed using the Timed Up and Go (TUG) test, a simple and reliable measure of dynamic balance and mobility. Participants were instructed to rise from a standard chair, walk three meters, turn around, walk back, and sit down at their normal walking speed. The time taken to complete the task was measured in seconds using a stopwatch. Shorter completion times indicate better functional mobility.

Disease Activity

时间窗: Four weeks

Disease activity was evaluated using the Disease Activity Score-28 (DAS28), which incorporates the number of tender and swollen joints (out of 28), the erythrocyte sedimentation rate (ESR), and the patient's global health assessment (GH) on a 100-mm Visual Analog Scale. The DAS28 score was calculated according to the standard formula, with values below 2.6 indicating remission, 2.6-3.2 low disease activity, 3.2-5.1 moderate activity, and above 5.1 high disease activity. This index is widely used to monitor disease progression and treatment response in patients with rheumatoid arthritis.

次要结局

未报告次要终点

研究者

发起方
Istanbul Rumeli University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozden Baskan

Assist.Prof

Istanbul Rumeli University

研究点 (1)

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