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临床试验/NCT05515965
NCT05515965已完成不适用

Acute Effect of Kinesiotaping Applied to the Thumb in Patients With Rheumatoid Hand

Istanbul Arel University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年4月1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
34
试验地点
2
主要终点
Subjective Pain Intensity

研究概览

简要总结

Objective: It was aimed to evaluate the acute effect of Kinesiotape taping on pain, function, range of motion and grip strength parameters in patients with rheumatoid arthritis and hand involvement.

Material and Methods: A total of 34 patients, 27 women and 7 men, diagnosed with RA according to the American Rheumatism Association (ACR) criteria were included in our study. All patients were divided into two groups as Kinesiotape and Control groups, each consisting of 17 patients. Subjective pain intensity was evaluated with the Visual Analog Scale, range of motion was evaluated with a goniometer, functional evaluation was evaluated with the Grip Skill Test, hand grip strength was evaluated with a dynamometer, and finger grip strength was evaluated with a pinchmeter. Evaluation parameters were evaluated before and 1 hour after the application, and the acute effect was examined. The patients in the kinesiotape group were taped with the mechanical correction method and the patients in the Control group were taped with tensionless gluing of the I tape. Applications were made on both dominant and nondominant hands.

详细描述

This study is a double-blind, randomized clinical trial conducted by the Non-Interventional Ethics Committee from April 2018 to October 2018 in the Rheumatology unit of a university hospital in Turkey. The patients were divided in two groups using simple randomization method. There are 17 patients in groups. As the evaluation content; Socio-demographic information was recorded. Pain assessment was done by participants' subjective pain intensity Visual Analogue scale, mobility assessment was made by evaluating the range of motion with a goniometer, functional assessment was by grasping skill test, hand grip strength was measured by dynamometer, and finger grip strength was measured by pinchmeter. In our study, the mechanical correction method of taping to the Kinesiotape group was used. In rheumatoid hand patients, due to the presence of a deformity called hitchhiker's finger, the thumb is taped with 50-75% tension to create a pulling force in the direction of flexion and abduction. Sham application was applied to both dominant and nondominant hands in Control Group patients. Sham taping is the bonding of I tape to the 1st finger without tension and does not contain any features. Both the dominant and nondominant hands of the patients were taped and the differences between the two hands were also examined.

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

Blinding was ensured by patients and rheumatologist were unaware the type of physiotherapy treatment application

入排标准

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

入选标准

  • diagnosed as Level 2-3 Rheumatoid Arthritis
  • no change in pharmacological treatment until 1 month before the study

排除标准

  • Presence of acute disease
  • Diagnosis of Level 4 Rheumatoid Arthritis
  • Intra-articular or intramuscular injection application in the previous months
  • Presence of hand-wrist surgery history in the last 6 months
  • Non-rheumatoid hand deformity

结局指标

主要结局

Subjective Pain Intensity

时间窗: 1 hour

The subjective pain intensity of the patients was assessed with the Visual Analogue Scale. The Visual Analog Scale includes scoring between 0 and 10. The corresponding numbers from 0 to 10 were explained to the patients. It was explained that the absence of pain was 0, the most severe pain felt was 10, and moderate pain was 5.

Range of Motion

时间窗: 1 hour

The range of motion of hand and metacarpophalangeal jonit were assessed using a goniometer

Hand muscle strength

时间窗: 1 hour

Hand grip strength was measured by dynamometer. The patient squeezed and released the dynamometer 3 times and the average of these three values was recorded.

Finger muscle strength

时间窗: 1 hour

Finger grip strength was measured by pinchmeter. The patient squeezed and released the dynamometer 3 times and the average of these three values was recorded.

Functional Assessment

时间窗: 1 hour

Grip Skill test will also be applied, and this test was basically developed for cases with RA. It has three main components; Filling the glass with water, holding socks, envelopes with paper clips. The maximum time allocated to each test is 60 seconds. The time to complete the first and second tests is multiplied by 1.8 and added to the other values. The total score range is 10-279. A high score means impaired hand function. The mean score value in healthy individuals is 16.5 (11-20).

次要结局

未报告次要终点

研究者

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

Ozge Baykan Copuroglu

Prelector/ Physiotherapist

Istanbul Arel University

研究点 (2)

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