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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05515965
Other study ID # RomatolojiParmak
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date October 15, 2018

Study information

Verified date August 2022
Source Istanbul Arel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date October 15, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - diagnosed as Level 2-3 Rheumatoid Arthritis - no change in pharmacological treatment until 1 month before the study Exclusion Criteria: - 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

Study Design


Intervention

Other:
Kinesiotaping
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. The application was performed with the patient in a sitting position with his arm supported by a pillow from the elbow. Evaluation parameters were evaluated before and 1 hour after the application, and the acute effect was examined. Both the dominant and nondominant hands of the patients were taped and the differences between the two hands were also examined.
Sham
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. Evaluation parameters were evaluated before and 1 hour after the application, and the acute effect was examined. Both the dominant and nondominant hands of the patients were taped and the differences between the two hands were also examined.

Locations

Country Name City State
Turkey Ozge Baykan Copuroglu Bahçelievler Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Arel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective Pain Intensity 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. 1 hour
Primary Range of Motion The range of motion of hand and metacarpophalangeal jonit were assessed using a goniometer 1 hour
Primary Functional Assessment 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). 1 hour
Primary Hand muscle strength 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. 1 hour
Primary Finger muscle strength 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. 1 hour
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