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Kinesiotaping Applied to the Thumb in Rheumatoid Hand

Primary Purpose

Rheumatoid Arthritis, Kinesiotape, Hand Deformity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotaping
Sham
Sponsored by
Istanbul Arel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Kinesiotape, Grip Strength, Hand function, Hand deformity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ozge Baykan Copuroglu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Kinesiotape

Control

Arm Description

The patients in the Kinesiotape group were taped with the mechanical correction method.

In the patients in the Control group were taped with tensionless gluing of the I tape.

Outcomes

Primary Outcome Measures

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.
Range of Motion
The range of motion of hand and metacarpophalangeal jonit were assessed using a goniometer
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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2022
Last Updated
August 24, 2022
Sponsor
Istanbul Arel University
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1. Study Identification

Unique Protocol Identification Number
NCT05515965
Brief Title
Kinesiotaping Applied to the Thumb in Rheumatoid Hand
Official Title
Acute Effect of Kinesiotaping Applied to the Thumb in Patients With Rheumatoid Hand
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Arel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Kinesiotape, Hand Deformity
Keywords
Rheumatoid Arthritis, Kinesiotape, Grip Strength, Hand function, Hand deformity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Blinding was ensured by patients and rheumatologist were unaware the type of physiotherapy treatment application
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotape
Arm Type
Experimental
Arm Description
The patients in the Kinesiotape group were taped with the mechanical correction method.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
In the patients in the Control group were taped with tensionless gluing of the I tape.
Intervention Type
Other
Intervention Name(s)
Kinesiotaping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective Pain Intensity
Description
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.
Time Frame
1 hour
Title
Range of Motion
Description
The range of motion of hand and metacarpophalangeal jonit were assessed using a goniometer
Time Frame
1 hour
Title
Functional Assessment
Description
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).
Time Frame
1 hour
Title
Hand muscle strength
Description
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.
Time Frame
1 hour
Title
Finger muscle strength
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozge Baykan Copuroglu, MSc
Organizational Affiliation
Istanbul Arel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ozge Baykan Copuroglu
City
Bahçelievler
State/Province
İstanbul
ZIP/Postal Code
34194
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Kinesiotaping Applied to the Thumb in Rheumatoid Hand

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