- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05515965
Kinesiotaping Applied to the Thumb in Rheumatoid Hand
Acute Effect of Kinesiotaping Applied to the Thumb in Patients With Rheumatoid Hand
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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İstanbul
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Bahçelievler, İstanbul, Turkey, 34194
- Ozge Baykan Copuroglu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Kinesiotape
The patients in the Kinesiotape group were taped with the mechanical correction method.
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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.
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Sham Comparator: Control
In the patients in the Control group were taped with tensionless gluing of the I tape.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Subjective Pain Intensity
Time Frame: 1 hour
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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.
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1 hour
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Range of Motion
Time Frame: 1 hour
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The range of motion of hand and metacarpophalangeal jonit were assessed using a goniometer
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1 hour
|
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Functional Assessment
Time Frame: 1 hour
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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).
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1 hour
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Hand muscle strength
Time Frame: 1 hour
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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.
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1 hour
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Finger muscle strength
Time Frame: 1 hour
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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.
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1 hour
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RomatolojiParmak
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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