NCT05515965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 24, 2022

Last Update Submit

August 24, 2022

Conditions

Keywords

Rheumatoid ArthritisKinesiotapeGrip StrengthHand functionHand deformity

Outcome Measures

Primary Outcomes (5)

  • 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

  • Range of Motion

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

    1 hour

  • 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

  • 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

  • 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

Study Arms (2)

Kinesiotape

EXPERIMENTAL

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

Other: Kinesiotaping

Control

SHAM COMPARATOR

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

Other: Sham

Interventions

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.

Kinesiotape
ShamOTHER

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.

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozge Baykan Copuroglu

Bahçelievler, Istanbul, 34194, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, RheumatoidHand Deformities

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ozge Baykan Copuroglu, MSc

    Istanbul Arel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Blinding was ensured by patients and rheumatologist were unaware the type of physiotherapy treatment application
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prelector/ Physiotherapist

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 25, 2022

Study Start

April 1, 2018

Primary Completion

October 1, 2018

Study Completion

October 15, 2018

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations