Rheumatoid ArthritisNCT05515965
Kinesiotaping Applied to the Thumb in Rheumatoid Hand
A study testing Kinesiotaping in people with Rheumatoid Arthritis and Kinesiotape, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis, Kinesiotape, Hand Deformity
- What is being tested?
- Kinesiotaping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 15 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed as Level 2-3 Rheumatoid Arthritis
- no change in pharmacological treatment until 1 month before the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ozge Baykan Copuroglu
Bahçelievler, Istanbul, 34194
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Kinesiotape, Hand Deformity
- Being tested
- Kinesiotaping, Sham
- Keywords
- Rheumatoid Arthritis, Kinesiotape, Grip Strength, Hand function, Hand deformity
- Medical subject headings
- Arthritis, Rheumatoid, Hand Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape | Experimental | The patients in the Kinesiotape group were taped with the mechanical correction method. Receives: Other: Kinesiotaping |
| Control | Sham comparator | In the patients in the Control group were taped with tensionless gluing of the I tape. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Range of Motion
The range of motion of hand and metacarpophalangeal jonit were assessed using a goniometer
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Apr 2018
- Primary completion1 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Baykan Copuroglu, Istanbul Arel University
- Investigators
- Ozge Baykan Copuroglu, MSc, Principal investigator, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515965
- Sponsor's protocol ID
- RomatolojiParmak
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Kinesiotaping Applied to the Thumb in Patients With Rheumatoid Hand
- ClinicalTrials.gov ID
- NCT05515965
- Acronym / sponsor ID
- RomatolojiParmak
- Conditions
- Rheumatoid Arthritis, Kinesiotape, Hand Deformity
- Keywords
- Rheumatoid Arthritis, Kinesiotape, Grip Strength, Hand function, Hand deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape | Experimental | Other: KinesiotapingThe patients in the Kinesiotape group were taped with the mechanical correction method. |
| Control | Sham comparator | Other: ShamIn the patients in the Control group were taped with tensionless gluing of the I tape. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- diagnosed as Level 2-3 Rheumatoid Arthritis
- no change in pharmacological treatment until 1 month before the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinesiotapingThe 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. | Other | Kinesiotape |
| ShamSham 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. | Other | Control |
Primary outcome
Subjective Pain Intensity
Time frame: 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
Time frame: 1 hour
The range of motion of hand and metacarpophalangeal jonit were assessed using a goniometer
Functional Assessment
Time frame: 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).
Hand muscle strength
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozge Baykan Copuroglu, MSc principal investigator
Istanbul Arel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping in people with Rheumatoid Arthritis and Kinesiotape, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Pain Intensity (time frame: 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.