Wrist Morning StiffnessNCT02367157
Effectiveness of Kinesio Tape in Morning Stiffness and Functional Capacity in Patients With Rheumatoid Arthritis.
A study testing Kenzo Kase Method and Kinesio Taping in people with Wrist Morning Stiffness, run by CEU San Pablo University at 1 site in Spain.
Trial summary
The purpose of this study is to determine how the applications of Kinesio Tape affect the morning stiffness in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Wrist Morning Stiffness
- What is being tested?
- Kenzo Kase Method and Kinesio Taping
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2016to Jun 2017
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Rheumatoid Arthritis according to the criteria of the American Rheumatism Association with a minimum of 6 months evolution from diagnosis.
- These subjects must have morning stiffness daily in the wrist joint of a member or bilateral at least a month.
Who cannot join
- Subjects in postoperative affecting the mobility of joints to study phase.
- Subjects with sensory deficits or other inflammatory arthropathies.
- Subjects who are or come in a state of emergence of the hand or wrist joints during the investigation.
- Subjects who change their usual treatment (medication or other therapies) two months before the study or during the study.
- We exclude subjects who present some kind of allergy to Kinesio-Tape in which case it will be removed immediately.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine how the applications of Kinesio Tape affect the morning stiffness in patients with rheumatoid arthritis.
- Conditions
- Wrist Morning Stiffness
- Being tested
- Kenzo Kase Method, Kinesio Taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kenzo Kase MethodProcedure or surgery
Kinesio TapingDevice
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Kinesio taping | Experimental | Epicondilar and epitroclear muscle Kinesio Taping with a Space Correction on the wrist according Kenzo Kase Method Receives: Procedure: Kenzo Kase Method; Device: Kinesio Taping |
| No intervention: Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Wrist Morning Stiffness
Measured: participants will be followed for the duration in minutes of the morning stiffness, an expected average of 45 minutes]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startMar 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist Morning StiffnessStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367157
- Sponsor's protocol ID
- CEU-009
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2015
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kinesio Tape in Morning Stiffness and Functional Capacity in Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT02367157
- Acronym / sponsor ID
- CEU-009
- Conditions
- Wrist Morning Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Feb 2015 (estimated)
- 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.
The purpose of this study is to determine how the applications of Kinesio Tape affect the morning stiffness in patients with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Kinesio taping | Experimental | Procedure: Kenzo Kase Method, Device: Kinesio TapingEpicondilar and epitroclear muscle Kinesio Taping with a Space Correction on the wrist according Kenzo Kase Method |
| No intervention: Control | No intervention | – |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Rheumatoid Arthritis according to the criteria of the American Rheumatism Association with a minimum of 6 months evolution from diagnosis.
- These subjects must have morning stiffness daily in the wrist joint of a member or bilateral at least a month.
Key exclusion criteria (5 listed)
- Subjects in postoperative affecting the mobility of joints to study phase.
- Subjects with sensory deficits or other inflammatory arthropathies.
- Subjects who are or come in a state of emergence of the hand or wrist joints during the investigation.
- Subjects who change their usual treatment (medication or other therapies) two months before the study or during the study.
- We exclude subjects who present some kind of allergy to Kinesio-Tape in which case it will be removed immediately.
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 |
|---|---|---|
| Kenzo Kase Method | Procedure or surgery | Experimental: Kinesio taping |
| Kinesio Taping | Device | Experimental: Kinesio taping |
Primary outcome
Change in the Wrist Morning Stiffness
Time frame: participants will be followed for the duration in minutes of the morning stiffness, an expected average of 45 minutes]
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 21 Feb 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kenzo Kase Method and Kinesio Taping in people with Wrist Morning Stiffness, run by CEU San Pablo University at 1 site in Spain.
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 21 Feb 2021. 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 Spain. 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. 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?
Change in the Wrist Morning Stiffness (time frame: participants will be followed for the duration in minutes of the morning stiffness, an expected average of 45 minutes]). 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 21 Feb 2021.