Carpal Tunnel Syndrome (CTS)NCT06710041
Kinesiotaping in Carpal Tunnel Syndrome
A study testing Kinesiotape and Exercise in people with Carpal Tunnel Syndrome (CTS), run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Objective: Kinesiotaping (KT) is a relatively new technique, which reduces the pressure on the median nerve by extending the transverse carpal ligament. The aim of this study was to evaluate the effectiveness of KT on Carpal tunnel syndrome (CTS) in a randomized, placebo-controlled manner. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Kinesiotape and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 28 Feb 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clicical diagnosis of mild and moderate CTS
- having the CTS symptoms for at least 6 weeks
Who cannot join
- electrophysiological diagnosis of severe CTS,
- thenar atrophy,
- local corticosteroid injection or KT application or physical therapy treatment for CTS within the last 3 months,
- patients with secondary metabolic causes for CTS (such as diabetes mellitus, pregnancy, rheumatoid arthritis, sarcoidosis, thyroid disease),
- patients with other conditions that may cause neck and arm pain (cervical disc hernia, arthritis, epicondylitis, rotator cuff syndrome),
- a history of fracture in the wrist,
- previous CTS surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Kinesiotaping in Carpal Tunnel Syndrome Treatment: a Randomized Controlled Trial
Objective: Kinesiotaping (KT) is a relatively new technique, which reduces the pressure on the median nerve by extending the transverse carpal ligament. The aim of this study was to evaluate the effectiveness of KT on Carpal tunnel syndrome (CTS) in a randomized, placebo-controlled manner.
Methods: Patients were randomly divided into three groups: Group 1 (KT plus tendon and nerve gliding exercises), Group 2 (sham-taping plus exercises) and Group 3 (exercises alone, control group). KT was applied 3 times with 5-day intervals throughout the study, with "neural technique" for median and ulnar nerves and "area correction technique" for carpal tunnel releasing. In the placebo group kinesiotapes were applied without stretching and proper position. Hand grip strength, VAS, Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), and Short Form-12 (SF-12) were measured as outcome parameters at the first visit, 3rd and 6th week.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Kinesiotape, Exercise, sham taping
- Keywords
- carpal tunnel syndrome, Kinesiotaping, Sham taping
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapeDevice
Kinesiotape, when applied with a specific method and tension, significantly reduces the pressure on the median nerve by extending the transverse carpal ligament. It regulates edema under the skin and improves lymphatic and blood circulation. It reduces muscle spasms, eases the movement of tendons and fascia, and reduces pain through neurological suppression
ExerciseOther
Tendon and nerve gliding exercise
sham tapingDevice
In the sham taping group, kinesiotape was applied with two I bands without stretching and without having the proper position. This group was considered as the placebo group.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping plus tendon and nerve gliding exercises | Active comparator | Kinesiotaping was applied 3 times with 5-day intervals Receives: Device: Kinesiotape; Other: Exercise |
| Sham taping plus tendon and nerve gliding exercises | Sham comparator | Sham taping was applied 3 times with 5-day intervals without stretching and without having the proper position. Receives: Other: Exercise; Device: sham taping |
| tendon and nerve gliding exercises alone | Other | The control group received exercise therapy only Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level
pain level was assessed using visual analog scale.The minimum and maximum values were 0 and 10, and higher scores mean a better outcome.
Measured: From enrollment to the end of treatment at 3 weeks
Secondary outcomes (1)
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
The BCTQ is a disease specific questionnaire to evaluate the symptom severity and functional capacity. High scores indicate increased symtom severity and low functional capacity
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Jul 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanife BAYKAL ŞAHİN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710041
- Sponsor's protocol ID
- 2020/38
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Geler Kulcu D, Bursali C, Aktas I, Bozkurt Alp S, Unlu Ozkan F, Akpinar P. Kinesiotaping as an alternative treatment method for carpal tunnel syndrome. Turk J Med Sci. 2016 Jun 23;46(4):1042-9. doi: 10.3906/sag-1503-4.
PubMed 27513402Giray E, Karali-Bingul D, Akyuz G. The Effectiveness of Kinesiotaping, Sham Taping or Exercises Only in Lateral Epicondylitis Treatment: A Randomized Controlled Study. PM R. 2019 Jul;11(7):681-693. doi: 10.1002/pmrj.12067. Epub 2019 Mar 28.
PubMed 30609278
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesiotaping in Carpal Tunnel Syndrome Treatment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06710041
- Acronym / sponsor ID
- 2020/38
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- carpal tunnel syndrome, Kinesiotaping, Sham taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 29 Nov 2024 (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: Kinesiotaping (KT) is a relatively new technique, which reduces the pressure on the median nerve by extending the transverse carpal ligament. The aim of this study was to evaluate the effectiveness of KT on Carpal tunnel syndrome (CTS) in a randomized, placebo-controlled manner.
Methods: Patients were randomly divided into three groups: Group 1 (KT plus tendon and nerve gliding exercises), Group 2 (sham-taping plus exercises) and Group 3 (exercises alone, control group). KT was applied 3 times with 5-day intervals throughout the study, with "neural technique" for median and ulnar nerves and "area correction technique" for carpal tunnel releasing. In the placebo group kinesiotapes were applied without stretching and proper position. Hand grip strength, VAS, Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), and Short Form-12 (SF-12) were measured as outcome parameters at the first visit, 3rd and 6th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping plus tendon and nerve gliding exercises | Active comparator | Device: Kinesiotape, Other: ExerciseKinesiotaping was applied 3 times with 5-day intervals |
| Sham taping plus tendon and nerve gliding exercises | Sham comparator | Other: Exercise, Device: sham tapingSham taping was applied 3 times with 5-day intervals without stretching and without having the proper position. |
| tendon and nerve gliding exercises alone | Other | Other: ExerciseThe control group received exercise therapy only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clicical diagnosis of mild and moderate CTS
- having the CTS symptoms for at least 6 weeks
Key exclusion criteria (7 listed)
- electrophysiological diagnosis of severe CTS,
- thenar atrophy,
- local corticosteroid injection or KT application or physical therapy treatment for CTS within the last 3 months,
- patients with secondary metabolic causes for CTS (such as diabetes mellitus, pregnancy, rheumatoid arthritis, sarcoidosis, thyroid disease),
- patients with other conditions that may cause neck and arm pain (cervical disc hernia, arthritis, epicondylitis, rotator cuff syndrome),
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 |
|---|---|---|
| KinesiotapeKinesiotape, when applied with a specific method and tension, significantly reduces the pressure on the median nerve by extending the transverse carpal ligament. It regulates edema under the skin and improves lymphatic and blood circulation. It reduces muscle spasms, eases the movement of tendons and fascia, and reduces pain through neurological suppression | Device | Kinesiotaping plus tendon and nerve gliding exercises |
| ExerciseTendon and nerve gliding exercise | Other | Kinesiotaping plus tendon and nerve gliding exercises, Sham taping plus tendon and nerve gliding exercises, tendon and nerve gliding exercises alone |
| sham tapingIn the sham taping group, kinesiotape was applied with two I bands without stretching and without having the proper position. This group was considered as the placebo group. | Device | Sham taping plus tendon and nerve gliding exercises |
Primary outcome
pain level
Time frame: From enrollment to the end of treatment at 3 weeks
pain level was assessed using visual analog scale.The minimum and maximum values were 0 and 10, and higher scores mean a better outcome.
1 secondary outcome
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Time frame: From enrollment to the end of treatment at 6 weeks
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 29 Nov 2024.
- Background: PubMed 27513402Geler Kulcu D, Bursali C, Aktas I, Bozkurt Alp S, Unlu Ozkan F, Akpinar P. Kinesiotaping as an alternative treatment method for carpal tunnel syndrome. Turk J Med Sci. 2016 Jun 23;46(4):1042-9. doi: 10.3906/sag-1503-4.
- Background: PubMed 30609278Giray E, Karali-Bingul D, Akyuz G. The Effectiveness of Kinesiotaping, Sham Taping or Exercises Only in Lateral Epicondylitis Treatment: A Randomized Controlled Study. PM R. 2019 Jul;11(7):681-693. doi: 10.1002/pmrj.12067. Epub 2019 Mar 28.
- Individual participant dataSharing planned: Yes
Related trials for Carpal Tunnel Syndrome (CTS)
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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 Kinesiotape and Exercise in people with Carpal Tunnel Syndrome (CTS), run by Karadeniz Technical 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 7 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 29 Nov 2024. 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?
pain level (time frame: From enrollment to the end of treatment at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06710041, which also lists 2 linked publications.
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 29 Nov 2024.