Carpal Tunnel SyndromeNCT05475197
Evaluation of the Acute Effect of Kinesio Taping by Ultrasonography
A study testing Kinesio taping in people with Carpal Tunnel Syndrome, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The design of our study is a randomized, controlled, double-blind study. It is planned to be completed in twenty-four weeks with 34 participants. The main purpose of this study is to examine and compare the acute effects of two different kinesio tape applications on the carpal tunnel in patients with carpal tunnel… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Kinesio taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Feb 2023
- 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
- Patients with a diagnosis of moderate-mild carpal tunnel syndrome according to EMG findings
- Patients who read the informed consent form and volunteered to participate in the study
Who cannot join
- Patients with predisposing etiological factors (diabetes mellitus, acute trauma, rheumatological diseases, chronic kidney failure, pregnancy, hypothyroidism, hyperthyroidism, etc.) for carpal tunnel syndrome that may cause polyneuropathy.
- Patients receiving regular medical treatment such as continuous NSAIDs
- Patients who have received physical therapy or local steroid injection to the carpal tunnel region in the last 3 months
- Patients undergoing carpal tunnel surgery
- Patients with severe carpal tunnel syndrome
- Patients with a history of malignancy
- Patients with a history of cervical radiculopathy and ulnar neuropathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Department of Physical Medicine and Rehabilitation
Mersin, 33110
About this study
Official title: Evaluation of the Acute Effect of Kinesio Taping on Structures at the Wrist Level by Ultrasonography in Patients With Carpal Tunnel Syndrome
The design of our study is a randomized, controlled, double-blind study. It is planned to be completed in twenty-four weeks with 34 participants. The main purpose of this study is to examine and compare the acute effects of two different kinesio tape applications on the carpal tunnel in patients with carpal tunnel syndrome by ultrasonographic method.
Read the detailed description
Methodology of the Study:
This study will make on 15.09.2022 and within 15.01.2023 in the Department of Physical Medicine and Rehabilitation of Mersin University Faculty of Medicine Hospital. Patients who have been diagnosed with carpal tunnel syndrome and whose treatment is planned and who meet the inclusion and exclusion criteria will participate.
Anthropometric measurements:
On the day of arrival for the test, Dr. Figen Dağ (PhD, PT) will measure their height and weight and calculate their body mass index within the scope of anthropometric measurements. The height measurement will be measured by a height meter fixed to the wall. For this, volunteers will be asked to take off their shoes, stand upright and face the other side. BMI values will be calculated by dividing body weights by the square of height (kg/m2). With the bioelectric impedance method (Tanita BC-418 MA, Tanita Corporation, Tokyo, Japan), the body composition (lean body mass, fat mass, fat percentage, etc.) of all individuals will be determined. For this measurement, volunteers will be asked to take off their shoes and weigh in light clothes.
Kinesio taping applications:
Two different kinesio taping applications will be applied to the patients by Dr. Figen Dağ. For both groups, first of all, the skin will be thoroughly cleaned of oil and moisture by means of alcohol cotton. As a result of the randomization, the group in which the 34 people to be included in the study was made from the web site (www.randomizer.org) . Patients will be blinded to the kinesio taping methods they will receive.
Pain and Ultrasonographic Evaluation:
Just before the kinesio taping application and immediately after the kinesio taping application (after 48 hours) after the bands are removed, the pressure pain assessment and the condition of the structures at the wrist level are blinded to the taping applications. It will be evaluated by Dr. Orhan GÜVENER (MD) by ultrasonography (US).
Pressure pain assessment will be carried out through a carpal tunnel with a mechanical algometer (J Tech Medical, Salt Lake City, UT, USA).
US measurements are carried out bidirectionally with linear probes (5-13 MHz Logiq P5; GE Medical Systems). Carpal tunnel evaluations will be performed while patients are seated with their hands in a neutral position. By avoiding compression of the probe on the tissue by using abundant gel, skin-subcutaneous tissue thickness, vertical, horizontal axle length and diameter of the median nerve, carpal ligament thickness, distance of carpal ligament and median nerve to the skin will be measured from proximal and distal carpal tunnel levels.
Presentation of Results and Statistical Methods to be used in the Study:
Statistical analyses will be made in a computer environment. The suitability of the variables to the normal distribution will be examined using visual (histogram and probability graphs) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Demographic data, the results of the parameters to be evaluated will be evaluated by descriptive analyzes and will be given as mean (Average) ±standard deviation (SD), median, and/or interval. In the evaluation of intra-group differences, the paired-t-test will be used if the data show the normal distribution and Wilcoxon tests will be used if they do not show normal distribution. The differences between the groups will be determined by the independent t-test if the normal distribution of the data stops and by the Mann-Whitney U test if the normal distribution is not stopped. The relationships between the parameters will be examined using the Pearson test. For statistical analyses, the significance level will be considered to be 0.05.
Intergroup, 1st, and 2nd According to Cohen, at least 34 people were planned to be enrolled in the study to determine the significant difference between the measurements with 80% power and 5% type I error at 0.5 (moderate) effect size. The calculation was done in G*Power 3.1.9.4.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Kinesio taping
- Keywords
- Carpal Tunnel Syndrome,, Ultrasound, Kinesio 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.
Kinesio tapingDevice
We planned to perform two different taping applications to evaluate the acute effect of kinesio taping application on the carpal tunnels of individuals with carpal tunnel syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping Type 1 | Experimental | For the first group; While the wrist is 30° extension, the forearm is supinated and the elbow is extended, the distance between the 1st metacarpal joint and the medial epicondyles of the patient up to 5 cm below the median epicondyle will be measured. Two strips with width of 2.5 cm will be prepared. For the median nerve, the first band will be adhered along the nerve trachea by stretching of moderate intensity (50%) from the 2nd and 3rd metacarpophalangeal joint to 5 cm below the medial epicondyle.
The second strip will be applied without stretching to a distance of 5 cm under the medial epicondyle from the 4th and 5th metacarpophalangeal joint. In addition, a strip half the length of the wrist circumference will be adhered to the volar face of the wrist by applying tension to the middle 1/3 of it, without applying tension to both ends. Receives: Device: Kinesio taping |
| Kinesio taping Type 2 | Experimental | For the second group; While the elbow is in full extension and the wrist in the extension and supination position, the distal two free ends of the tape will be adhered to the thenar and hypothenar regions without stretching. The middle 1/3 of the X-shaped tape will be adhered to the forearm volar face by applying moderate stretching.The first half of the two proximal free ends will have adhered to the medial and lateral epicondyle with little or no stretching, and the last half without any stretching.
The I-shaped tape will be adhered to the radial region of the wrist with the elbow in full extension, the wrist in a neutral position, and the palm closed. The middle of the tape will be stretched lightly and moderately, and the last 1/3 of it will be adhered to the ulnar part of the wrist without stretching. Kinesio taping will be applied to both groups once. Receives: Device: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline ultrasonographic measurements
Ultrasonographic measurements will be made using linear probes (5-13 MHz Logiq P5; GE Medical Systems). Carpal tunnel assessments will be performed while the patients are sitting with their hands in a neutral position. By avoiding compression of the probe on the tissue by using plenty of gel, skin-subcutaneous tissue thickness, vertical and horizontal axis length and diameter of the median nerve, carpal ligament thickness, carpal ligament and median nerve distances to the skin will have measured. It will have measured in proximal and distal carpal tunnel levels.
Measured: Just before Kinesio Taping application
After the application of ultrasonographic measurements
Ultrasonographic measurements will be made using linear probes (5-13 MHz Logiq P5; GE Medical Systems). Carpal tunnel assessments will be performed while the patients are sitting with their hands in a neutral position. By avoiding compression of the probe on the tissue by using plenty of gel, skin-subcutaneous tissue thickness, vertical and horizontal axis length and diameter of the median nerve, carpal ligament thickness, carpal ligament and median nerve distances to the skin will be measured from the proximal and distal carpal tunnel levels.
Measured: Immediately after the tapes are removed after the Kinesio Taping application (48 hours later)
Baseline pain pressure threshold
Pain pressure threshold will be assessed through the carpal tunnel with a mechanical algometer (J Tech Medical, Salt Lake City, UT, USA).Assessments will be performed while the patients are sitting with their hands in a neutral position.
Measured: Just before Kinesio Taping application
After the application of pain pressure threshold
Pain pressure threshold will be assessed through the carpal tunnel with a mechanical algometer (J Tech Medical, Salt Lake City, UT, USA).Assessments will be performed while the patients are sitting with their hands in a neutral position.
Measured: Immediately after the tapes are removed after the Kinesio Taping application (48 hours later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start15 Nov 2022
- Primary completion15 Jan 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orhan Güvener, Mersin University
- Investigators
- Orhan Güvener, MD, Principal investigator, Mersin University Medical SchoolFigen Dağ, PhD, Study chair, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475197
- Sponsor's protocol ID
- MEUTF-FTR-GUVENER-001
- Status last verified
- Jun 2023
- First submitted
- 22 Jul 2022
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guvener O, Dag F, Sahin G, Ozcakar L. Immediate effects of Kinesio taping in carpal tunnel syndrome: A randomized controlled double-blind ultrasonographic study. J Hand Ther. 2024 Oct-Dec;37(4):520-528. doi: 10.1016/j.jht.2023.12.017. Epub 2024 Feb 15.
PubMed 38360485
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acute Effect of Kinesio Taping on Structures at the Wrist Level by Ultrasonography in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05475197
- Acronym / sponsor ID
- MEUTF-FTR-GUVENER-001
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome,, Ultrasound, Kinesio taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 26 Jul 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.
The design of our study is a randomized, controlled, double-blind study. It is planned to be completed in twenty-four weeks with 34 participants. The main purpose of this study is to examine and compare the acute effects of two different kinesio tape applications on the carpal tunnel in patients with carpal tunnel syndrome by ultrasonographic method.
Detailed description
Methodology of the Study:
This study will make on 15.09.2022 and within 15.01.2023 in the Department of Physical Medicine and Rehabilitation of Mersin University Faculty of Medicine Hospital. Patients who have been diagnosed with carpal tunnel syndrome and whose treatment is planned and who meet the inclusion and exclusion criteria will participate.
Anthropometric measurements:
On the day of arrival for the test, Dr. Figen Dağ (PhD, PT) will measure their height and weight and calculate their body mass index within the scope of anthropometric measurements. The height measurement will be measured by a height meter fixed to the wall. For this, volunteers will be asked to take off their shoes, stand upright and face the other side. BMI values will be calculated by dividing body weights by the square of height (kg/m2). With the bioelectric impedance method (Tanita BC-418 MA, Tanita Corporation, Tokyo, Japan), the body composition (lean body mass, fat mass, fat percentage, etc.) of all individuals will be determined. For this measurement, volunteers will be asked to take off their shoes and weigh in light clothes.
Kinesio taping applications:
Two different kinesio taping applications will be applied to the patients by Dr. Figen Dağ. For both groups, first of all, the skin will be thoroughly cleaned of oil and moisture by means of alcohol cotton. As a result of the randomization, the group in which the 34 people to be included in the study was made from the web site (www.randomizer.org) . Patients will be blinded to the kinesio taping methods they will receive.
Pain and Ultrasonographic Evaluation:
Just before the kinesio taping application and immediately after the kinesio taping application (after 48 hours) after the bands are removed, the pressure pain assessment and the condition of the structures at the wrist level are blinded to the taping applications. It will be evaluated by Dr. Orhan GÜVENER (MD) by ultrasonography (US).
Pressure pain assessment will be carried out through a carpal tunnel with a mechanical algometer (J Tech Medical, Salt Lake City, UT, USA).
US measurements are carried out bidirectionally with linear probes (5-13 MHz Logiq P5; GE Medical Systems). Carpal tunnel evaluations will be performed while patients are seated with their hands in a neutral position. By avoiding compression of the probe on the tissue by using abundant gel, skin-subcutaneous tissue thickness, vertical, horizontal axle length and diameter of the median nerve, carpal ligament thickness, distance of carpal ligament and median nerve to the skin will be measured from proximal and distal carpal tunnel levels.
Presentation of Results and Statistical Methods to be used in the Study:
Statistical analyses will be made in a computer environment. The suitability of the variables to the normal distribution will be examined using visual (histogram and probability graphs) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Demographic data, the results of the parameters to be evaluated will be evaluated by descriptive analyzes and will be given as mean (Average) ±standard deviation (SD), median, and/or interval. In the evaluation of intra-group differences, the paired-t-test will be used if the data show the normal distribution and Wilcoxon tests will be used if they do not show normal distribution. The differences between the groups will be determined by the independent t-test if the normal distribution of the data stops and by the Mann-Whitney U test if the normal distribution is not stopped. The relationships between the parameters will be examined using the Pearson test. For statistical analyses, the significance level will be considered to be 0.05.
Intergroup, 1st, and 2nd According to Cohen, at least 34 people were planned to be enrolled in the study to determine the significant difference between the measurements with 80% power and 5% type I error at 0.5 (moderate) effect size. The calculation was done in G*Power 3.1.9.4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping Type 1 | Experimental | Device: Kinesio tapingFor the first group; While the wrist is 30° extension, the forearm is supinated and the elbow is extended, the distance between the 1st metacarpal joint and the medial epicondyles of the patient up to 5 cm below the median epicondyle will be measured. Two strips with width of 2.5 cm will be prepared. For the median nerve, the first band will be adhered along the nerve trachea by stretching of moderate intensity (50%) from the 2nd and 3rd metacarpophalangeal joint to 5 cm below the medial epicondyle. The second strip will be applied without stretching to a distance of 5 cm under the medial epicondyle from the 4th and 5th metacarpophalangeal joint. In addition, a strip half the length of the wrist circumference will be adhered to the volar face of the wrist by applying tension to the middle 1/3 of it, without applying tension to both ends. |
| Kinesio taping Type 2 | Experimental | Device: Kinesio tapingFor the second group; While the elbow is in full extension and the wrist in the extension and supination position, the distal two free ends of the tape will be adhered to the thenar and hypothenar regions without stretching. The middle 1/3 of the X-shaped tape will be adhered to the forearm volar face by applying moderate stretching.The first half of the two proximal free ends will have adhered to the medial and lateral epicondyle with little or no stretching, and the last half without any stretching. The I-shaped tape will be adhered to the radial region of the wrist with the elbow in full extension, the wrist in a neutral position, and the palm closed. The middle of the tape will be stretched lightly and moderately, and the last 1/3 of it will be adhered to the ulnar part of the wrist without stretching. Kinesio taping will be applied to both groups once. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a diagnosis of moderate-mild carpal tunnel syndrome according to EMG findings
- Patients who read the informed consent form and volunteered to participate in the study
Key exclusion criteria (7 listed)
- Patients with predisposing etiological factors (diabetes mellitus, acute trauma, rheumatological diseases, chronic kidney failure, pregnancy, hypothyroidism, hyperthyroidism, etc.) for carpal tunnel syndrome that may cause polyneuropathy.
- Patients receiving regular medical treatment such as continuous NSAIDs
- Patients who have received physical therapy or local steroid injection to the carpal tunnel region in the last 3 months
- Patients undergoing carpal tunnel surgery
- Patients with severe carpal tunnel 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 |
|---|---|---|
| Kinesio tapingWe planned to perform two different taping applications to evaluate the acute effect of kinesio taping application on the carpal tunnels of individuals with carpal tunnel syndrome. | Device | Kinesio taping Type 1, Kinesio taping Type 2 |
Primary outcome
Baseline ultrasonographic measurements
Time frame: Just before Kinesio Taping application
Ultrasonographic measurements will be made using linear probes (5-13 MHz Logiq P5; GE Medical Systems). Carpal tunnel assessments will be performed while the patients are sitting with their hands in a neutral position. By avoiding compression of the probe on the tissue by using plenty of gel, skin-subcutaneous tissue thickness, vertical and horizontal axis length and diameter of the median nerve, carpal ligament thickness, carpal ligament and median nerve distances to the skin will have measured. It will have measured in proximal and distal carpal tunnel levels.
After the application of ultrasonographic measurements
Time frame: Immediately after the tapes are removed after the Kinesio Taping application (48 hours later)
Ultrasonographic measurements will be made using linear probes (5-13 MHz Logiq P5; GE Medical Systems). Carpal tunnel assessments will be performed while the patients are sitting with their hands in a neutral position. By avoiding compression of the probe on the tissue by using plenty of gel, skin-subcutaneous tissue thickness, vertical and horizontal axis length and diameter of the median nerve, carpal ligament thickness, carpal ligament and median nerve distances to the skin will be measured from the proximal and distal carpal tunnel levels.
Baseline pain pressure threshold
Time frame: Just before Kinesio Taping application
Pain pressure threshold will be assessed through the carpal tunnel with a mechanical algometer (J Tech Medical, Salt Lake City, UT, USA).Assessments will be performed while the patients are sitting with their hands in a neutral position.
After the application of pain pressure threshold
Time frame: Immediately after the tapes are removed after the Kinesio Taping application (48 hours later)
Pain pressure threshold will be assessed through the carpal tunnel with a mechanical algometer (J Tech Medical, Salt Lake City, UT, USA).Assessments will be performed while the patients are sitting with their hands in a neutral position.
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 2 Jun 2023.
- Derived from this study: PubMed 38360485Guvener O, Dag F, Sahin G, Ozcakar L. Immediate effects of Kinesio taping in carpal tunnel syndrome: A randomized controlled double-blind ultrasonographic study. J Hand Ther. 2024 Oct-Dec;37(4):520-528. doi: 10.1016/j.jht.2023.12.017. Epub 2024 Feb 15.
- Individual participant dataSharing planned: No
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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.
Orhan Güvener, MD principal investigator
Mersin University Medical School
Figen Dağ, PhD study chair
Mersin 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 Kinesio taping in people with Carpal Tunnel Syndrome, run by Mersin 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 2 Jun 2023. 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. 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?
Baseline ultrasonographic measurements (time frame: Just before Kinesio Taping application). The study lists 4 primary outcomes in all. 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 NCT05475197, which also lists 1 linked publication.
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 2 Jun 2023.