Clinical trial NCT05475197: Evaluation of the Acute Effect of Kinesio Taping by Ultrasonography
Official title: Evaluation of the Acute Effect of Kinesio Taping on Structures at the Wrist Level by Ultrasonography in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome,
Ultrasound
Kinesio taping
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Baseline ultrasonographic measurements
timeFrame: Just before Kinesio Taping application
measure: After the application of ultrasonographic measurements
timeFrame: Immediately after the tapes are removed after the Kinesio Taping application (48 hours later)
measure: Baseline pain pressure threshold
timeFrame: Just before Kinesio Taping application
measure: After the application of pain pressure threshold
timeFrame: Immediately after the tapes are removed after the Kinesio Taping application (48 hours later)
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Mersin University Medical School
name: Orhan Güvener, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Figen Dağ, PhD
role: STUDY_CHAIR
References: