Evaluation of the Acute Effect of Kinesio Taping by Ultrasonography

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: Kinesio taping

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Mersin, Turkey, 33110
    • Mersin University Department of Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesio taping Type 1; 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.	Device: Kinesio taping; 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.
Experimental: Kinesio taping Type 2; 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.	Device: Kinesio taping; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Immediately after the tapes are removed after the Kinesio Taping application (48 hours later)

Collaborators and Investigators

• Sponsor: Mersin University
• Investigators: Principal Investigator: Orhan Güvener, MD, Mersin University Medical School; Study Chair: Figen Dağ, PhD, Mersin University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Kinesio taping; Carpal Tunnel Syndrome,
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: MEUTF-FTR-GUVENER-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No