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Effect of the Kinesiotaping on paın, Function and electrophysiologıcal Findings in Patient With Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
I tape technique
Button hole technique
exercises
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring kinesiotaping, electrophysiological findings, carpal tunel syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female and male patients aged 18-65 years who applied to Ahi Evran University Physical Medicine and Rehabilitation Outpatient Clinic and diagnosed with mild to moderate carpal tunnel syndrome by clinical and EMG
  2. Patients who can correctly understand what is stated in the patient information form and have cooperation
  3. Patients who consented to participate in the study according to the informed consent form

Exclusion Criteria:

  1. Cervical radiculopathy
  2. Polyneuropathy
  3. Brachial plexopathy
  4. Systemic corticosteroid use
  5. History of fracture and trauma in the treated side forearm and wrist
  6. Inflammatory rheumatic disease
  7. Pregnant and lactating patients
  8. Systemic diseases such as renal insufficiency, peptic ulcer, DM, hypothyroidism, coagulation disorder
  9. Patients undergoing carpal tunnel syndrome surgery
  10. Thoracic outlet syndrome
  11. Thenar atrophy, severe carpal tunnel syndrome
  12. The patient is reluctant or states that he cannot participate for any reason.

Sites / Locations

  • Ahi Evran University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

I tape technique

Button hole technique

exercises

Arm Description

I tape technique described by Dr Kenzo Kase will be applied once a week, a total of 3 times, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day.

Button hole technique defined by Dr Kenzo Kase will be applied once a week, 3 times in total, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day.

exercises will be taught to the patient and a total of 21 sessions will be applied once a day.

Outcomes

Primary Outcome Measures

Visual Analog Scale
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Visual Analog Scale
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Visual Analog Scale
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Hand grip strength
Jamar dynamometer will be used to measure hand grip strength. Jamar dynamometer measures static grip strength in pounds and kilograms. Measurements will be made with the patient in a sitting position, arm adducted, elbow flexed to 90 degrees, forearm in neutral position, as recommended by the American Association of Hand Therapists. Patients are asked to squeeze the dynamometer for at least 3 seconds with maximum contraction. 3 measurements are made with a 1 minute break between measurements. The average of 3 measurements is recorded in kilograms
hand grip strength
Jamar dynamometer will be used to measure hand grip strength. Jamar dynamometer measures static grip strength in pounds and kilograms. Measurements will be made with the patient in a sitting position, arm adducted, elbow flexed to 90 degrees, forearm in neutral position, as recommended by the American Association of Hand Therapists. Patients are asked to squeeze the dynamometer for at least 3 seconds with maximum contraction. 3 measurements are made with a 1 minute break between measurements. The average of 3 measurements is recorded in kilograms
hand grip strength
Jamar dynamometer will be used to measure hand grip strength. Jamar dynamometer measures static grip strength in pounds and kilograms. Measurements will be made with the patient in a sitting position, arm adducted, elbow flexed to 90 degrees, forearm in neutral position, as recommended by the American Association of Hand Therapists. Patients are asked to squeeze the dynamometer for at least 3 seconds with maximum contraction. 3 measurements are made with a 1 minute break between measurements. The average of 3 measurements is recorded in kilograms
electrophysiologıcal Findings
Median sensory nerve action potential amplitude, Compound muscle action potential amplitude, Median sensory distal latency, Median motor distal latency, Median sensory nerve conduction velocity, was evaluated by EMG.
electrophysiologıcal Findings
Median sensory nerve action potential amplitude, Compound muscle action potential amplitude, Median sensory distal latency, Median motor distal latency, Median sensory nerve conduction velocity, was evaluated by EMG.
electrophysiologıcal Findings
Median sensory nerve action potential amplitude, Compound muscle action potential amplitude, Median sensory distal latency, Median motor distal latency, Median sensory nerve conduction velocity, was evaluated by EMG.

Secondary Outcome Measures

function
The Boston carpal tunnel questionnaire (BCTA) has been proposed for clinical standardization of CTS patients. It consists of nineteen questions and the answers are evaluated with a minimum of one and a maximum of five points. A high mean score indicates that the patient's complaints are severe or that their functional capacity is insufficient. The symptom severity score is the average of the eleven questions and the functional capacity score of the eight questions.
function
The Boston carpal tunnel questionnaire (BCTA) has been proposed for clinical standardization of CTS patients. It consists of nineteen questions and the answers are evaluated with a minimum of one and a maximum of five points. A high mean score indicates that the patient's complaints are severe or that their functional capacity is insufficient. The symptom severity score is the average of the eleven questions and the functional capacity score of the eight questions.
function
The Boston carpal tunnel questionnaire (BCTA) has been proposed for clinical standardization of CTS patients. It consists of nineteen questions and the answers are evaluated with a minimum of one and a maximum of five points. A high mean score indicates that the patient's complaints are severe or that their functional capacity is insufficient. The symptom severity score is the average of the eleven questions and the functional capacity score of the eight questions.

Full Information

First Posted
October 14, 2022
Last Updated
August 1, 2023
Sponsor
Kirsehir Ahi Evran Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05592067
Brief Title
Effect of the Kinesiotaping on paın, Function and electrophysiologıcal Findings in Patient With Carpal Tunnel Syndrome
Official Title
Effect of the Kinesiotaping on paın, Function and electrophysiologıcal Findings in Patient With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the effectiveness of different kinesio taping techniques applied in carpal tunnel syndrome on pain, mobility, functional status and electrophysiological results and to investigate whether they are superior to the control group.
Detailed Description
Carpal tunnel syndrome (CTS) was first described by Paget in 1854, and detailed information about its clinical course and surgical techniques were made by Phalen. Carpal tunnel syndrome (CTS) is a clinical picture consisting of symptoms resulting from compression of the median nerve in the carpal tunnel at the wrist level and is the most common entrapment neuropathy. Although it is due to idiopathic and secondary causes, the pathophysiology of CTS is not fully understood. It is 3 times more common in women than in men. The fact that CTS occurs more frequently in the dominant hand supports the important role of hand activity in the emergence of the disease. Since the sensory branches of the median nerve innervate the first three fingers and half of the fourth finger, they typically complain of burning, pinprick, tingling and numbness in these fingers in CTS. In some cases, the pain may not match the normal sensory area of the median nerve in the hand. The diagnosis of CTS is easily made by history and physical examination. Imaging and electrodiagnostic studies are helpful in confirming the diagnosis. Treatment varies according to the degree of CTS. Different conservative treatment methods are used in the treatment of mild and moderate CTS. The most commonly used methods are splint, local corticosteroid injection (LCE), nonsteroidal anti-inflammatory drugs (NSAID) and conventional treatment agents (TENS, hotpack, ultrasound). Treatment modalities for edema and pain should not be ignored during the rehabilitation period. In this respect, kinesiotaping (KT) treatment, which is practical, comfortable and safe for the patient, is one of the complementary treatment modalities with positive clinical results.The purpose of the kinesiological taping (KB) method, developed by Kenzo Kase in the 1970s, is to support the muscle structures and increase their stability without limiting the range of motion of the joint. KB application is used with many indications such as pain, posture disorders, tendinitis bursitis, foot deformities, sports injuries, lymphedema and entrapment neuropathies. Research on the use of kinesiotaping in the conservative treatment of carpal tunnel syndrome has increased in recent years. The data of our study will contribute to the literature in order to develop the right technique for kinesiotaping in the treatment of CTS. The estimated number of volunteers expected to participate in the study was determined according to power analysis. The sample size of the study was determined by the GPower 3.1.9.6 program, and by using the finding in a similar study in the literature, it was used with 80% power and 5% margin of error to catch the medium effect size between dependent measurements. It was decided to work with a total of minimum 60 people, 20 in each group.Considering the patients who may be excluded from follow-up in the study, it is planned to start the study with 70 patients. The diagnosis of the disease will be made by clinical physical examination and enmg studies, and no additional technique will be required. Patients will be randomly divided into 3 groups. (They will be selected by simple random sampling using the closed envelope method, and then Group A (kinesio taping with I tape technique + exercise to tendon and median nerve slipping), Group B (kinesio taping with button hole technique + exercise to tendon and median nerve slipping) and They will be divided into Group C (tendon and median nerve gliding exercise). In the first group, kinesio taping with the I tape technique described by Dr Kenzo Kase will be applied once a week, a total of 3 times, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day. In the second group, kinesio taping with the Button hole technique defined by Dr Kenzo Kase will be applied once a week, 3 times in total, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day. In the third group, exercises will be taught to the patient and a total of 21 sessions will be applied once a day. Kinesiotaping application; It will be done by a physical therapist who has a kinesiology taping course certificate. I tape technique: In this technique, an I tape is measured and cut from the heads of the metacarpals to the epicondyles of the humerus. The ends of the tape are cut and an x shape is obtained at the ends. The tape is folded to find the middle point, then the paper is torn and, starting from the middle point, the patient's wrist and elbow are moved to the extension of the palmaris longus entrance. distally, below the antecubital fossa, the lower forearm is adhered to the carpal tunnel region with mild-light (15-25%) tension. Taping is applied to the wrist from the dorsal side again with a field correction technique. With the wrist slightly flexed, the middle part of a 15-20 cm I tape is adhered to the distal radius and ulna from the dorsal face with very light-light (15-25%) tension. With one hand, the band is held over the styloid processes of the radius and ulna, and with the other hand, the wrist is extended. The remaining ends are cut and glued without tension, leaving a small gap between both ends. Buttonhole: In this technique, a kinesio tape is measured and cut from the medial and lateral epicondyle level on the palmar side of the forearm, from the base of the proximal phalanges to the humerus epicondyles on the dorsal surface of the forearm. The tape is folded and the middle point is found there by making 2 short incisions and 2 holes through which it will pass between the 3rd and 4th fingers. (button holes) are obtained. The paper on the back of the tape is torn and the 2nd and 3rd fingers are passed through the holes. The patient's wrist is extended and radial deviation is brought, and the band is adhered to the medial epicondyle of the forearm with very light-mild (15-25%) tension. Then, the wrist is flexed and ulnar deviation is brought, and it is adhered to the lateral epicondyle with very light-mild (15-25%) tension. The last 3-5 centimeters are adhered without tension. Taping is applied to the wrist from the dorsal side again with a field correction technique. With the wrist slightly flexed, the middle part of a 15-20 cm I tape is adhered to the distal radius and ulna from the dorsal face with very light-light (15-25%) tension. With one hand, the band is held over the styloid processes of the radius and ulna, and with the other hand, the wrist is extended. The remaining ends are cut and glued without tension, with a small gap between both ends.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
kinesiotaping, electrophysiological findings, carpal tunel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly divided into 3 groups.Group A (kinesio taping with I tape technique + exercise to tendon and median nerve slipping), Group B (kinesio taping with button hole technique + exercise to tendon and median nerve slipping) and They will be divided into Group C (tendon and median nerve gliding exercise). In the first group, kinesio taping with the I tape technique described by Dr Kenzo Kase will be applied once a week, a total of 3 times, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day. In the second group, kinesio taping with the Button hole technique defined by Dr Kenzo Kase will be applied once a week, 3 times in total, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day. In the third group, exercises will be taught to the patient and a total of 21 sessions will be applied once a day.
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator and Outcomes Assessor are blind.
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I tape technique
Arm Type
Active Comparator
Arm Description
I tape technique described by Dr Kenzo Kase will be applied once a week, a total of 3 times, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day.
Arm Title
Button hole technique
Arm Type
Active Comparator
Arm Description
Button hole technique defined by Dr Kenzo Kase will be applied once a week, 3 times in total, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day.
Arm Title
exercises
Arm Type
Other
Arm Description
exercises will be taught to the patient and a total of 21 sessions will be applied once a day.
Intervention Type
Other
Intervention Name(s)
I tape technique
Intervention Description
I tape technique described by Dr Kenzo Kase will be applied once a week, a total of 3 times, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day.
Intervention Type
Other
Intervention Name(s)
Button hole technique
Intervention Description
Button hole technique defined by Dr Kenzo Kase will be applied once a week, 3 times in total, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day.
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
exercises will be taught to the patient and a total of 21 sessions will be applied once a day
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Time Frame
0 (baseline)
Title
Visual Analog Scale
Description
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Time Frame
3 th week
Title
Visual Analog Scale
Description
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Time Frame
12 th week
Title
Hand grip strength
Description
Jamar dynamometer will be used to measure hand grip strength. Jamar dynamometer measures static grip strength in pounds and kilograms. Measurements will be made with the patient in a sitting position, arm adducted, elbow flexed to 90 degrees, forearm in neutral position, as recommended by the American Association of Hand Therapists. Patients are asked to squeeze the dynamometer for at least 3 seconds with maximum contraction. 3 measurements are made with a 1 minute break between measurements. The average of 3 measurements is recorded in kilograms
Time Frame
0 (baseline)
Title
hand grip strength
Description
Jamar dynamometer will be used to measure hand grip strength. Jamar dynamometer measures static grip strength in pounds and kilograms. Measurements will be made with the patient in a sitting position, arm adducted, elbow flexed to 90 degrees, forearm in neutral position, as recommended by the American Association of Hand Therapists. Patients are asked to squeeze the dynamometer for at least 3 seconds with maximum contraction. 3 measurements are made with a 1 minute break between measurements. The average of 3 measurements is recorded in kilograms
Time Frame
3 th week
Title
hand grip strength
Description
Jamar dynamometer will be used to measure hand grip strength. Jamar dynamometer measures static grip strength in pounds and kilograms. Measurements will be made with the patient in a sitting position, arm adducted, elbow flexed to 90 degrees, forearm in neutral position, as recommended by the American Association of Hand Therapists. Patients are asked to squeeze the dynamometer for at least 3 seconds with maximum contraction. 3 measurements are made with a 1 minute break between measurements. The average of 3 measurements is recorded in kilograms
Time Frame
12 th week
Title
electrophysiologıcal Findings
Description
Median sensory nerve action potential amplitude, Compound muscle action potential amplitude, Median sensory distal latency, Median motor distal latency, Median sensory nerve conduction velocity, was evaluated by EMG.
Time Frame
0 (baseline)
Title
electrophysiologıcal Findings
Description
Median sensory nerve action potential amplitude, Compound muscle action potential amplitude, Median sensory distal latency, Median motor distal latency, Median sensory nerve conduction velocity, was evaluated by EMG.
Time Frame
3 th week
Title
electrophysiologıcal Findings
Description
Median sensory nerve action potential amplitude, Compound muscle action potential amplitude, Median sensory distal latency, Median motor distal latency, Median sensory nerve conduction velocity, was evaluated by EMG.
Time Frame
12 th week
Secondary Outcome Measure Information:
Title
function
Description
The Boston carpal tunnel questionnaire (BCTA) has been proposed for clinical standardization of CTS patients. It consists of nineteen questions and the answers are evaluated with a minimum of one and a maximum of five points. A high mean score indicates that the patient's complaints are severe or that their functional capacity is insufficient. The symptom severity score is the average of the eleven questions and the functional capacity score of the eight questions.
Time Frame
0 (baseline)
Title
function
Description
The Boston carpal tunnel questionnaire (BCTA) has been proposed for clinical standardization of CTS patients. It consists of nineteen questions and the answers are evaluated with a minimum of one and a maximum of five points. A high mean score indicates that the patient's complaints are severe or that their functional capacity is insufficient. The symptom severity score is the average of the eleven questions and the functional capacity score of the eight questions.
Time Frame
3 th week
Title
function
Description
The Boston carpal tunnel questionnaire (BCTA) has been proposed for clinical standardization of CTS patients. It consists of nineteen questions and the answers are evaluated with a minimum of one and a maximum of five points. A high mean score indicates that the patient's complaints are severe or that their functional capacity is insufficient. The symptom severity score is the average of the eleven questions and the functional capacity score of the eight questions.
Time Frame
12 th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female and male patients aged 18-65 years who applied to Ahi Evran University Physical Medicine and Rehabilitation Outpatient Clinic and diagnosed with mild to moderate carpal tunnel syndrome by clinical and EMG Patients who can correctly understand what is stated in the patient information form and have cooperation Patients who consented to participate in the study according to the informed consent form Exclusion Criteria: Cervical radiculopathy Polyneuropathy Brachial plexopathy Systemic corticosteroid use History of fracture and trauma in the treated side forearm and wrist Inflammatory rheumatic disease Pregnant and lactating patients Systemic diseases such as renal insufficiency, peptic ulcer, DM, hypothyroidism, coagulation disorder Patients undergoing carpal tunnel syndrome surgery Thoracic outlet syndrome Thenar atrophy, severe carpal tunnel syndrome The patient is reluctant or states that he cannot participate for any reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basak Cigdem Karacay, Asisst Prof
Organizational Affiliation
Kirsehir Ahi Evran Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahi Evran University
City
Kirşehir
State/Province
City Centre
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27513402
Citation
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.
Results Reference
background
PubMed Identifier
30384555
Citation
Yildirim P, Dilek B, Sahin E, Gulbahar S, Kizil R. Ultrasonographic and clinical evaluation of additional contribution of kinesiotaping to tendon and nerve gliding exercises in the treatment of carpal tunnel syndrome. Turk J Med Sci. 2018 Oct 31;48(5):925-932. doi: 10.3906/sag-1709-72.
Results Reference
background
PubMed Identifier
32893100
Citation
Krause D, Roll SC, Javaherian-Dysinger H, Daher N. Comparative efficacy of the dorsal application of Kinesio tape and splinting for carpal tunnel syndrome: A randomized controlled trial. J Hand Ther. 2021 Jul-Sep;34(3):351-361. doi: 10.1016/j.jht.2020.03.010. Epub 2020 Sep 4.
Results Reference
result

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Effect of the Kinesiotaping on paın, Function and electrophysiologıcal Findings in Patient With Carpal Tunnel Syndrome

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