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Effect of Neurodynamic Exercises and Education Program Applied With Virtual Reality Assisted Telerehabilitation Method in Conservative Treatment of Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome, Peripheral Neuropathy, Median Nerve Entrapment

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method
Neurodynamic Exercises and Patient Education with Traditional Method
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Virtual Reality, Telerehabilitation, Exercise, Education, Ergonomics

Eligibility Criteria

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

Inclusion Criteria: 18-65 years Being diagnosed with CTS clinically and electrophysiologically Exclusion Criteria: <18 years or >65 years Distal motor latency > 4.5 msn. Thenar atrophy Surgery history for CTS Steroid injection for CTS Physical treatment for CTS in the last 6 months Cervical radiculopathy Tenosynovitis Peripheral polyneuropathy Another compressive neuropathy in the ipsilateral upper extremity History of trauma/fracture to the hand-wrist region Pregnancy Metabolic disease Rheumatic/autoimmune disease Kidney failure Lack of internet access Not having the equipment to make video calls at home

Sites / Locations

  • Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method

Neurodynamic Exercises and Patient Education with Traditional Method

Arm Description

Outcomes

Primary Outcome Measures

Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
BCTSQ assesses the severity of symptoms and functional status in patients with carpal tunnel syndrome. The symptom severity scale assesses the symptoms with respect to severity, frequency, time and type. The scale consists of 11 questions with multiple-choice responses, scored from 1 point (mildest) to 5 points (most severe). The overall symptom severity score is calculated as the mean of the scores for the eleven individual items. The functional status scale assesses the affect of the carpal tunnel syndrome on daily living. The scale consists of 8 questions with multiple choice responses, scored from 1 point (no difficulty with the activity) to 5 points (can not perform the activity at all). The overall score for functional status was calculated as the mean of all eight. Thus, a higher symptom severity or functional status score indicates worse symptoms or dysfunction.
Change in Visual Pain Scale (VAS)
The VAS is a single-item measure, that is, an instrument measuring the whole construct at once. VAS most commonly consists of a 100mm horizontal line anchored with two opposite labels; patients mark a score on the scale using a vertical line. Using this scale, patients will be asked to rate the severity of pain and numbness they feel during the night and in daytime at rest, and with activity between 0 and 100 points.

Secondary Outcome Measures

Change in Brief International Classification of Functioning (ICF) Core Set for Hand Conditions Questionnaire
The disorders caused by carpal tunnel syndrome in the patient's daily activities will be evaluated by using the 'ICF activities and participation codes' section of the 'Brief ICF Core Set for Hand Conditions'.
Change in Short Form-36 (SF-36) Questionnaire
The SF-36 is a 36 item questionnaire that measures eight multi-item dimensions of health: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain and general health perception. For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).
Change in Semmes Weinstein Monofilament Test (SWMT)
Using 20 pieces of SWMT, sensitive touch threshold sensitivity of each hand will be tested. The examiner and the subject will seated opposite each other. Both arms of the subject will arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. The monofilaments will be touched fingertips of first three fingers on the radial side of both hands, with enough force to bend the monofilament for 1.5 seconds. The thinnest monofilament numbers that the patient feels being touched will be recorded. The thinnest monofilament number among the three measurements will be noted as a result. Absence of sensation at a threshold of 2.83 in any of the three fingers tested indicates loss of sensation.
Change in Two Point Discrimination Test (TPDT)
Two point discrimination sense will be evaluated statically and dynamically using an esthesiometer. The examiner and the subject will seated opposite each other. Both arms of the subject will arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. The contact time of the discriminator with the fingertip ranged from 3 to 5 seconds. The evaluation will be started by touching a single point on the first three fingertips on the radial side of both hands. Each three fingers will be evaluated separately and the distance between the two touched points will be increased by 1mm in each measurement. The smallest values will be taken in millimeters which the patient feels the two points as two separate points on the tested hand will be noted and the the average value written as the result.
Change in Hand Grip Force
The squeeze force will be measured while the patients are sitting, with the elbow in 90 degrees flexion and they will be asked to make a maximally voluntary grip. Measurements will be made three times in a row on both hands and the average of the three measurements will be noted as a result in kilogram (kg).
Change in Thumb and Forefinger Pinch Force
The pinch force with thumb and forefinger will be measured while the patients are sitting, with the elbow in 90 degrees flexion and they will be asked to make a maximally voluntary grip.The pinch force will be measured as kg with a pinch dynamometer, and the average of the three measurements will be noted as a result.
Change in Manuel Muscle Testing of M. Abductor Pollicis Brevis
Manual muscle testing will be evaluated in 5 grades. No visible or palpable muscle contraction 0, visible or palpable muscle contraction without motion grade 1, muscle contraction that creates movement at full of range of motion when gravity is eliminated grade 2, muscle contraction that creates movement at full of range of motion against gravity grade 3, muscle contraction that creates movement at full of range of motion against gravity and moderate resistance grade 4, muscle contraction that creates movement through the entire range of motion of the joint against gravity and full resistance will be considered as the grade 5.
Change in Vibration Sensation
Vibration sense was tested with tuning fork. The normal vibration sensory threshold for the upper extremity was accepted as 20 seconds. The examiner and the subject will seated opposite each other. Both arms of the subject will arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. Vibrating tuning fork will be placed on the palmar aspect of the distal phalanx of first three fingers on the radial side of both hands, The patient was asked to say 'done' when the vibration in his hand was over. The average of three measurements will be noted as a result in seconds.
Change in Nerve Conduction Study (NCS)
Median motor distal latency and conduction velocity and second finger recorded median sensory distal latency and conduction velocity will be measured antidromically in all individuals. In addition to routine conduction examinations, fourth finger recorded median-ulnar peak latency comparison examinations will also be made.

Full Information

First Posted
April 6, 2023
Last Updated
July 11, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05821127
Brief Title
Effect of Neurodynamic Exercises and Education Program Applied With Virtual Reality Assisted Telerehabilitation Method in Conservative Treatment of Carpal Tunnel Syndrome
Official Title
The Effect of Neurodynamic Exercises and Education Program Applied With Virtual Reality Assisted Telerehabilitation Method in Conservative Treatment of Carpal Tunnel Syndrome: A Single-Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim in this prospective, randomized and controlled, single-blind study; In the conservative treatment of patients diagnosed with carpal tunnel syndrome, to investigate the effects of neurodynamic exercises that applied with nonimmersive virtual reality technology and patient education program presented by the telerehabilitation method on pain-numbness, functional status and quality of life, to compare the effects of neurodynamic exercises that applied with traditional methods and standard education given to patients in outpatient clinic conditions on the same parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Peripheral Neuropathy, Median Nerve Entrapment
Keywords
Carpal Tunnel Syndrome, Virtual Reality, Telerehabilitation, Exercise, Education, Ergonomics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method
Arm Type
Experimental
Arm Title
Neurodynamic Exercises and Patient Education with Traditional Method
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method
Intervention Description
A brochure showing the execution of median nerve and tendon gliding exercises and a wrist brace for night use will be provided. In addition, 2 sessions of patient education will be provided with videoconference calls, and with the mobile application to be installed on the phones of the patients as non-immersive virtual reality support, it will be possible to practice median nerve and tendon gliding exercises in the form of 5 repetitions and 6 sets every day with video support for 16 weeks. In this application, the user will use the front camera of phone as a sensor to detect hand movements. A screen on which exercises will be played at the top of the screen and a virtual image of the user's hand in the lower half of the screen will be displayed in the field of view of the camera. Each exercise position will take 5 seconds. Patient education will include neuroscience, etiology, pathophysiology and treatment options of carpal tunnel syndrome, ergonomics and posture education.
Intervention Type
Behavioral
Intervention Name(s)
Neurodynamic Exercises and Patient Education with Traditional Method
Intervention Description
A brochure showing the execution of median nerve and tendon gliding exercises and a wrist brace for night use will be provided. Patients will be asked to do the exercises in the form of 5 repetitions and 6 sets every day and to wear the night splint every night for 16 weeks. Each exercise position will take 5 seconds. A brief verbal education will be given to the patients under the same topics as the intervention group, as in the outpatient clinic.
Primary Outcome Measure Information:
Title
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
Description
BCTSQ assesses the severity of symptoms and functional status in patients with carpal tunnel syndrome. The symptom severity scale assesses the symptoms with respect to severity, frequency, time and type. The scale consists of 11 questions with multiple-choice responses, scored from 1 point (mildest) to 5 points (most severe). The overall symptom severity score is calculated as the mean of the scores for the eleven individual items. The functional status scale assesses the affect of the carpal tunnel syndrome on daily living. The scale consists of 8 questions with multiple choice responses, scored from 1 point (no difficulty with the activity) to 5 points (can not perform the activity at all). The overall score for functional status was calculated as the mean of all eight. Thus, a higher symptom severity or functional status score indicates worse symptoms or dysfunction.
Time Frame
baseline, eight week of intervention, sixteen week of intervention
Title
Change in Visual Pain Scale (VAS)
Description
The VAS is a single-item measure, that is, an instrument measuring the whole construct at once. VAS most commonly consists of a 100mm horizontal line anchored with two opposite labels; patients mark a score on the scale using a vertical line. Using this scale, patients will be asked to rate the severity of pain and numbness they feel during the night and in daytime at rest, and with activity between 0 and 100 points.
Time Frame
baseline, eight week of intervention, sixteen week of intervention
Secondary Outcome Measure Information:
Title
Change in Brief International Classification of Functioning (ICF) Core Set for Hand Conditions Questionnaire
Description
The disorders caused by carpal tunnel syndrome in the patient's daily activities will be evaluated by using the 'ICF activities and participation codes' section of the 'Brief ICF Core Set for Hand Conditions'.
Time Frame
baseline, eight week of intervention, sixteen week of intervention
Title
Change in Short Form-36 (SF-36) Questionnaire
Description
The SF-36 is a 36 item questionnaire that measures eight multi-item dimensions of health: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain and general health perception. For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).
Time Frame
baseline, eight week of intervention, sixteen week of intervention
Title
Change in Semmes Weinstein Monofilament Test (SWMT)
Description
Using 20 pieces of SWMT, sensitive touch threshold sensitivity of each hand will be tested. The examiner and the subject will seated opposite each other. Both arms of the subject will arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. The monofilaments will be touched fingertips of first three fingers on the radial side of both hands, with enough force to bend the monofilament for 1.5 seconds. The thinnest monofilament numbers that the patient feels being touched will be recorded. The thinnest monofilament number among the three measurements will be noted as a result. Absence of sensation at a threshold of 2.83 in any of the three fingers tested indicates loss of sensation.
Time Frame
baseline, eight week of intervention, sixteen week of intervention
Title
Change in Two Point Discrimination Test (TPDT)
Description
Two point discrimination sense will be evaluated statically and dynamically using an esthesiometer. The examiner and the subject will seated opposite each other. Both arms of the subject will arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. The contact time of the discriminator with the fingertip ranged from 3 to 5 seconds. The evaluation will be started by touching a single point on the first three fingertips on the radial side of both hands. Each three fingers will be evaluated separately and the distance between the two touched points will be increased by 1mm in each measurement. The smallest values will be taken in millimeters which the patient feels the two points as two separate points on the tested hand will be noted and the the average value written as the result.
Time Frame
baseline, eight week of intervention, sixteen week of intervention
Title
Change in Hand Grip Force
Description
The squeeze force will be measured while the patients are sitting, with the elbow in 90 degrees flexion and they will be asked to make a maximally voluntary grip. Measurements will be made three times in a row on both hands and the average of the three measurements will be noted as a result in kilogram (kg).
Time Frame
baseline, eight week of intervention, sixteen week of intervention
Title
Change in Thumb and Forefinger Pinch Force
Description
The pinch force with thumb and forefinger will be measured while the patients are sitting, with the elbow in 90 degrees flexion and they will be asked to make a maximally voluntary grip.The pinch force will be measured as kg with a pinch dynamometer, and the average of the three measurements will be noted as a result.
Time Frame
baseline, eight week of intervention, sixteen week of intervention
Title
Change in Manuel Muscle Testing of M. Abductor Pollicis Brevis
Description
Manual muscle testing will be evaluated in 5 grades. No visible or palpable muscle contraction 0, visible or palpable muscle contraction without motion grade 1, muscle contraction that creates movement at full of range of motion when gravity is eliminated grade 2, muscle contraction that creates movement at full of range of motion against gravity grade 3, muscle contraction that creates movement at full of range of motion against gravity and moderate resistance grade 4, muscle contraction that creates movement through the entire range of motion of the joint against gravity and full resistance will be considered as the grade 5.
Time Frame
baseline, eight week of intervention, sixteen week of intervention
Title
Change in Vibration Sensation
Description
Vibration sense was tested with tuning fork. The normal vibration sensory threshold for the upper extremity was accepted as 20 seconds. The examiner and the subject will seated opposite each other. Both arms of the subject will arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. Vibrating tuning fork will be placed on the palmar aspect of the distal phalanx of first three fingers on the radial side of both hands, The patient was asked to say 'done' when the vibration in his hand was over. The average of three measurements will be noted as a result in seconds.
Time Frame
baseline, eight week of intervention, sixteen week of intervention
Title
Change in Nerve Conduction Study (NCS)
Description
Median motor distal latency and conduction velocity and second finger recorded median sensory distal latency and conduction velocity will be measured antidromically in all individuals. In addition to routine conduction examinations, fourth finger recorded median-ulnar peak latency comparison examinations will also be made.
Time Frame
baseline, eight week of intervention, sixteen week of intervention

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: 18-65 years Being diagnosed with CTS clinically and electrophysiologically Exclusion Criteria: <18 years or >65 years Distal motor latency > 4.5 msn. Thenar atrophy Surgery history for CTS Steroid injection for CTS Physical treatment for CTS in the last 6 months Cervical radiculopathy Tenosynovitis Peripheral polyneuropathy Another compressive neuropathy in the ipsilateral upper extremity History of trauma/fracture to the hand-wrist region Pregnancy Metabolic disease Rheumatic/autoimmune disease Kidney failure Lack of internet access Not having the equipment to make video calls at home
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baran Sezgin, MD
Phone
+902124142000
Ext
31737
Email
baranszgn94@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baran Sezgin, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baran Sezgin, MD
Phone
+902124142000
Ext
31737
Email
baranszgn94@gmail.com
First Name & Middle Initial & Last Name & Degree
Baran Sezgin, MD
First Name & Middle Initial & Last Name & Degree
Sina Arman, Associate professor
First Name & Middle Initial & Last Name & Degree
Serhat Yavuz, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Neurodynamic Exercises and Education Program Applied With Virtual Reality Assisted Telerehabilitation Method in Conservative Treatment of Carpal Tunnel Syndrome

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