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Clinical Trials/NCT05821127
NCT05821127
Completed
Not Applicable

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

Istanbul University1 site in 1 country60 target enrollmentApril 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Istanbul University
Enrollment
60
Locations
1
Primary Endpoint
Change in Visual Pain Scale (VAS)
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2023
End Date
May 23, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Baran Sezgin

Principal Investigator

Istanbul University

Eligibility Criteria

Inclusion Criteria

  • 18-65 years
  • Being diagnosed with CTS clinically and electrophysiologically

Exclusion Criteria

  • \<18 years or \>65 years
  • Distal motor latency \> 6.0 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

Outcomes

Primary Outcomes

Change in Visual Pain Scale (VAS)

Time Frame: baseline, eight week of intervention, sixteen week of intervention

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.

Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)

Time Frame: baseline, eight week of intervention, sixteen week of intervention

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.

Secondary Outcomes

  • Change in Hand Grip Force(baseline, eight week of intervention, sixteen week of intervention)
  • Change in Vibration Sensation(baseline, eight week of intervention, sixteen week of intervention)
  • Change in Nerve Conduction Study (NCS)(baseline, eight week of intervention, sixteen week of intervention)
  • Change in Brief International Classification of Functioning (ICF) Core Set for Hand Conditions Questionnaire(baseline, eight week of intervention, sixteen week of intervention)
  • Change in Short Form-36 (SF-36) Questionnaire(baseline, eight week of intervention, sixteen week of intervention)
  • Change in Semmes Weinstein Monofilament Test (SWMT)(baseline, eight week of intervention, sixteen week of intervention)
  • Change in Manuel Muscle Testing of M. Abductor Pollicis Brevis(baseline, eight week of intervention, sixteen week of intervention)
  • Change in Two Point Discrimination Test (TPDT)(baseline, eight week of intervention, sixteen week of intervention)
  • Change in Thumb and Forefinger Pinch Force(baseline, eight week of intervention, sixteen week of intervention)

Study Sites (1)

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