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

NCT05821127 | Completed

• 1 other identifier: Istanbul University, Turkey
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Peripheral Neuropathy; Median Nerve Entrapment

Keywords

Carpal Tunnel Syndrome; Virtual Reality; Telerehabilitation; Exercise; Education; Ergonomics

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline, eight week of intervention, sixteen week of intervention

• 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.

  baseline, eight week of intervention, sixteen week of intervention

Secondary Outcomes (9)

• 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 Two Point Discrimination Test (TPDT)

  baseline, eight week of intervention, sixteen week of intervention

• Change in Hand Grip Force

  baseline, eight week of intervention, sixteen week of intervention

Study Arms (2)

Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method

EXPERIMENTAL

Patient education was provided in 3 sessions via telerehabilitation method, and exercises were provided with virtual reality support. It was requested that the exercises be done in 6 sets (30 repetitions) every day. Participants were given a splint, exercise brochure, and exercise diary for use at night.

Behavioral: Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method

Neurodynamic Exercises and Patient Education with Traditional Method

ACTIVE COMPARATOR

Participants were given a single session of face-to-face training on the same topics, and were given a splint, exercise brochure and exercise diary to be used at night.

Behavioral: Neurodynamic Exercises and Patient Education with Traditional Method

Interventions

Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method BEHAVIORAL

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.

Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method

Neurodynamic Exercises and Patient Education with Traditional Method BEHAVIORAL

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.

Neurodynamic Exercises and Patient Education with Traditional Method

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Being diagnosed with CTS clinically and electrophysiologically

You may not qualify if:

• \<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
• History of trauma/fracture to the hand-wrist region
• Pregnancy
• Metabolic disease
• Rheumatic/autoimmune disease
• Kidney failure

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Peripheral Nervous System Diseases; Median Neuropathy; Motor Activity

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Mononeuropathies; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Baran Sezgin, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It was noted to which group the patient was allocated by referring to the list of random numbers created by a computer program by a researcher participating in the study. The treatment process for the intervention group and the control group was managed by the same researcher. Outcome evaluations before treatment and after 8 weeks of treatment follow-up were made by a second researcher who was blind to group distribution. The list of random numbers was hidden from the researcher making the evaluations, ensuring that the participants did not know which group they belonged to. Analysis of the data was done by a third researcher. The intervention group was coded as 'group 1' and the control group was coded as 'group 2'. With this method, it was ensured that the researcher performing the analysis did not know which group the patients belonged to. With this randomization and blinding process, the impartiality of the researchers was ensured.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A random number table containing numbers from 1 to 60 was created for 2 groups through the computer program. Participants were numbered in order of application. Participants were assigned to groups to which their numbers belonged in the table of random numbers.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 20, 2023
• Study Start: April 15, 2023
• Primary Completion: April 15, 2024
• Study Completion: May 23, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)