Investigation of the Efficacy of Virtual Reality Mediated Neurodynamic Exercises in Carpal Tunnel Syndrome

March 16, 2023 updated by: Ahmet Kivanc Menekseoglu, Istanbul University

Investigation of the Efficacy of Virtual Reality Mediated Neurodynamic Exercises in Carpal Tunnel Syndrome: A Prospective Randomized Controlled Clinical Study

Carpal tunnel syndrome (CTS) is the most common nerve entrapment syndrome. It occurs as a result of compression of the median nerve as it passes through a restricted osteofibrous canal in the wrist. Known as the carpal tunnel, this canal contains the wrist bones, transverse carpal ligament, median nerve, and digital flexor tendons. Edema, tendon inflammation, hormonal changes, and manual activity can contribute to increased nerve compression and sometimes cause pain.

In this research, the investigators aim to present the virtual reality-mediated exercise program to patients non-immersive. It is planned to use the Leap Motion motion sensor to detect hand and wrist movements and to monitor the gamified setup on the computer screen.

In the system that will be presented via computer and hand motion sensor, the patient will be asked to perform therapeutic exercises for the diagnosis of CTS in a scenario developed through virtual reality. The investigators predict that patients will actively participate in virtual reality-mediated therapeutic exercise program with high motivation and their functional results will be better than classical exercise programs.

In our research, the investigators aim to present the tendon and nerve gliding exercises with proven effectiveness in patients with CTS, with non-immersive virtual reality systems, and to compare their effectiveness with the classical exercise program.

Study Overview

Detailed Description

Carpal tunnel syndrome (CTS) is the most common nerve entrapment syndrome. It occurs as a result of compression of the median nerve as it passes through a restricted osteofibrous canal in the wrist. Known as the carpal tunnel, this canal contains the wrist bones, transverse carpal ligament, median nerve, and digital flexor tendons. Edema, tendon inflammation, hormonal changes, and manual activity can contribute to increased nerve compression and sometimes cause pain. In more severe cases, weakness may occur in the muscles innervated by the median nerve, resulting in weakness in hand muscle strength(1). In a comprehensive study, the mean age for the diagnosis of CTS was found to be 50 years, and its prevalence was found to be similar in men and women. However, the prevalence was higher in women; The incidence in women aged 65-74 was found to be four times higher than in men(2).

Many different treatment methods are used in the treatment of CTS, and these treatments include regulation of daily activities, use of splints, tendon and nerve gliding exercises, ESWT, manual therapy, kinesiotaping, physical therapy agents, medical symptomatic treatments, injections into the carpal tunnel and surgical treatment options. .

Suspected risk factors for CTS include diabetes mellitus, menopause, hypothyroidism, obesity, arthritis, and pregnancy. Since hypothyroidism, menopause, and pregnancy are risk factors, there is a strong suspicion that hormonal changes may play a role in the etiology of CTS; however, no evidence was found to support this hypothesis.

In the diagnosis of CTS, a comprehensive and accurate clinical history should be taken together with the exclusion of other possible causes. The syndrome is characterized by intermittent and then increasing nocturnal paresthesia and dysesthesia findings. Later, sensory loss develops with hand muscle weakness and muscle atrophy of the thenar region, resulting from extensive axonal degeneration in the course of the disease. This set of symptoms is quite typical and rarely occurs in disorders other than CTS. In severe CTS cases, paresthesia symptoms may spread to the proximal forearm and upper arm, and sometimes to the shoulder(3).

In the following periods, loss of strength and atrophy of the thenar region muscles may occur. The diagnosis is made by clinical examination, electrophysiological methods (EMG) and imaging methods (such as ultrasound, magnetic resonance imaging). The clinical examination consists of sensory-motor examination and provocative tests. 1-2-3 on sensory examination. numbness with touch (paresthesia) or low sense of touch (hypoesthesia) in the fingers are detected. Motor examination may be normal in the early stage, and later on, weakness (weakness) in the thumb abducting and opposing muscle is detected.

In the first of the provocative tests, when the inside of the patient's wrist is hit with a reflex hammer, the patient usually feels an electric shock sensation in the first 3 fingers of the hand or a tingling sensation spreading to these fingers. This is known as Tinel's sign. In another clinical test, the patient is asked to flex both wrists (both wrists are flexed and the backs of both hands are touching each other) for 1 minute. In case of numbness and tingling spreading to the fingers, the test is considered positive (significant). , this is called the 'Phalen test'. Another diagnostic method, EMG, is performed by recording and evaluating electrical signals coming from nerves and muscles, using electricity and needles to diagnose nerve and muscle diseases. In CTS, a decrease in the conduction velocity of the median nerve is detected. In the diagnosis of CTS, the diagnosis is mostly made when the clinical picture and electrophysiological findings are evaluated well, but magnetic resonance imaging may be useful in some special cases (formations such as space-occupying tumors).

CTS treatment is divided into conservative and surgical. Conservative treatment methods include splinting (an assistive device worn on the body to relieve the nerve), exercise (sliding movements of the median nerve in the wrist and wrist flexor tendons), local corticosteroid injection (corticosteroid injection into the carpal tunnel), and ultrasound (deep with sound energy) from physical therapy applications. tissue heating), TENS (pain relief by applying controlled low-voltage electric current to the nervous system through the skin with electrodes placed on the skin), paraffin bath (immersion of the hand in a heated paraffin pool), ergonomic arrangements. Surgical treatment includes decompression of the nerve (4).

Virtual reality; It is defined as the use of interactive simulations created with computer hardware and software to offer users opportunities to enter environments that look and feel like real-world objects and events. With the feeling of being in that environment and the possibility of interacting with the environment, it differs from products such as video and television(5).

Virtual reality applications are grouped under 2 main headings as "immersive" and "non-immersive" according to the level of user coverage of the environment. The degree of inclusiveness of the offered virtual environment depends on the level of interaction, as well as the ability to isolate the user from stimuli outside the virtual environment (such as external sounds and lights). In immersive virtual reality systems, head-mounted screens (in the form of head-mounted display; headgear, mask or glasses) are used, while non-immersive virtual reality systems use screens(6). In this research the investigators aim to present the virtual reality-mediated exercise program to patients non-immersive. It is planned to use the Leap Motion motion sensor to detect hand and wrist movements and to monitor the gamified setup on the computer screen. The Leap Motion sensor is a hand motion sensor that rests on a stable platform and has no wearable or mountable parts on the patient. The Leap Motion sensor, whose main use is to control computers hands-free, has no potential harm to patients. Within the scope of this research, no part will be placed on the hand or wrist of the patients, they will only be asked to move their hands at a distance of 30 cm from the relevant sensor.

In the system that will be presented via computer and hand motion sensor, the patient will be asked to perform therapeutic exercises for the diagnosis of CTS in a scenario developed through virtual reality. The investigators predict that patients will actively participate in virtual reality-mediated therapeutic exercise program with high motivation and their functional results will be better than classical exercise programs.

The use of different rehabilitation protocols, which are also referred to as "serious games" in the medical field, in gamification and treatment has recently attracted attention. Virtual reality-mediated exercises are used for neurological rehabilitation to reduce disability caused by different neurological diseases such as cerebral palsy, stroke, Parkinson's Disease, multiple sclerosis, neurodegenerative diseases(7). In addition to neurological diseases, virtual reality-based rehabilitation methods; It has also been used in studies for scoliosis exercises, cardiac rehabilitation, chronic pain management, and pulmonary rehabilitation and its effectiveness has been demonstrated (8,9,10).

In our research, the investigators aim to present the tendon and nerve gliding exercises with proven effectiveness in patients with CTS, with non-immersive virtual reality systems, and to compare their effectiveness with the classical exercise program.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Istanbul, Turkey, 34015
        • Ahmet Kıvanç Menekşeoğlu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having an EMG of the last 1 year and a diagnosis of mild and moderate CTS in this EMG,
  • Between the ages of 20-70,
  • Using a resting splint for the diagnosis of CTS,
  • It was determined that he agreed to participate in the exercise program and to stop other therapeutic interventions to be applied to the wrist during the 3-month follow-up period.

Exclusion Criteria:

  • Having a history of Cervical Radiculopathy,
  • Having a diagnosis of rheumatoid arthritis,
  • Having a history of acute trauma,
  • Steroid injection to the wrist in the last 3 months,
  • Having undergone wrist surgery in the last 3 months,
  • Having an open wound around the wrist,
  • Presence of uncontrolled disease (endocrinological, cardiovascular, pulmonary, hematological, hepatic, renal) was determined as patients with a history of active systemic inflammatory disease and/or malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Group
Tendon and nerve gliding exercises will be applied to the patients in the virtual reality group for 2 weeks, for a total of 10 sessions, through the developed software. Patients will be asked to come for 2 weeks for the virtual reality mediated exercise program. Patients will be asked to do their exercises in a virtual reality-mediated exercise protocol, with 1 session of approximately 30 minutes. Apart from the exercise program, patients will be asked to use wrist splints.
Patients participating in the study will not receive any intervention other than exercise and splint.
Patients participating in the study will not receive any intervention other than exercise and splint.
Active Comparator: Conventional Exercise Group
For the patients in the classical exercise group; The classical exercise program will be taught in the company of a physiotherapist and they will be asked to do these exercises for a total of 10 sessions for 2 weeks. The patients' home exercise programs will be controlled by weekly phone calls. Apart from the exercise program, patients will be asked to use wrist splints.
Patients participating in the study will not receive any intervention other than exercise and splint.
Patients participating in the study will not receive any intervention other than exercise and splint.
Active Comparator: Control Group
Patients in the control group will be advised to continue using splints. It will be evaluated by repeated examinations.
Patients participating in the study will not receive any intervention other than exercise and splint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Carpal Tunnel Questionnaire
Time Frame: Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention.
It is used to assess symptom severity and functional capacity in CTS. This scale is scored between 19-95 points, with higher scores indicating worse results.
Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention.
Nerve conduction study
Time Frame: Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
It will be done to evaluate the involvement of the median nerve from CTS.
Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
Median nerve area
Time Frame: Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
The median nerve area will be measured by ultrasound.
Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
Visual Analog Scale
Time Frame: Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
Pain status will be evaluated with visual analog scale. This scale is scored between 0-10 points, with higher scores indicating worse results.
Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
Hand grip strength
Time Frame: Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
The hand grip and pinch strength of the patients will be evaluated with a dynamometer.
Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

September 24, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not planned to share patient and study information with third parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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