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

NCT05563909 | Completed

• 1 other identifier: 07/09/2020-142688
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (5)

• Boston Carpal Tunnel Questionnaire

  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

  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

  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

  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

  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

Study Arms (3)

Virtual Reality Group

EXPERIMENTAL

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.

Other: Wrist Splint; Other: Virtual Reality Mediated Exercise

Conventional Exercise Group

ACTIVE COMPARATOR

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.

Other: Exercise; Other: Wrist Splint

Control Group

ACTIVE COMPARATOR

Patients in the control group will be advised to continue using splints. It will be evaluated by repeated examinations.

Other: Wrist Splint

Interventions

Exercise OTHER

Patients participating in the study will not receive any intervention other than exercise and splint.

Conventional Exercise Group

Wrist Splint OTHER

Patients participating in the study will not receive any intervention other than exercise and splint.

Control Group; Conventional Exercise Group; Virtual Reality Group

Virtual Reality Mediated Exercise OTHER

Patients participating in the study will not receive any intervention other than exercise and splint.

Virtual Reality Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Ahmet Kıvanç Menekşeoğlu

Istanbul, 34015, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher evaluating the participants will be blind to the group distributions.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 54 patients with CTS who met the inclusion criteria will be included in this prospectively planned study. At the beginning of the study, 54 patients with a diagnosis of CTS who met the inclusion criteria will be randomized into three groups according to the random order created by a computer program after being numbered according to the general polyclinic application order of Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation.

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: October 3, 2022
• Study Start: October 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)