Carpal Tunnel SyndromeNCT05821127
Effect of Neurodynamic Exercises and Education Program Applied With Virtual Reality Assisted Telerehabilitation Method in Conservative Treatment of Carpal Tunnel Syndrome
A study testing Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method and Neurodynamic Exercises and Patient Education with Traditional Method in people with Carpal Tunnel Syndrome and Peripheral Neuropathy, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Peripheral Neuropathy, Median Nerve Entrapment
- What is being tested?
- Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method and Neurodynamic Exercises and Patient Education with Traditional Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 23 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years
- Being diagnosed with CTS clinically and electrophysiologically
Who cannot join
- <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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Istanbul, 34093
About this study
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
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.
- Being tested
- Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method, Neurodynamic Exercises and Patient Education with Traditional Method
- Keywords
- Carpal Tunnel Syndrome, Virtual Reality, Telerehabilitation, Exercise, Education, Ergonomics
- Medical subject headings
- Carpal Tunnel Syndrome, Peripheral Nervous System Diseases, Median Neuropathy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation MethodBehavioural
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.
Neurodynamic Exercises and Patient Education with Traditional MethodBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Neurodynamic Exercises and Patient Education with Traditional Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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'.
Measured: baseline, eight week of intervention, sixteen week of intervention
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).
Measured: baseline, eight week of intervention, sixteen week of intervention
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.
Measured: baseline, eight week of intervention, sixteen week of intervention
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.
Measured: baseline, eight week of intervention, sixteen week of intervention
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).
Measured: baseline, eight week of intervention, sixteen week of intervention
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.
Measured: baseline, eight week of intervention, sixteen week of intervention
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.
Measured: baseline, eight week of intervention, sixteen week of intervention
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.
Measured: baseline, eight week of intervention, sixteen week of intervention
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.
Measured: baseline, eight week of intervention, sixteen week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start15 Apr 2023
- Primary completion15 Apr 2024
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baran Sezgin, Istanbul University
- Investigators
- Baran Sezgin, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821127
- Sponsor's protocol ID
- Istanbul University, Turkey
- Status last verified
- May 2025
- First submitted
- 6 Apr 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05821127
- Acronym / sponsor ID
- Istanbul University, Turkey
- Keywords
- Carpal Tunnel Syndrome, Virtual Reality, Telerehabilitation, Exercise, Education, Ergonomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method | Experimental | Behavioral: Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation MethodPatient 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. |
| Neurodynamic Exercises and Patient Education with Traditional Method | Active comparator | Behavioral: Neurodynamic Exercises and Patient Education with Traditional MethodParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years
- Being diagnosed with CTS clinically and electrophysiologically
Key exclusion criteria (17 listed)
- <18 years or >65 years
- Distal motor latency > 6.0 msn.
- Thenar atrophy
- Surgery history for CTS
- Steroid injection for CTS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation MethodA 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. | Behavioural | Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method |
| Neurodynamic Exercises and Patient Education with Traditional MethodA 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. | Behavioural | Neurodynamic Exercises and Patient Education with Traditional Method |
Primary outcome
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.
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.
9 secondary outcomes
Change in Brief International Classification of Functioning (ICF) Core Set for Hand Conditions Questionnaire
Time frame: baseline, eight week of intervention, sixteen week of intervention
Change in Short Form-36 (SF-36) Questionnaire
Time frame: baseline, eight week of intervention, sixteen week of intervention
Change in Semmes Weinstein Monofilament Test (SWMT)
Time frame: baseline, eight week of intervention, sixteen week of intervention
Change in Two Point Discrimination Test (TPDT)
Time frame: baseline, eight week of intervention, sixteen week of intervention
Change in Hand Grip Force
Time frame: baseline, eight week of intervention, sixteen week of intervention
Change in Thumb and Forefinger Pinch Force
Time frame: baseline, eight week of intervention, sixteen week of intervention
Change in Manuel Muscle Testing of M. Abductor Pollicis Brevis
Time frame: baseline, eight week of intervention, sixteen week of intervention
Change in Vibration Sensation
Time frame: baseline, eight week of intervention, sixteen week of intervention
Change in Nerve Conduction Study (NCS)
Time frame: baseline, eight week of intervention, sixteen week of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baran Sezgin, MD principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Assisted Neurodynamic Exercises and Patient Education with Telerehabilitation Method and Neurodynamic Exercises and Patient Education with Traditional Method in people with Carpal Tunnel Syndrome and Peripheral Neuropathy, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) (time frame: baseline, eight week of intervention, sixteen week of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.