An interventional study of Primary Carpal Tunnel Release Surgery in Carpal Tunnel Syndrome (CTS), sponsored by Istanbul Medipol University Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment
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Carpal tunnel syndrome occurs when the median nerve is compressed at the wrist. It can cause pain, numbness, tingling, reduced hand strength, and difficulty performing daily activities. Carpal tunnel release surgery is commonly performed when symptoms do not improve with conservative treatment or when nerve compression is severe. However, recovery after surgery may differ between patients, and improvement in nerve conduction may not occur at the same rate as improvement in symptoms and hand function.
The purpose of this prospective observational study is to examine the relationship between electrophysiological recovery of the median nerve and clinical and functional recovery after carpal tunnel release surgery. Adults who are already scheduled to undergo primary carpal tunnel release as part of their routine clinical care will be invited to participate. The decision to perform surgery will be made by the treating physician independently of study participation.
Participants will undergo clinical and functional assessments before surgery and at postoperative week 8 These assessments will include questionnaires about carpal tunnel symptoms and upper-extremity function, pain severity, grip and pinch strength, sensory testing, and clinical examination. Nerve conduction studies will be evaluated before surgery and at postoperative month 3.
The study will assess whether changes in median nerve conduction are associated with changes in symptoms, upper-extremity function, pain, hand strength, and sensory function. The possible effects of age, sex, body mass index, symptom duration, diabetes, and preoperative electrophysiological severity on recovery will also be examined. No experimental drug, device, surgical technique, or additional treatment will be assigned as part of this study.
Carpal tunnel syndrome is the most common peripheral nerve entrapment neuropathy of the upper extremity and results from compression of the median nerve within the carpal tunnel. Patients may experience numbness, tingling, nocturnal paresthesia, pain, sensory loss, reduced grip strength, and, in advanced cases, thenar muscle weakness or atrophy. These impairments may negatively affect sleep, occupational performance, daily activities, and overall upper-extremity function.
Carpal tunnel release surgery aims to decompress the median nerve and is generally performed in patients who do not obtain adequate benefit from conservative treatment or who have progressive neurological or electrophysiological abnormalities. Although improvements in pain, paresthesia, and hand function are commonly observed after surgery, the rate and extent of recovery may vary between patients. Clinical improvement may also occur at a different rate from electrophysiological recovery of the median nerve.
This is a single-center, prospective observational cohort study involving adults with clinically and electrophysiologically confirmed carpal tunnel syndrome who are scheduled to undergo primary carpal tunnel release surgery as part of routine clinical care. The decision to perform surgery and the selection of the surgical technique will be made by the treating physician independently of participation in the study. Participation will not influence the surgical decision or the participant's routine treatment. No experimental intervention or additional treatment will be assigned by the investigators.
Only the surgically treated hand will be included in the analysis. For participants with bilateral carpal tunnel syndrome who undergo unilateral surgery during the study period, the operated hand will be evaluated. Two hands from the same participant will not be analyzed as independent observations.
Clinical and functional evaluations will be performed at baseline before surgery and at postoperative week 8. The evaluations will include the Boston Carpal Tunnel Questionnaire, Quick Disabilities of the Arm, Shoulder and Hand questionnaire, Numeric Rating Scale for pain, grip strength, pinch strength, Semmes-Weinstein monofilament testing, static two-point discrimination, and Tinel and Phalen tests.
Standard nerve conduction study findings obtained during routine clinical evaluation will be recorded at baseline and postoperative month 3. Electrophysiological variables will include median nerve distal motor latency, compound muscle action potential amplitude, sensory distal latency, sensory nerve action potential amplitude, and sensory nerve conduction velocity. Electrophysiological severity will be classified using the Bland neurophysiological grading scale. Needle electromyography will not be mandatory for study participation and will only be performed when clinically indicated as part of routine care.
The primary objective is to determine whether electrophysiological changes in the median nerve between baseline and postoperative month 6 are associated with changes in carpal tunnel symptoms and upper-extremity function. Particular emphasis will be placed on changes in distal motor latency and sensory nerve conduction velocity and their relationships with changes in the Boston Carpal Tunnel Questionnaire and QuickDASH scores.
Secondary analyses will examine the relationships between electrophysiological recovery and changes in pain severity, grip strength, pinch strength, monofilament sensation, and two-point discrimination. The study will also investigate whether demographic and clinical factors, including age, sex, body mass index, symptom duration, hand dominance, operated side, occupational hand use, diabetes mellitus, and preoperative electrophysiological severity, are associated with postoperative clinical, functional, or electrophysiological recovery.
The planned enrollment is approximately 70 to 100 participants. Findings from this study may help clarify the extent to which objective nerve conduction recovery reflects patient-reported and performance-based recovery after carpal tunnel release surgery.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 444 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Istanbul Medipol University Hospital is the lead sponsor of 367 studies on the registry; 47 are open to participants now.
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For participants with bilateral carpal tunnel syndrome who undergo unilateral surgery during the study period, only the operated hand will be included in the study. Two hands from the same participant will not be analyzed as independent observations.
Exclusion Criteria:
Participants with controlled diabetes mellitus will not be excluded solely because of diabetes. However, participants with electrophysiologically confirmed generalized polyneuropathy will be excluded. Diabetes status will be recorded and considered as a potential confounding variable in the analyses.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with clinically and electrophysiologically confirmed carpal tunnel syndrome who are scheduled to undergo primary carpal tunnel release surgery as part of routine clinical care will be included in this single study arm. The decision to perform surgery and the surgical technique will be determined by the treating physician independently of study participation. Clinical and functional assessments will be performed before surgery and at postoperative week 8. Median nerve conduction findings will be evaluated before surgery and at postoperative month 3. No experimental drug, device, surgical technique, or additional treatment will be administered as part of the study.
Procedure: Primary Carpal Tunnel Release Surgery
Participants will undergo primary carpal tunnel release surgery as part of their routine clinical care. The procedure aims to decompress the median nerve by releasing the transverse carpal ligament. The decision to perform surgery, the timing of surgery, and the surgical technique will be determined by the treating physician independently of study participation. The study will not require an experimental surgical technique or any modification of the participant's standard treatment. Participants will undergo clinical and functional follow-up assessments, and median nerve conduction findings will be evaluated before surgery and at postoperative month 6.
Change in Median Nerve Distal Motor Latency
Median nerve distal motor latency will be measured by a standardized nerve conduction study and recorded in milliseconds (ms). Change will be calculated as the postoperative month 6 value minus the preoperative value. A reduction in distal motor latency indicates electrophysiological improvement.
Time frame: Baseline and postoperative week 8
Change in Median Nerve Sensory Nerve Conduction Velocity
Median nerve sensory nerve conduction velocity will be measured by a standardized nerve conduction study and recorded in meters per second (m/s). Change will be calculated as the postoperative month 6 value minus the preoperative value. An increase in sensory nerve conduction velocity indicates electrophysiological improvement.
Time frame: Baseline and postoperative week 8
The Boston Carpal Tunnel Questionnaire consists of the Symptom Severity Scale and the Functional Status Scale. Each item is scored from 1 to 5, and the mean score is calculated separately for each subscale. Higher scores indicate greater symptom severity
The Boston Carpal Tunnel Questionnaire consists of the Symptom Severity Scale and the Functional Status Scale. Each item is scored from 1 to 5, and the mean score is calculated separately for each subscale. Higher scores indicate greater symptom severity or functional limitation. Change will be calculated relative to the baseline score. A reduction in score indicates clinical and functional improvement.
Time frame: Baseline, postoperative week 8
Change in Quick Disabilities of the Arm, Shoulder and Hand Score
Upper-extremity disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. The total score ranges from 0 to 100, with higher scores indicating greater disability. Change will be calculated relative to the baseline score. A reduction in score indicates improvement in upper-extremity function.
Time frame: Baseline, postoperative week 8
Change in Median Nerve Sensory Nerve Action Potential Amplitude
Description: Median nerve sensory nerve action potential amplitude will be measured by nerve conduction study and recorded in microvolts (µV). Change will be calculated as the postoperative month 3 value minus the baseline value. A higher amplitude generally indicates better sensory nerve function.
Time frame: Time Frame: Baseline and postoperative month 3
Change in Median Nerve Compound Muscle Action Potential Amplitude
Description: Median nerve compound muscle action potential amplitude will be measured by nerve conduction study and recorded in millivolts (mV). Change will be calculated as the postoperative month 3 value minus the baseline value. A higher amplitude generally indicates better motor nerve function.
Time frame: Time Frame: Baseline and postoperative month 3
Change in Numeric Rating Scale Pain Score
Description: Hand and wrist pain intensity will be evaluated using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. A reduction in score indicates improvement.
Time frame: Baseline, postoperative week 8, month 3,
Change in Semmes-Weinstein Monofilament Sensory Threshold
Description: Touch-pressure sensation will be evaluated using Semmes-Weinstein monofilaments at the thumb, index finger, and middle finger of the operated hand. The lowest monofilament level perceived at each location will be recorded. A lower sensory threshold indicates better touch-pressure sensitivity.
Time frame: Baseline, postoperative week 8, month 3,
Change in Static Two-Point Discrimination Distance
Description: Static two-point discrimination will be evaluated at the index and middle fingertips of the operated hand. The shortest distance at which two separate points can be distinguished will be recorded in millimeters (mm). A reduction in distance indicates improved sensory discrimination. Time Frame: Baseline, postoperative week 6, month 3,
Time frame: Time Frame: Baseline, postoperative week 8, month 3,
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Oct 2026, 1 month later.
Of 251 non-industry interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 1 month is below that.
Counting every sponsor, half of 261 studies reached it within 12 months; a quarter within 7 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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