Electrophysiological and Functional Recovery After Carpal Tunnel Release

NCT07803939 | Not Yet Recruiting

• 1 other identifier: IMU-CTS-2026-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Carpal Tunnel Release; Median Nerve; Electrophysiological Recovery; Hand Function; QuickDASH

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and postoperative week 8

Secondary Outcomes (8)

• Change in Median Nerve Sensory Nerve Conduction Velocity

  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

  Baseline, postoperative week 8

• Change in Quick Disabilities of the Arm, Shoulder and Hand Score

  Baseline, postoperative week 8

• Change in Median Nerve Sensory Nerve Action Potential Amplitude

  Time Frame: Baseline and postoperative month 3

• Change in Median Nerve Compound Muscle Action Potential Amplitude

  Time Frame: Baseline and postoperative month 3

Study Arms (1)

Carpal Tunnel Release Group

OTHER

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

Interventions

Primary Carpal Tunnel Release Surgery PROCEDURE

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.

Carpal Tunnel Release Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years.
• Clinical and electrophysiological diagnosis of carpal tunnel syndrome.
• Scheduled to undergo primary carpal tunnel release surgery based on routine clinical evaluation.
• Availability of a preoperative nerve conduction study.
• Ability to understand and complete the study assessments and questionnaires.
• Ability to read and understand Turkish.
• Willingness to participate and provide written informed consent.
• Ability and willingness to attend the planned postoperative follow-up assessments.
• 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.

You may not qualify if:

• Previous carpal tunnel release surgery on the study hand.
• Planned revision carpal tunnel surgery.
• Electrophysiological evidence of generalized polyneuropathy.
• Another peripheral neuropathy affecting the median nerve or function of the study hand.
• Active cervical radiculopathy or brachial plexopathy.
• A central or peripheral neurological disorder that substantially affects upper-extremity function.
• History of major trauma or surgery involving the study hand or wrist that may affect outcome assessments.
• Active inflammatory rheumatologic disease.
• Pregnancy.
• Uncontrolled systemic disease that may interfere with surgery, assessment, or follow-up.
• Cognitive or communication impairment that prevents completion of the study assessments.
• Inability to complete the planned postoperative follow-up assessments.
• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is planned because all participants will undergo primary carpal tunnel release surgery and the study outcomes include clinical, functional, and electrophysiological assessments.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective, single-group study of adults undergoing primary carpal tunnel release surgery. All participants will receive carpal tunnel release as part of their routine clinical care and will be followed from the preoperative period through postoperative month 6. Clinical and functional assessments will be performed at baseline, postoperative week 6, month 3, and month 6. Nerve conduction findings will be evaluated at baseline and postoperative month 6. No experimental drug, device, surgical technique, or additional treatment will be assigned by the study.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share