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IRCT20250722066599N1 IRCT 2025-10-24 Islamic Azad University Comparison of two Surgical Techniques for Carpal Tunnel Syndrome : Standard vs. Advanced Procedures Comparison of Carpal Tunnel Release Surgery with Hypothenar fat Pad Flap for the Treatment of Carpal Tunnel Syndrome 2025-10-23 anticipated 40 Complete https://irct.ir/trial/85129 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting 40 eligible patients based on the inclusion criteria, each patient was assigned a unique identification number. For randomization, a random number table was prepared, and patients were reviewed one by one according to their identification numbers. Using the numbers drawn from the table, each patient was randomly assigned to one of the two groups (CTR or CTR+HFPF). This procedure was carried out by an individual independent of the treatment team to ensure allocation concealment and to prevent any selection bias. All assigned numbers and the order of assignment were recorded and preserved, allowing verification that the allocation was indeed random by a knowledgeable observer. Although statistical software or online randomization tools could have been used, in this study, a manual and traceable random number table method was applied, Blinding description: In this study, due to the surgical nature of the wrist intervention, patients and surgeons were not blinded and therefore were aware of the treatment group. However, to minimize bias, the following measures were implemented: 1. Clinical assessments and data collection were performed by an independent evaluator who was unaware of patients’ group allocation. 2. Statistical analyses were conducted by an independent analyst blinded to the treatment assignment. 3. Patients completed the Boston questionnaires without knowledge of the specific aim of the treatment comparison, reducing expectancy effects. Therefore, the study was single-blind: the clinical evaluator and the data analyst were blinded, but patients and surgeons were not. Answer for the questionnaire about who was blinded: Patients: No Surgeons: No Clinical evaluator: Yes Data analyst: Yes. N/A Carpal Tunnel Syndrome. Intervention 1: Conventional Carpal Tunnel Release (CTR): Patients assigned to this group will undergo standard open carpal tunnel release surgery. Under local anesthesia and sterile conditions, a longitudinal incision (approximately 3–4 cm) will be made along the radial border of the ring finger at the base of the palm. The subcutaneous tissues and palmar fascia will be carefully dissected to expose the transverse carpal ligament, which will then be completely divided to decompress the median nerve. Hemostasis will be achieved, and the wound will be closed with interrupted nylon sutures. Intervention 2: Carpal Tunnel Release with Hypothenar Fat Pad Flap (HFPF): After standard carpal tunnel release, a vascularized adipose flap will be prepared from the hypothenar eminence. The flap will be based on ulnar artery perforators and will be elevated carefully to preserve its vascular supply. It will then be rotated and placed over the median nerve to provide a soft-tissue cushion that prevents postoperative adhesion and promotes nerve healing. The flap will be fixed in place with absorbable sutures, and the skin will be closed in layers. Yes - There is a plan to make this available What will be shared: In case of a request from the ethics committee, the data will be provided in Excel file format. When: Starting from January 2026 To whom: Ethics Committee, Reviewers, and Supervising Professors Conditions: In case of a request from the ethics committee, the data will be provided in Excel file format. Where to obtain: Supervisor and Principal Investigator How to obtain: In the event of an official request for access to study data or documentation, the process is as follows: the request must be submitted in writing by the relevant authority (such as the Ethics Committee or research institutions), clearly stating the purpose. The research team will then review the request, and upon approval, the data will be provided in a structured format (such as Excel or PDF), ensuring confidentiality and adherence to ethical research standards. Comments:
public saeed enayati
hesabi avenue
shahrood Iran (Islamic Republic of) 7157759318 +98 71 3740 8566 mohammad.dutty@gmail.com Shahroud University of Medical Sciences scientific saeed enayati
hesabi avenue
shahrood Iran (Islamic Republic of) 7157759318 +98 71 3740 8566 mohammad.dutty@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of Carpal Tunnel Syndrome (CTS) based on clinical and electrodiagnostic criteria.Definition of Carpal Tunnel Syndrome (CTS):CTS is a compressive neuropathy caused by compression of the median nerve within the carpal tunnel of the wrist, presenting with sensory and motor symptoms in the hand. Diagnosis is based on a combination of clinical findings and electrodiagnostic confirmation. Age ≥ 18 years. Age<65 years Informed consent for participation in the study. Presence of clinical symptoms such as numbness, tingling, or weakness in the affected hand. 18 years 65 years Both History of wrist surgery or nerve reconstruction in the affected hand. Systemic diseases that may mimic CTS symptoms (e.g., uncontrolled diabetes, thyroid disorders). Recent hand or wrist injury within the past 6 months. Use of medications affecting peripheral nerves. G56.00 Carpal tunnel syndrome, unspecified upper limb Treatment - Surgery Treatment - Surgery Conventional Carpal Tunnel Release (CTR): Patients assigned to this group will undergo standard open carpal tunnel release surgery. Under local anesthesia and sterile conditions, a longitudinal incision (approximately 3–4 cm) will be made along the radial border of the ring finger at the base of the palm. The subcutaneous tissues and palmar fascia will be carefully dissected to expose the transverse carpal ligament, which will then be completely divided to decompress the median nerve. Hemostasis will be achieved, and the wound will be closed with interrupted nylon sutures. Carpal Tunnel Release with Hypothenar Fat Pad Flap (HFPF): After standard carpal tunnel release, a vascularized adipose flap will be prepared from the hypothenar eminence. The flap will be based on ulnar artery perforators and will be elevated carefully to preserve its vascular supply. It will then be rotated and placed over the median nerve to provide a soft-tissue cushion that prevents postoperative adhesion and promotes nerve healing. The flap will be fixed in place with absorbable sutures, and the skin will be closed in layers. Improvement in symptom severity and functional status : based on the Boston Carpal Tunnel Questionnaire (BCTQ). This outcome evaluates the degree of symptom relief (such as numbness, tingling, nocturnal pain, and hand weakness) and the patient’s ability to perform daily tasks (such as writing, buttoning, and holding objects). The BCTQ provides a validated and quantitative assessment of both symptom severity (SSS) and functional status (FSS). Timepoint: 4, 8, and 12 weeks after intervention. Method of measurement: Using the BCTQ, which includes 19 questions divided into two subscales (SSS and FSS). Each item is rated on a 5-point Likert scale, and lower scores indicate better symptom control and hand function. Reduction in pain : intensity as an indicator of symptomatic improvement following surgery. Pain relief is a key determinant of patient satisfaction and surgical success in carpal tunnel syndrome management. Timepoint: 2, 4, 8, and 12 weeks after intervention. Method of measurement: Using the Visual Analog Scale (VAS), where patients mark their pain intensity on a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Improvement in sensory function of the hand . Restoration of sensory discrimination is essential for hand dexterity and fine motor control. Timepoint: 2, 4, 8, and 12 weeks after intervention. Method of measurement: Assessed using the Two-Point Discrimination (2PD) test with a calibrated caliper. The minimum distance (in millimeters) at which the patient can distinguish two separate points is recorded. Improvement in neurological clinical tests , including Phalen and Tinel tests, reflecting recovery of median nerve function. Timepoint: 2, 4, 8, and 12 weeks after intervention. Method of measurement: Clinical assessment performed by the investigator; results documented as positive or negative for each test. Increase in hand muscle strength , including grip and pinch strength, as an indicator of motor recovery and functional improvement. Timepoint: 2, 4, 8, and 12 weeks after intervention. Method of measurement: Measured using a hand dynamometer (in kilograms) for grip strength and a pinch gauge for pinch strength. Higher readings indicate better motor recovery. Islamic Azad University Approved 2023-12-29 Ethics committee of islamic azad University of shahrood hesabi avenue shahrood Semnan Iran (Islamic Republic of)