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IRCT20170311033000N6 IRCT 2026-06-03 Shahid Beheshti University of Medical Sciences study of the efficacy of Neurobion in the treatment of carpal tunnel syndrome A comparative study of the efficacy of Neurobion and corticosteroid injections under ultrasound guidance in the treatment of carpal tunnel syndrome 2026-05-23 anticipated 44 Recruiting https://irct.ir/trial/89894 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated to the two treatment groups using simple randomization with a 1:1 allocation ratio. For this purpose, a numbered list will first be prepared for the 44 participants. Then, using the RAND function in Microsoft Excel, a random number will be generated for each participant. Based on the sorted random numbers, patients will be randomly assigned into two groups of 22 participants receiving either Neurobion or corticosteroid injection. The allocation sequence will be maintained by a person not involved in the outcome assessment process and will be placed in opaque, sequentially numbered sealed envelopes to ensure allocation concealment, Blinding description: Patients were unaware of the type of medication administered, as the syringes were prepared by an independent individual and were identical in appearance and the injection volume was equal in both groups. The data analyst received the data set labeled only as Group A and Group B, and the allocation code was revealed only after completion of the statistical analysis and documentation of the results. Thus, neither the participants nor the data analyst were aware pf the type of intervention adminstered. 3 Carpal tunnel syndrome. Intervention 1: Intervention Group 1: Corticosteroid injection (1 mL methylprednisolone 40 mg/mL + 1 mL Lidocaine) plus wrist splint with 5° extension. Intervention 2: Intervention Group 2: Injection of 1.5 mL Octobion + 0.5 mL Lidocaine plus a wrist splint positioned at 5° of extension. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Masumeh Bayat
Mahdieh Hospital, Tehran
tehran Iran (Islamic Republic of) ۱۱۸۵۸۱۷۳۱۱ +98 21 5506 2628 bayat.masyme@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Masume Bayat
Mahdieh Hospital, Shishegar Alley, Fadaeean Islam Ave., Shoush square, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۱۸۵۸۱۷۳۱۱ +98 21 5506 2628 bayat.masyme@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) People with a median nerve SNAP peak latency greater than 3.6 People with a median nerve CMAP onset latency greater than or equal to 4.2 20 years 65 years Both Pregnancy Metabolic disease such as ( Diabetes, Thyroid, RA, ...) Croticosteroid injection within the past three months Thenar atrophy CTS surgery Neuropathy or Radiculopathy Malignancy Treatment - Drugs Treatment - Drugs Intervention Group 1: Corticosteroid injection (1 mL methylprednisolone 40 mg/mL + 1 mL Lidocaine) plus wrist splint with 5° extension. Intervention Group 2: Injection of 1.5 mL Octobion + 0.5 mL Lidocaine plus a wrist splint positioned at 5° of extension. Peak Latency, Onset Latency. Timepoint: before injection. Method of measurement: Electromyography nerve conduction study. Pain Score. Timepoint: before injection. Method of measurement: Visual Analogue Scale questionnaire. Symptom Severity and Hands Function. Timepoint: before injection. Method of measurement: Boston Carpal Tunnel Questionnaire. َAmplitude of Sensory Nerve Action Potential and Compound Motor Action Potential. Timepoint: before injection. Method of measurement: Electromyography nerve conduction study. Peak Latency, Onset Latency. Timepoint: 3 months after injection. Method of measurement: Electromyography nerve conduction study. Pain Score. Timepoint: 3 months after injection. Method of measurement: Visual Analogue Scale questionnaire. Symptom Severity and Hands Function. Timepoint: 3 months after injection. Method of measurement: Boston Carpal Tunnel Questionnaire. َAmplitude of Sensory Nerve Action Potential and Compound Motor Action Potential. Timepoint: 3 months after injection. Method of measurement: Electromyography nerve conduction study. Shahid Beheshti University of Medical Sciences Approved 2026-02-01 Ethics committee of Shahid Beheshti University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)