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IRCT20180507039571N5 IRCT 2025-03-26 Esfahan University of Medical Sciences Comparison of the effect of hydrodissection combined with corticosteroids and open surgery in the treatment of moderate and severe carpal tunnel syndrome Comparison of the effect of hydrodissection combined with corticosteroids and open surgery in the treatment of moderate and severe carpal tunnel syndrome: A controlled clinical trial 2025-05-22 anticipated 40 Complete https://irct.ir/trial/82402 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Carpal tunnel syndrome. Intervention 1: Intervention group 1: Using an ultrasound device (ALPINION E-CUBE9 with 3-12 Mhz linear probe.ALPINION medical system.Seoul.South Korea), a hydrodissection injection of 5 cc of 5% dextrose water and 1 cc of triamcinolone is administered without local anesthesia using an inplane approach from the ulnar side to release the median nerve from the surrounding tissue. Intervention 2: Intervention group 2: Median nerve release surgery is performed with a 2.5 cm long incision 1.5 cm distal to the forearm along the fourth finger. 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 No more information available.
public Shervin Ghaffari Hoseini
Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, next to Shahid Chamran Heart Hospital, after Shahrestan Bridge, 3rd Mushtaq St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3611 5208 shghaffari@yahoo.com Esfahan University of Medical Sciences scientific Shervin Ghaffari Hoseini
Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, next to Shahid Chamran Heart Hospital, after Shahrestan Bridge, 3rd Mushtaq St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3611 5208 shghaffari@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with moderate to severe Carpal tunnel syndrome based on electrodiagnostic testing Age above 18 Male and female gender Not receiving carpal tunnel injection treatment and physiotherapy and modalities in the last three months 18 years no limit Both Radiculopathy Plexopathy Motor neuron disease Peripheral neuropathy pregnancy Hand and bone joint deformity History of hand trauma Having uncontrolled systemic diseases, such as inflammatory joint diseases and uncontrolled diabetes Suffering from thenar atrophy and severe weakness of the palm muscles G56.0 Carpal tunnel syndrome Treatment - Drugs Treatment - Surgery Intervention group 1: Using an ultrasound device (ALPINION E-CUBE9 with 3-12 Mhz linear probe.ALPINION medical system.Seoul.South Korea), a hydrodissection injection of 5 cc of 5% dextrose water and 1 cc of triamcinolone is administered without local anesthesia using an inplane approach from the ulnar side to release the median nerve from the surrounding tissue. Intervention group 2: Median nerve release surgery is performed with a 2.5 cm long incision 1.5 cm distal to the forearm along the fourth finger. Wrist pain score in carpal tunnel syndrome patients. Timepoint: Before the intervention and one, three, and six months after the completion of the intervention. Method of measurement: Using a visual analogue scale. Severity of dysfunction. Timepoint: Before the intervention and one, three, and six months after the completion of the intervention. Method of measurement: Using the Boston carpal tunnel questionnaire (BCTQ). Sensory and motor wave amplitude of the median nerve. Timepoint: Before and three months after the intervention. Method of measurement: Electrodiagnostic study. Median nerve sensory and motor wave latency. Timepoint: Before and three months after the intervention. Method of measurement: Electrodiagnostic study. Esfahan University of Medical Sciences Approved 2025-03-10 Ethical Committee of school of medicine, Isfahan University of Medical Sciences Vice President for Research and Technology, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib Street Isfahan Isfehan Iran (Islamic Republic of)