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IRCT20200219046552N1 IRCT 2020-03-29 Rasht University of Medical Sciences Comparison of local corticosteroid injection and high-intensity laser outcomes in moderate carpal tunnel syndrome (CTS) Comparison of local corticosteroid injection and high-intensity laser outcomes in moderate carpal tunnel syndrome (CTS) 2020-04-20 anticipated 126 Complete https://irct.ir/trial/46465 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly divided into 42 groups in each group and 126 in the Random Allocation software. The format will be in a sealed envelope at the Neuroscience Research Center under the supervision of the inspector. On a daily basis, patients will be studied in groups. N/A Carpal tunnel syndrome. Intervention 1: Control group: The splint will be prescribed with painkillers (meloxicam 15 mg) and vitamin B1. The splint should be used in neutral position for at least 8 hours a day for 3 months (night and during activity) and painkillers and Vitamin B1 will be taken daily for 6 weeks. Intervention 2: First intervention group: 40 mg of methylprednisolone (depromedrol) in combination with 1% lidocaine will be injected with a 23G needle so that the needle will be placed on the inner side of the Palmaris longus tendon in the distal palmar groove at an angle of 45 ° to the forearm. Intervention 3: Second intervention group: In order to perform laser therapy, the patient is cleaned in a supine position with a cotton swab. It will then be irradiated as much as 4 x 5 cm around the nerve and the laser scanner will be illuminated from a distance of 10 cm. The laser therapy time for each area will be 167 seconds. It should be noted that the laser rotation will be zero, 60% Duty cycle and 100 Hz frequency. Each patient will undergo laser therapy for 3 sessions, one day in between. Yes - There is a plan to make this available What will be shared: A portion of the study participants' personal data, including demographic data and study outcomes, will be shared after unidentifiable individuals. When: The access period will start 3 months after printing. To whom: Researchers working in universities. Conditions: Researchers working in universities. Where to obtain: Address: Poursina Hospital, Namjoo st., Rasht How to obtain: A written request for data from the relevant university with the name and academic degree of the researcher Comments:
public Mozaffar Hosseininezhad
Namjoo st., Poursina Hospital
Rasht Iran (Islamic Republic of) 41937-13194 +98 13 3332 2444 hosseininezhadm@gmail.com Rasht University of Medical Sciences scientific Mozaffar Hosseininezhad
Namjoo st., Poursina Hospital
Rasht Iran (Islamic Republic of) 41937-13194 +98 13 3332 2444 hosseininezhadm@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with unilateral or bilateral CTS according to Median Nerve Electrophysiology (EMG-NCV) studies will be enrolled. no limit no limit Both History of wrist surgery, polyneuropathy, brachial plexopathy or thoracic outlet syndrome History of thrombocytopenia, platelet disorder, systemic infection, pregnancy and rheumatologic disorders. Previous injection of cortisone for treatment of CTS Thenar muscle atrophy G56.0 Carpal tunnel syndrome Treatment - Devices Treatment - Drugs Treatment - Devices Control group: The splint will be prescribed with painkillers (meloxicam 15 mg) and vitamin B1. The splint should be used in neutral position for at least 8 hours a day for 3 months (night and during activity) and painkillers and Vitamin B1 will be taken daily for 6 weeks. First intervention group: 40 mg of methylprednisolone (depromedrol) in combination with 1% lidocaine will be injected with a 23G needle so that the needle will be placed on the inner side of the Palmaris longus tendon in the distal palmar groove at an angle of 45 ° to the forearm. Second intervention group: In order to perform laser therapy, the patient is cleaned in a supine position with a cotton swab. It will then be irradiated as much as 4 x 5 cm around the nerve and the laser scanner will be illuminated from a distance of 10 cm. The laser therapy time for each area will be 167 seconds. It should be noted that the laser rotation will be zero, 60% Duty cycle and 100 Hz frequency. Each patient will undergo laser therapy for 3 sessions, one day in between. Symptom severity scale in Boston Carpal Tunnel Syndrome Questionnaire. Timepoint: Measurement of symptom severity at baseline and 6 months later. Method of measurement: Boston Carpal Tunnel Syndrome Questionnaire. Functional status scale in Boston Carpal Tunnel Syndrome Questionnaire. Timepoint: Measurement of functional status at baseline and 6 months later. Method of measurement: Boston Carpal Tunnel Syndrome Questionnaire. Severity of pain. Timepoint: At baseline and 6 months after intervention. Method of measurement: Visual analog scale. Distal sensory latency. Timepoint: At baseline and 6 months after intervention. Method of measurement: Based on the amount recorded by the EMG-NCV device. Distal motor latency. Timepoint: At baseline and 6 months after intervention. Method of measurement: Based on the amount recorded by the EMG-NCV device. Medical complications. Timepoint: 6 months after intervention. Method of measurement: Based on individual response. Rasht University of Medical Sciences Approved 2019-12-21 Ethics committee of Guilan University of Medical Sciences Namjoo st., Poursina Hospital Rasht Guilan Iran (Islamic Republic of)