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IRCT20220929056056N1 IRCT 2022-12-26 Shiraz University of Medical Sciences Comparative effectiveness of ultra-sound guided injections of corticosteroid and perineural dextrose 5% in patients with cubital tunnel syndrome Comparative effectiveness of ultra-sound guided injections of corticosteroid and perineural dextrose 5% on clinical appearance, function, sonographic and electrodiagnostic findings in patients with cubital tunnel syndrome, a clinical trial study 2023-01-20 anticipated 22 Complete https://irct.ir/trial/66117 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated in to two groups by Block Randomization Assignment and Double blind methods. We will have two lists of 11 patients, including the two intervention and control groups, at random. For concealment, method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by a person unaware of the division of groups, Blinding description: Participant: in this study, we does not have the ability to blind the participant because the participant is aware of receiving each intervention. Clinical care giver: we teach the caregiver how to complete the questionnaire. This person is not aware of receiving patient’s intervention. Researcher: this study does not have the ability to blind the researcher due to performing both interventions by himself and being aware of receiving the kind of intervention in each group. The outcome assessor of the complete questionnaires is given to a person who is not aware of the intervention performed and he/she is asked to determine the level of performance in each person according to the questionnaires. Data analyzer: questionnaire are finally given to a person to review the information. This person does not know any of the steps of the work and the way of classification in which the intervention performed. 2 Cubital tunnel syndrome. Intervention 1: First Intervention group: The patients will be placed in a supine position with the shoulder abducted and the elbow flexed at 90°.The ulnar nerve within the cubital tunnel will be identified in transverse plane, and the injection will be conducted after aseptic preparation. Patients will receive locally 1 ml Methyl Prednisolone Acetate 40 mg and 1 ml Normal saline plus 1 ml Lidocaine 2%, in one session. The patients have to complete the Visual Analog Scale and PRUNE questionnaires before entering the study and 3 and 12 weeks after intervention. Electrodiagnostic and sonographic findings will be evaluated before intervention and 12 weeks later. Intervention 2: Second Intervention group: The patients will be placed in a supine position with the shoulder abducted and the elbow flexed at 90°.The ulnar nerve within the cubital tunnel will be identified in transverse plane, and the injection will be conducted after aseptic preparation. Patients will receive locally 2 ml D5W plus 1 ml Lidocaine 2%, in one session. The patients have to complete the Visual Analog Scale and PRUNE questionnaires before entering the study and 3 and 12 weeks after intervention. Electrodiagnostic and sonographic findings will be evaluated before intervention and 12 weeks later. Yes - There is a plan to make this available What will be shared: All available data can be shared after making people unidentifiable. When: Start access period one year after publishing the results. To whom: Everyone can access to this information. Conditions: If the information in this study helps to improve the science process. Where to obtain: Dr. Maryam Mirhadi, 00989177398937, maryam.mirhadii@gmail.com How to obtain: After sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of three weeks if permitted. Comments:
public Maryam Mirhadi
No 5, Yas building, 6 Alley, Ahmad Abad Square, Farhangian Town
Shiraz Iran (Islamic Republic of) 7179871123 +98 71 3845 4837 maryam.mirhadii@gmail.com Shiraz University of Medical Sciences scientific Maryam Mirhadi
No 5, Yas building, 6 Alley, Ahmad Abad Square, Farhangian Town
Shiraz Iran (Islamic Republic of) 7179871123 +98 71 3845 4837 maryam.mirhadii@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Mild to moderate ulnar nerve entrapment Age of 20-65 years At least 1 month persistence of symptoms and signs 20 years 65 years Both Severe condition Brachial plexus neuropathy History of elbow trauma or operation Rheumatologic disorder Peripheral neuropathy Previous perineural injection Malignancy Coagulopathy Pregnancy Active infection or infection of injection site G56.20 Lesion of ulnar nerve, unspecified upper limb Rehabilitation Rehabilitation First Intervention group: The patients will be placed in a supine position with the shoulder abducted and the elbow flexed at 90°.The ulnar nerve within the cubital tunnel will be identified in transverse plane, and the injection will be conducted after aseptic preparation. Patients will receive locally 1 ml Methyl Prednisolone Acetate 40 mg and 1 ml Normal saline plus 1 ml Lidocaine 2%, in one session. The patients have to complete the Visual Analog Scale and PRUNE questionnaires before entering the study and 3 and 12 weeks after intervention. Electrodiagnostic and sonographic findings will be evaluated before intervention and 12 weeks later. Second Intervention group: The patients will be placed in a supine position with the shoulder abducted and the elbow flexed at 90°.The ulnar nerve within the cubital tunnel will be identified in transverse plane, and the injection will be conducted after aseptic preparation. Patients will receive locally 2 ml D5W plus 1 ml Lidocaine 2%, in one session. The patients have to complete the Visual Analog Scale and PRUNE questionnaires before entering the study and 3 and 12 weeks after intervention. Electrodiagnostic and sonographic findings will be evaluated before intervention and 12 weeks later. Upper limb pain. Timepoint: Before intervention, three weeks and twelve weeks later. Method of measurement: Visual Analogue Scale, PRUNE questionnaire. Sensory and Motor symptoms. Timepoint: Before intervention, three weeks and twelve weeks later. Method of measurement: PRUNE questionnaire. Function of patient. Timepoint: Before intervention, three weeks and twelve weeks later. Method of measurement: PRUNE questionnaire. Cross-sectional area of ulnar nerve. Timepoint: Before intervention and twelve weeks later. Method of measurement: Ultrasonography. Shiraz University of Medical Sciences Approved 2022-09-19 Ethics committee of Shiraz University of Medical Sciences No 5, Yas building, 6 Alley, Ahmad Abad Square, Farhangian Town Shiraz Fars Iran (Islamic Republic of)