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IRCT20221020056249N1 IRCT 2022-12-11 Shiraz University of Medical Sciences Comparison of day and night splints in patients with CTS(carpal tunnel syndrome) Comparison of the effectiveness of carpal tunnel injection of corticosteroids and night splints, with daily splints in patients with carpal tunnel syndrome according to changes in the degree of symptoms based on assessment forms and electrodiagnostic study 2022-12-04 anticipated 60 Complete https://irct.ir/trial/67166 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation method in this study will be permutation block method. A represents a person who receives corticosteroid injections and daily splints, and B represents a person who receives corticosteroid injections and nightly splints. This method is based on blocks of four so that the total number of possible permutations of four is equal to 6: BAAB ABBA , BBAA ،AABB ،BABA ،ABAB Then, by using the table of random numbers and assigning a code from 0 to 9 to each of the permutations, the desired random list of 60 which includes 15 blocks of 4 is generated (using a computer) and the order of assigning each of the methods to Each of the samples participating in the study It is determined. In order to hide ,the random sequence method is used by another person who is unaware of the research process , and the questionnaires are completed by a person who is unaware of the division of groups, Blinding description: Outcome assessor: Completed questionnaires and EDX findings are given to a person who is not aware of the interventions performed, and he is asked to rate the amount of pain reduction and increase in function and changes in nerve conduction velocity and latency according to the questionnaire and EDX findings. Data analyst: Finally, after completing and collecting all the information, the questionnaires are given to a person to check the information, who does not know about any of the work steps and how the intervention is divided. N/A Carpal Tunnel Syndrome. Intervention 1: Intervention group1: Injection of 40 mg of methylprednisolone is done in an area slightly proximal to the distal fold of the wrist between the palmaris longus and flexor carpi radialis tendons at the volar level of the wrist. Then a daily splint will be prescribed and also at the beginning of the study and after 6 weeks, the severity of symptoms will be determined based on the VAS and Boston questionnaires, and the subjects will be subjected to electrodiagnosis and the relevant information will be recorded. Intervention 2: Intervention group2: Injection of 40 mg of methylprednisolone is done in an area slightly proximal to the distal fold of the wrist between the palmaris longus and flexor carpi radialis tendons at the volar level of the wrist. Then a nightly splint will be prescribed and also at the beginning of the study and after 6 weeks, the severity of symptoms will be determined based on the VAS and Boston questionnaires, and the subjects will be subjected to electrodiagnosis and the relevant information will be recorded. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: Starting 6 months after publication To whom: Academic institutions Conditions: Practitoiners working in the same fields and who have CTS patients. Where to obtain: Shiraz medical science university How to obtain: By making a request to the university Comments:
public Forouzan Akbari
Shiraz Medical University of Science, Zand Ave., Shiraz Town.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3630 5123 Akbari.forouzan@gmail.com Shiraz University of Medical Sciences scientific Forouzan Akbari
Shiraz medical university,In front of Palestine St., Zand Ave., Shiraz Town.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 akbari.forouzan@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 25-64 y/o Patients diagnosed with mild to moderate CTS in electrodiagnostic study. 25 years 65 years Both Pregnancy Diabetes Melitus Hypothyroidism Inflammatory Arthropathy Rheumatoid Arthritis Polyneuropathy Alcoholism Infections Cervical disc pathologies History of past trauma or surgery G56.0 Carpal tunnel syndrome Treatment - Other Treatment - Other Intervention group1: Injection of 40 mg of methylprednisolone is done in an area slightly proximal to the distal fold of the wrist between the palmaris longus and flexor carpi radialis tendons at the volar level of the wrist. Then a daily splint will be prescribed and also at the beginning of the study and after 6 weeks, the severity of symptoms will be determined based on the VAS and Boston questionnaires, and the subjects will be subjected to electrodiagnosis and the relevant information will be recorded. Intervention group2: Injection of 40 mg of methylprednisolone is done in an area slightly proximal to the distal fold of the wrist between the palmaris longus and flexor carpi radialis tendons at the volar level of the wrist. Then a nightly splint will be prescribed and also at the beginning of the study and after 6 weeks, the severity of symptoms will be determined based on the VAS and Boston questionnaires, and the subjects will be subjected to electrodiagnosis and the relevant information will be recorded. VAS (visual analog scale) index for pain evaluation. Timepoint: At first and after 6 weeks of splint. Method of measurement: VAS questionaire. BCTSQ(Boston Carpal Tunnel Questionnaire) index for function evaluation. Timepoint: At first and after 6 weeks of splint. Method of measurement: Boston questionaire. NCV(nerve conduction velocity) and median nerve Latency in EDX( electrodiagnostic study). Timepoint: At first and after 6 weeks of splint. Method of measurement: Electrodiagnostic study. Shiraz University of Medical Sciences Approved 2022-10-08 Ethics committee of Shiraz University of Medical Sciences The central building of Shiraz University of Medical Sciences,across the Felestin Ave., Zand Ave.,Shiraz. Shiraz Fars Iran (Islamic Republic of)