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IRCT20200705048007N1 IRCT 2021-03-23 Shiraz University of Medical Sciences Effect of Dextrose 5% in Water (D5W) injection in carpal tunnel syndrome Comparison of the effectiveness of ultrasound-guided injection of Dextrose 5% in Water (D5W) and Corticostroid in patients with carpal tunnel syndrome 2021-04-21 anticipated 42 Complete https://irct.ir/trial/49452 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used. Blocking is usually used to balance the number of samples assigned to each of the study groups. The size of all blocks is equal and, in this study, we will have blocks length of 4, including 2 patients in the dextrose group and 2 patients in the methyl group. Randomization is done by computer using Random allocation software version 1.0.0. For concealment, we use random allocation concealment using opaque sealed and sequentially numbered envelopes, so that the assigned group is not known before the individual is assigned. In this method, each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. In order to maintain the random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the envelopes are glued and placed in a box, respectively. Based on the order of entry of eligible patients into the study, one of the envelopes is opened in order and their assigned group is revealed, Blinding description: At the time of patients enrollment and taking informed consent, they are told that they will be injected with one of the drugs methylprednisolone or 5% dextrose. For injection, covered syringes with same shape and size whose contents are not visible are used, and thus patients do not know the exact type of medication to be injected. The physician who performs injections knows the type of medication based on the patient`s code. A person who fills out severity and function questionnaires, as well as a person who measures the criteria for electrodiagnosis and ultrasound during follow up sessions, are not aware of the type of medication for each person, Because just the name and code of each person will be written on the data collection forms and the type of intervention will not be mentioned. The statistical consultant who will analyze the final data does not know what drug has been injected for each group and the groups data will be given to him under the pseudonyms A and B. 2-3 carpal tunnel syndrome. Intervention 1: Intervention group: Only once, under ultrasound guidance, 2 cc 5% dextrose product of Shiraz Serum Pharmaceutical Company is injected through a needle gauge 23 into the carpal tunnel area (into the scaphoid and pisiform bones plate). Intervention 2: Intervention group: Only once, under ultrasound guidance, 40 mg(1 cc) methylprednisolone acetate product of Exir Pharmaceutical Company with 1 cc normal saline product of Darou Pakhsh Factory is injected through a needle gauge 23 into the carpal tunnel area (into the scaphoid and pisiform bones plate). Yes - There is a plan to make this available What will be shared: Demographic information file, all potential data after unidentifiable individuals,including main outcome. When: Access period starts 6 months after publishing the results. To whom: Researchers working in academic and scientific institutions Conditions: Use of data and documents in parts of articles such as: Review of the background of the subject, Analysis and conclusion and also in Review and meta-analysis studies is allowed. Where to obtain: Correspondence with the main researcher, Farzaneh Rezaei Motlagh with e-mail address: farzaneh.rm7@gmail.com How to obtain: Sending an e-mail requesting the receipt of documents, along with providing evidence of the academic position of the person related to the research topic, stating the purpose of the request for documentation.this e-mail will be answered within a maximum of one month. Comments:
public Farzaneh Rezaei motlagh
No.11, Hamoon2 building, 4.8 Alley, Shahid Abaeian Ave., Neshat Street
shiraz Iran (Islamic Republic of) 7134867425 +98 71 3231 9672 farzaneh.rm7@gmail.com Shiraz University of Medical Sciences scientific Farzaneh Rezaei motlagh
No.11, Hamoon2 building, 4.8 Alley, Shahid Abaeian Ave., Neshat Street
shiraz Iran (Islamic Republic of) 7134867425 +98 71 3231 9672 farzaneh.rm7@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Completing and signing the conscious consent form Age between 30 and 65 years Mild to moderate Carpal tunnel syndrome , based on electrodiagnostic criteria Paresthesia or dysesthesia or pain in the hand and wrist (which is associated with a particular condition, excessive use of the hand or the occurrence at night or relieved by shaking the hand) Existence of one of the following in the physical examination: positive Phalen test, positive Tinel test, weakness in the thenar muscles, sensory defects in the sensory area of the Median nerve in the hand It has been at least 3 months since the onset of symptoms and has not responded to non-invasive treatments 30 years 65 years Both Positive history of polyneuropathy Positive history of surgery on involved wrist History of previous steroid injections into the affected wrist over the past year History of rheumatological diseases such as rheumatoid arthritis Pregnancy Neoplasm in involved wrist History of allergy to steroids Infection at the injection site Coagulopathies and bleeding tendency Positive history of brachial plexopathy Positive history of thoracic outlet syndrome Positive history of active radiculopathy G56.0 Carpal tunnel syndrome Treatment - Other Treatment - Other Intervention group: Only once, under ultrasound guidance, 2 cc 5% dextrose product of Shiraz Serum Pharmaceutical Company is injected through a needle gauge 23 into the carpal tunnel area (into the scaphoid and pisiform bones plate). Intervention group: Only once, under ultrasound guidance, 40 mg(1 cc) methylprednisolone acetate product of Exir Pharmaceutical Company with 1 cc normal saline product of Darou Pakhsh Factory is injected through a needle gauge 23 into the carpal tunnel area (into the scaphoid and pisiform bones plate). Cross sectional area of median nerve. Timepoint: At the beginning of the study (before the intervention) , 1 and 3 months after the intervention (injection). Method of measurement: manual by sonography. Median sensory nerve action potentials amplitude. Timepoint: At the beginning of the study (before the intervention) , 1 and 3 months after the intervention (injection). Method of measurement: electromyography. Median sensory nerve action potentials latency. Timepoint: At the beginning of the study (before the intervention) , 1 and 3 months after the intervention (injection). Method of measurement: electromyography. Median compound motor action potentials latency. Timepoint: At the beginning of the study (before the intervention) , 1 and 3 months after the intervention (injection). Method of measurement: electromyography. Median compound muscle action potentials amplitude. Timepoint: At the beginning of the study (before the intervention) , 1 and 3 months after the intervention (injection). Method of measurement: electromyography. Pain score by visual analogue scale. Timepoint: At the beginning of the study (before the intervention) , 1 and 3 months after the intervention (injection). Method of measurement: visual analogue scale. Severity score by Boston carpal tunnel syndrome questionnaire. Timepoint: At the beginning of the study (before the intervention) , 1 and 3 months after the intervention (injection). Method of measurement: Boston carpal tunnel syndrome questionnaire. Functional score by Boston carpal tunnel syndrome questionnaire. Timepoint: At the beginning of the study (before the intervention) , 1 and 3 months. Method of measurement: Boston carpal tunnel syndrome questionnaire. Shiraz University of Medical Sciences Approved 2019-08-17 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Karimkhan Zand Boulvard Shiraz Fars Iran (Islamic Republic of)