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IRCT20201013049018N1 IRCT 2021-04-07 Shiraz University of Medical Sciences "The effectiveness of dextrose prolotherapy in knee osteoarthritis"; "The effectiveness of genicular nerve block in knee osteoarthritis" The comparison of the effectiveness of dextrose prolotherapy vs. genicular nerve block in reducing pain and improving function in patients with knee osteoarthritis 2021-05-20 anticipated 30 Complete https://irct.ir/trial/51683 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To match patients in the control and treatment groups, patients are randomly assigned to one of two treatment groups. The random allocation method in this study will be the permutation block randomization method, such that "A" represents the subject receiving the prolotherapy method, and "B" represents the subject who receives the genicular nerve block. This method is based on 15 blocks in 4 permutations, taking into account all possible quadruple permutations (AABB, ABAB, ABBA, BAAB, BBAA and BABA) and assigning zero to nine (according to a random number table) to each of these permutations (i.e. AABB Code 0, BABA Code 1, AABB Code 2, BBAA Code 3, BAAB Code 4, and ABBA Code 5 to 9). The method of using random table is that the 15 numbers from zero to nine (rows or columns) are randomly selected, and the assigned permutations to each number are written. (The order of placing permutations next to each other is left to right respectively) and how all 60 people will be assigned to two groups A and B, and so we will have two lists of 30 patients, including the two intervention and control groups, at random. For concealment, this method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by this person unaware of the division of groups, Blinding description: Participant: At this study, we are not able to blind the patient, because patients of both groups are aware of the type of the intervention. Clinical caregiver: The caregiver is trained to complete the questionnaire and has no knowledge of the type of patient intervention. Researcher: at this study, we do not have the ability to blind the researcher, because the researcher does both studies himself and is aware of the type of intervention in each group. The impact assessor: Completed questionnaires are given to a person who is not aware of the interventions performed and he/she is asked to determine the amount of pain reduction and functional increasement in each person according to the questionnaire. Data analyzer: The questionnaires are finally given to a person to review the information after completing and collecting all the information. This person does not know any of the steps of the work and how to divide the intervention. N/A Knee Osteoarthritis; Dextrose Prolotherapy; Genicular Nerve Block. Intervention 1: Intervention group: The group undergoing the block of three branches of the genicular sensory nerves (supramedial, supralateral and inframedial branches) in one session (common technique), using 1 cc of Razi company 70% alcohol under the guidance of ultrasound or fluoroscope and correcting lifestyle and doing proper knee exercises. Intervention 2: Control group: The group undergoing prolotherapy with Shahid Ghazi company 25% dextrose intraarticularly by needle (gauge 22) in 3 stages (one week apart) according to the usual protocol with the recommendation to follow the correct lifestyle and perform appropriate knee exercises. 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. Mohammad Esmaeil ghorbani nejad 00989164168766 m_ghorbani1990@yahoo.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 the three weeks if permitted. Comments:
public Mohammad Esmaeil Ghorbani Nejad
No. 82, Sepideh Tower, Baneshi Street, Parastar Blvd., Ehsan Square
Shiraz Iran (Islamic Republic of) 7184876856 +98 71 3639 6445 m_ghorbani1990@yahoo.com Shiraz University of Medical Sciences scientific Mohammad Esmaeil Ghorbani Nejad
No. 82, Sepideh Tower, Baneshi Street, Parastar Blvd., Ehsan Square
Shiraz Iran (Islamic Republic of) 7184876856 +98 71 3639 6445 m_ghorbani1990@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Existence of pain and other clinical signs of knee osteoarthritis and pain with a VAS score of at least 4 due to knee osteoarthritis during last month Age between 45 to 70 years old Absence of any periarticular disease around the target joint 45 years 70 years Both Diabetes Mellitus Rheumatologically and collagen vascular disorders (eg; gout and lupus) Radiculopathy Nerve injuries and neuropathy Brucellosis BMI more than 42 Knee replacement on the affected side History of trauma and joint fracture Severe deformity of the lower extremities Bleeding disorders Inability to communicate History of allergic reactions to the used drugs History of intraarticular or periarticular injections at the affected joint in the last 3 months History of significant liver, kidney and cardiopulmonary disorders Pregnancy Malignancy Use of anticoagulants Rehabilitation Rehabilitation Intervention group: The group undergoing the block of three branches of the genicular sensory nerves (supramedial, supralateral and inframedial branches) in one session (common technique), using 1 cc of Razi company 70% alcohol under the guidance of ultrasound or fluoroscope and correcting lifestyle and doing proper knee exercises Control group: The group undergoing prolotherapy with Shahid Ghazi company 25% dextrose intraarticularly by needle (gauge 22) in 3 stages (one week apart) according to the usual protocol with the recommendation to follow the correct lifestyle and perform appropriate knee exercises Pain due to knee osteoarthritis. Timepoint: Before starting the intervention; 2, 4, 8, &12 weeks later. Method of measurement: Visual analog scale; Western Ontario and McMaster Universities Arthritis Index; Oxford knee scale; Patient satisfaction. Patient function. Timepoint: Before starting the intervention; 2, 4, 8, &12 weeks later. Method of measurement: Visual analog scale. Patient function. Timepoint: Before starting the intervention; 2, 4, 8, &12 weeks later. Method of measurement: Western Ontario and McMaster Universities Arthritis Index. Patient function. Timepoint: Before starting the intervention; 2, 4, 8, &12 weeks later. Method of measurement: Oxford knee scale. Shiraz University of Medical Sciences Approved 2020-08-17 Ethics committee of Shiraz University of Medical Sciences No. 82, Sepideh Tower, Baneshi Street, Parastar Blvd., Ehsan Square Shiraz Fars Iran (Islamic Republic of)