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IRCT20190921044831N2 IRCT 2021-10-29 Mashhad University of Medical Sciences Effectiveness evaluation of hypertonic dextrose therapy in knee osteoarthritis Effects of Prolotherapy with Hypertonic Dextrose in Patients with Osteoarthritis of the Knee: A Randomized Clinical Trial 2021-09-23 anticipated 80 Complete https://irct.ir/trial/54324 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization based on a random number table, Blinding description: Preparation and allocation of drugs (25% dextrose) and placebo (normal saline 0.9%) were performed by a nurse, therefore, patients in both control and intervention groups. The rheumatologist who was injecting and the data analyzer were blinded to the condition. 3 Knee Osteoarthrits. Intervention 1: Intervention group: 80 patients with mild to moderate osteoarthritis of the knee aged 75-45 years for whom the diagnosis was made by physical examination and knee AP graphy according to the criterion (grade lawrence-kellgren) by a rheumatologist based on the inclusion criteria. the patients who were referred to the clinic of Ghaem and Imam Reza hospitals and the specialists' office in Mashhad were selected and after filling out the consent form, they entered the study. they were followed up for 24 weeks. The sample selection was done through random numbers and the consort chart. For each patient, first, sufficient explanations are given about the plan and performance of it and also, the benefits of the injection and the possible side effects of it. The consent form and womac and (scale pain knee) Kps are completed and before starting the procedure, an oxycodone 30 mg tablet is prescribed by Farman Shimi Pharmaceutical Company.The syringes were prepared by a nurse who is not aware of the content of Syringes. syringes in the intervention group contained 5% dextrose and 25% dextrose from Samen Pharmaceutical Company (Mashhad-Iran). In supine position and in the knee with flexion of 10 to 15 degrees, intraarticularly by lateral approach method, under sterile conditions, injection of 6 cc of 25% dextrose solution with 2 cc of lidocaine Caspian vial injected with 22 g needle and 20 cc 5% dextrose solution with lidocaine is injected into the tissues and ligaments around it. The injection is given monthly for 3 months. Injectable dextrose in the knee is not a complication and, if present, includes local pain and a small accumulation of fluid in the tissue at the injection site, and rarely rash, urticaria, and itching at the injection site; It is a muscle cramp and paresthesia that all patients are given full explanations about the side effects of the drug so that in case of any of the side effects, they can immediately call the phone number given by the treating physician or, if possible, visit in person to relieve pain symptoms. And swelling of the injection site is given to NSAID patients and if necessary, the NSAID form is given and the patients' follow-up is done at intervals of 4, 8, 12, 16, 20 and 24 weeks after the injection and the KPS and WOMAC questionnaires are filled out. Patients are advised to take acetaminophen as needed for a week and have a relative rest for the first three days. Patients are also advised to avoid analgesic NSAIDs and dietary supplements if possible during treatment. In case of severe need, indicate the number of days and days of drug use in the form of medication delivered to the patient and refrain from physiotherapy during treatment and do not use NSAIDs 48 hours before referral and injection. Clinical status and function of the patient with a questionnaire womac, Kps are checked in person at each visit and in weeks 4, 8, 12, 16, 20 and 24 and patients are given a mobile number and a landline number. Intervention 2: Control group: 80 patients with mild to moderate osteoarthritis of the knee aged 75-45 years for whom the diagnosis was made by physical examination and knee AP graphy according to the criterion (grade lawrence-kellgren) by a rheumatologist based on the inclusion criteria. the patients who were referred to the clinic of Ghaem and Imam Reza hospitals and the specialists' office in Mashhad were selected and after filling out the consent form, they entered the study. they were followed up for 24 weeks. The sample selection was done through random numbers and the consort chart. For each patient, first, sufficient explanations are given about the plan and performance of it and also, the benefits of the injection and the possible side effects of it. The consent form and womac and (scale pain knee) Kps are completed and before starting the procedure, an oxycodone 30 mg tablet is prescribed by Farman Shimi Pharmaceutical Company.The syringes were prepared by a nurse who is not aware of the content of Syringes. The syringes in the control group contained Normal Saline 0.9% Samen Pharmaceutical Company (Mashhad-Iran). In supine position and in the knee with flexion of 10 to 15 degrees, intraarticularly by lateral approach method, under sterile conditions, injection of the present, includes local pain and a small accumulation of fluid in the tissue at the injection site, and rarely rash, urticaria, and itching at the injection site; It is a muscle cramp and paresthesia that all patients are given full explanations about the side effects of the drug so that in case of any of the side effects, they can immediately call the phone number given by the treating physician or, if possible, visit in person to relieve pain symptoms. And swelling of the injection site is given to NSAID patients and if necessary, the NSAID form is given and the patients' follow-up is done at intervals of 4, 8, 12, 16, 20 and 24 weeks after the injection and the KPS and WOMAC questionnaires are filled out. Patients are advised to take acetaminophen as needed for a week and have a relative rest for the first three days. Patients are also advised to avoid analgesic NSAIDs and dietary supplements if possible during treatment. In case of severe need, indicate the number of days and days of drug use in the form of medication delivered to the patient and refrain from physiotherapy during treatment and do not use NSAIDs 48 hours before referral and injection. Clinical status and function of the patient with a questionnaire womac, Kps are checked in person at each visit and in weeks 4, 8, 12, 16, 20 and 24 and patients are given a mobile number and a landline number. Yes - There is a plan to make this available What will be shared: How to sample, number of participants, how to group When: after publishing the Extracted article To whom: Researchers who have evidence of intent to use documentation in new research Conditions: Submitting the code of ethics and the code of approval of the proposal related to the new research requires the documents of this study Where to obtain: Scientific responsible for the trial How to obtain: Sending Email to the author of the article containing the official request and the code of ethics and the code of approval of their proposal, coordination with the ethics committee of Mashhad University, the consent of all project collaborators and finally making the information available to the researcher Comments:
public Maasoomeh Salari
Imam Reza Hospital Square, Ibn Sina St.
Mashhad Iran (Islamic Republic of) 9137913316 0538543031 Salarim@mums.ac.ir Mashhad University of Medical Sciences scientific Maasoomeh Salari
Imam Reza Hospital Square, Ibn Sina St.
Mashhad Iran (Islamic Republic of) 9137913316 0513802237071 Salarim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients with mild to moderate knee osteoarthritis aged 45-75 years according to Kellgren-Lawrence criteria and rheumatologist approval Absence of rheumatic diseases such as Rheumatoid Arthritis Pain and tenderness of the knee joint resistant to medicine and conservative therapy for 3 months 45 years 75 years Both Pregnancy Medicine allergy to Oxycodone and Lidocaine 40kg/m2<BMI History of previous prolotherapy Loosening of ligaments and knee joint History of diabetes History of hematologic disease, especially with palpitations History of taking anticoagulants such as Plavix and warfarin History of joint injection in the last 3 months History of inflammatory joint disease and history of knee joint infection People who are candidates for knee surgery with grade 4 based on Kellgren-lawrence History of joint replacement and presence of joint prosthesis M15.0 Primary generalized (osteo)arthritis Treatment - Drugs Treatment - Drugs Intervention group: 80 patients with mild to moderate osteoarthritis of the knee aged 75-45 years for whom the diagnosis was made by physical examination and knee AP graphy according to the criterion (grade lawrence-kellgren) by a rheumatologist based on the inclusion criteria. the patients who were referred to the clinic of Ghaem and Imam Reza hospitals and the specialists' office in Mashhad were selected and after filling out the consent form, they entered the study. they were followed up for 24 weeks. The sample selection was done through random numbers and the consort chart. For each patient, first, sufficient explanations are given about the plan and performance of it and also, the benefits of the injection and the possible side effects of it. The consent form and womac and (scale pain knee) Kps are completed and before starting the procedure, an oxycodone 30 mg tablet is prescribed by Farman Shimi Pharmaceutical Company.The syringes were prepared by a nurse who is not aware of the content of Syringes. syringes in the intervention group contained 5% dextrose and 25% dextrose from Samen Pharmaceutical Company (Mashhad-Iran). In supine position and in the knee with flexion of 10 to 15 degrees, intraarticularly by lateral approach method, under sterile conditions, injection of 6 cc of 25% dextrose solution with 2 cc of lidocaine Caspian vial injected with 22 g needle and 20 cc 5% dextrose solution with lidocaine is injected into the tissues and ligaments around it. The injection is given monthly for 3 months. Injectable dextrose in the knee is not a complication and, if present, includes local pain and a small accumulation of fluid in the tissue at the injection site, and rarely rash, urticaria, and itching at the injection site; It is a muscle cramp and paresthesia that all patients are given full explanations about the side effects of the drug so that in case of any of the side effects, they can immediately call the phone number given by the treating physician or, if possible, visit in person to relieve pain symptoms. And swelling of the injection site is given to NSAID patients and if necessary, the NSAID form is given and the patients' follow-up is done at intervals of 4, 8, 12, 16, 20 and 24 weeks after the injection and the KPS and WOMAC questionnaires are filled out. Patients are advised to take acetaminophen as needed for a week and have a relative rest for the first three days. Patients are also advised to avoid analgesic NSAIDs and dietary supplements if possible during treatment. In case of severe need, indicate the number of days and days of drug use in the form of medication delivered to the patient and refrain from physiotherapy during treatment and do not use NSAIDs 48 hours before referral and injection. Clinical status and function of the patient with a questionnaire womac, Kps are checked in person at each visit and in weeks 4, 8, 12, 16, 20 and 24 and patients are given a mobile number and a landline number. Control group: 80 patients with mild to moderate osteoarthritis of the knee aged 75-45 years for whom the diagnosis was made by physical examination and knee AP graphy according to the criterion (grade lawrence-kellgren) by a rheumatologist based on the inclusion criteria. the patients who were referred to the clinic of Ghaem and Imam Reza hospitals and the specialists' office in Mashhad were selected and after filling out the consent form, they entered the study. they were followed up for 24 weeks. The sample selection was done through random numbers and the consort chart. For each patient, first, sufficient explanations are given about the plan and performance of it and also, the benefits of the injection and the possible side effects of it. The consent form and womac and (scale pain knee) Kps are completed and before starting the procedure, an oxycodone 30 mg tablet is prescribed by Farman Shimi Pharmaceutical Company.The syringes were prepared by a nurse who is not aware of the content of Syringes. The syringes in the control group contained Normal Saline 0.9% Samen Pharmaceutical Company (Mashhad-Iran). In supine position and in the knee with flexion of 10 to 15 degrees, intraarticularly by lateral approach method, under sterile conditions, injection of the present, includes local pain and a small accumulation of fluid in the tissue at the injection site, and rarely rash, urticaria, and itching at the injection site; It is a muscle cramp and paresthesia that all patients are given full explanations about the side effects of the drug so that in case of any of the side effects, they can immediately call the phone number given by the treating physician or, if possible, visit in person to relieve pain symptoms. And swelling of the injection site is given to NSAID patients and if necessary, the NSAID form is given and the patients' follow-up is done at intervals of 4, 8, 12, 16, 20 and 24 weeks after the injection and the KPS and WOMAC questionnaires are filled out. Patients are advised to take acetaminophen as needed for a week and have a relative rest for the first three days. Patients are also advised to avoid analgesic NSAIDs and dietary supplements if possible during treatment. In case of severe need, indicate the number of days and days of drug use in the form of medication delivered to the patient and refrain from physiotherapy during treatment and do not use NSAIDs 48 hours before referral and injection. Clinical status and function of the patient with a questionnaire womac, Kps are checked in person at each visit and in weeks 4, 8, 12, 16, 20 and 24 and patients are given a mobile number and a landline number. Score of WOMAC questionnaire. Timepoint: 4, 8, 12, 16, 20, 24 weeks after injection. Method of measurement: Score of WOMAC questionnaire. Clinical and functional status of the joint and persistence of the drug for 6 months after ending the treatment. Timepoint: 6 months after ending the treatment. Method of measurement: Questionnaire and clinical assessment. Mashhad University of Medical Sciences Approved 2021-08-29 Medical Ethics Committee of Mashhad University of Medical Sciences Azadi Square, east door of the university campus Mashhad Razavi Khorasan Iran (Islamic Republic of)