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IRCT20100827004641N16 IRCT 2020-08-24 Iran university of medical sciences Sono-guided prolotherapy/ oxygen-ozone/ corticosteroid therapy for the treatment of musculoskeletal pain in physical and rehabilitation medicine: Interventional pain management for trochanteric bursitis: a prospective, randomized, double-blind, positive control, multicenter clinical trial. Sono-guided prolotherapy/ oxygen-ozone/ corticosteroid therapy for the treatment of musculoskeletal pain in physical and rehabilitation medicine: Interventional pain management for trochanteric bursitis: a prospective, randomized, double-blind, positive control, multicenter clinical trial. 2020-01-18 anticipated 48 Complete https://irct.ir/trial/49959 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A block randomization method will be used to allocate participants to the groups with a 1:1:1 allocation using random allocation software (RAS) with block sizes of 3 and 6. Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package, Blinding description: Away from the patient's eye, prepare the injection material in the syringe and cover the syringes with an aluminum foil so that the person does not know the type of injection material. Patients in each group will be evaluated by a physical medicine and rehabilitation assistant who is not aware of the type of injection before the injection, one week later, and two months after the injection. It should be noted that in each center, all injections are performed by a fixed person (specialist in physical medicine and rehabilitation). N/A Trochanteric bursitis. Intervention 1: Intervention group A :after providing sterile conditions with Povidone-Iodine solution, anesthesia is performed locally with 1 cc of 2% lidocaine and 22 gage needle. For all patients, the injection will be performed under ultrasound guidance and using needle number 27 after aspiration and ensuring the correct placement of the needle. Any other medication should be avoided during treatment and follow-up will be one week after injection and two months after injection. Intervention 2: Intervention group B: after providing sterile conditions with Povidone-Iodine solution, anesthesia is performed locally with 1 cc of 2% lidocaine and 22 gage needle. For all patients, the injection will be performed under ultrasound guidance and using needle number 27 after aspiration and ensuring the correct placement of the needle. Any other medication should be avoided during treatment and follow-up will be one week after injection and two months after injection. Intervention 3: Intervention group C: after providing sterile conditions with Povidone-Iodine solution, anesthesia is performed locally with 1 cc of 2% lidocaine and 22 gage needle. For all patients, the injection will be performed under ultrasound guidance and using needle number 27 after aspiration and ensuring the correct placement of the needle. Any other medication should be avoided during treatment and follow-up will be one week after injection and two months after injection. Yes - There is a plan to make this available What will be shared: paper When: 2020 To whom: students Conditions: research Where to obtain: Tabriz university of medical sciences How to obtain: email Comments:
public Bina Eftekharsadat
Rehabilitation ward, Imam Reza hospital, Golgasht ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1330 3193 binasadat@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Bina Eftekharsadat
Rehabilitation ward, Imam Reza hospital, Golgasht ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1330 3193 binasadat@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Pain in the back of the trochanter that also has local tenderness 46 years 46 years Both The presence of pathology in the hip joint Rheumatic disease Calcification at the injection site Any skin infection at the injection site History of injection or on-site physiotherapy in the last 2 month Coagulation disorders Existence of lumbosacral radiculopathy M70.6 Trochanteric bursitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group A :after providing sterile conditions with Povidone-Iodine solution, anesthesia is performed locally with 1 cc of 2% lidocaine and 22 gage needle. For all patients, the injection will be performed under ultrasound guidance and using needle number 27 after aspiration and ensuring the correct placement of the needle. Any other medication should be avoided during treatment and follow-up will be one week after injection and two months after injection. Intervention group B: after providing sterile conditions with Povidone-Iodine solution, anesthesia is performed locally with 1 cc of 2% lidocaine and 22 gage needle. For all patients, the injection will be performed under ultrasound guidance and using needle number 27 after aspiration and ensuring the correct placement of the needle. Any other medication should be avoided during treatment and follow-up will be one week after injection and two months after injection. Intervention group C: after providing sterile conditions with Povidone-Iodine solution, anesthesia is performed locally with 1 cc of 2% lidocaine and 22 gage needle. For all patients, the injection will be performed under ultrasound guidance and using needle number 27 after aspiration and ensuring the correct placement of the needle. Any other medication should be avoided during treatment and follow-up will be one week after injection and two months after injection. Pain intensity. Timepoint: Evaluating the visual analogue scale at the beginning of the study (before intervention) and 7 and 60 days after injection. Method of measurement: Visual analogue Scale. Overall recovery rate. Timepoint: Evaluating the overall recovery rate at 7 and 60 days after injection. Method of measurement: Patient Global Impression of Improvement. Iran university of medical sciences Approved 2020-01-18 Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)