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IRCT20181217042028N2 IRCT 2019-04-18 Artesh University of Medical Sciences The Comparsion between Therapeutic Effects of Intra-articular Botulinum Neurotoxin , Hyaluronic Acid, Prolotherapy with Dextrose and Physical Therapy in Knee Osteoarthritis Comparsion between Therapeutic Effects of Intra-articular Botulinum Neurotoxin , Hyaluronic Acid, Prolotherapy with Dextrose and Physical Therapy in Knee Osteoarthritis 2018-06-22 anticipated 120 Complete https://irct.ir/trial/37274 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with Knee Osteoarthritis will be recruited from the waiting list of an outpatient Department of Physical Medicine and Rehabilitation at Imam Reza Hospital. The Hospital is a large referral subspecialty center in Tehran affiliated with Artesh University of Medical Sciences. We are going to use block randomization with variable block size to provide four samples of equal size. Random numbers will be generated with a computer in an independent statistical office, Blinding description: The participant will be informed of his treatment, benefits and disadvantages,then consciously and satisfied be entered the study. The researcher also knows the type of treatment.The person who evaluates the outcome and the analyzer do not have any information on the type of treatment and are kept Blind. 3 Osteoarthritis. Intervention 1: First Intervention group: Intra-articular injection of Botulinum Toxin at the knee. Intervention 2: Second Intervention group: Intra-articular injection of Hyaluronic Acid at the knee. Intervention 3: Third Intervention group: Intra-articular Prolotherapy with Dextrose at the knee. Intervention 4: Control group: Physical Therapy for Knee Osteoarthritis. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The Artesh Medical University must first obtain a license.
public Fatemeh Abdorrazaghi
Emam reza hospital, Etemadzade St, West Fatemi St
Tehran Iran (Islamic Republic of) 1411718541 +98 21 6652 1827 z.rezasoltani@ajaums.ac.ir Artesh University of Medical Sciences scientific Fatemeh Abdorrazaghi
Emam Reza hospital, Etemad zade Ave, West Fatemi Ave
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 z.rezasoltani@ajaums.ac.ir Artesh University of Medical Sciences Iran (Islamic Republic of) Age older than 50 Crepitus or morning stiffness for less than 30 minutes Radiographic finding Symptoms longer than 3 monthes 50 years no limit Both Patient dissatisfaction The presence of other knee joint diseases History of surgery in the desired joint History of fracture in knee bones Intra-articular corticosteroid injection in the last 2 weeks Contraindication of intera-articular injection Immunodeficeincy Sensitivity to botulinum toxin Dysfunction of the lower extremity due to neurological or internal medicine M17.1 Unilateral primary osteoarthritis of knee Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Devices First Intervention group: Intra-articular injection of Botulinum Toxin at the knee Second Intervention group: Intra-articular injection of Hyaluronic Acid at the knee Third Intervention group: Intra-articular Prolotherapy with Dextrose at the knee Control group: Physical Therapy for Knee Osteoarthritis Pain Severity based on Visual Analogue Scale. Timepoint: Before intervention, one and three months later. Method of measurement: Visual Analogue Scale. Artesh University of Medical Sciences Approved 2018-06-03 Ethics committee of Artesh University of Medical sciences Artesh medical university, Etemad zade Ave, West Fatemi Ave Tehran Tehran Iran (Islamic Republic of)