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IRCT20250622066221N1 IRCT 2025-08-18 Shiraz University of Medical Sciences A comparative study of the efficacy of piroxicam ampoule mesotherapy injection and shockwave modality on the clinical manifestations of knee osteoarthritis patients A comparative study of the efficacy of piroxicam ampoule mesotherapy injection and shockwave modality on the clinical manifestations of knee osteoarthritis patients 2025-09-02 anticipated 60 Complete https://irct.ir/trial/84355 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation method in this study will be the permuted block randomization with blocks of size four. In this method, "A" represents the individual receiving the intervention, and "B" represents the individual receiving the control. Considering blocks of four, the total number of possible permutations is six, which are: ABAB, BABA, AABB, BBAA, ABBA, and BAAB. Then, using a table of random numbers and assigning codes from 0 to 9 to each permutation, a random list of 60 assignments is generated. This list includes 25 blocks of four (4 × 25 = 60, which corresponds to the total sample size). The order of assigning each method to the study participants is then determined accordingly. For example, the permutations are assigned codes as follows: ABAB = 0, BABA = 1, AABB = 2, BBAA = 3, BAAB = 4, and ABBA = 5 to 9. Then, using a table of random numbers, a random starting point is selected, and 25 numbers are randomly chosen (either row-wise or column-wise). The permutation corresponding to each selected number is recorded. (The order of the permutations will be arranged from left to right.) This process determines the allocation of all 60 participants into the two groups, A and B, Blinding description: The study is one sided blind Clinical caregiver: to the person who is in charge of the care and follow-up of patients how to complete the questionnaires ,this person has no knowledge of the type of patients intervention . 3 Osteoarthritis of knee. The first intervention group: Patients received subcutaneous injections containing a combination of 20 mg, 1 ml of piroxicam and 5 cc of lidocaine 2%, in acupuncture points ST34, ST35, SP9, BL 38, SP10, LR7 around the knee ,The angle of the needle when entering the skin should be 30-45 degrees, after 10 days, the injection will be done again (each Patient will receive two mesotherapy sessions).The second intervention group: Under treatment with shock wave modality, patients will receive 0.05 millijoules per square millimeter of total energy with 1000 pulses per week for 3 weeks.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Ramin Ardeshiri
Emam hosaein dormitory ,hadaiat street
Shiraz Iran (Islamic Republic of) 7134934748 +98 83 3835 3624 ramin.ardeshiri@gmail.com Shiraz University of Medical Sciences scientific Sharareh roshanzamir
Emam hosaein dormitory , hedaiat street
Shiraz Iran (Islamic Republic of) 7134934748 +98 83 3835 3624 Sharareh.roshanzamir@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Mild to moderate knee osteoarthritis 35 years 75 years Both Injections in or around the knee joint in the last three months . Use of NSIAD in the last three days .History of cancer ,diabetes ,rheumatological disease and vascular collagen .Heat and redness in the knee ,History of knee injury ,History of knee Arthroplasty or other surgeries on the knee ,Presence of active Radiculopathy ,myopathy ,peripheral neuropathy ,Pregnancy or breastfeeding ,BMI>42 ,Allergy to piroxicam and other NSAID ,Severe gastrointestinal ,cardiovascular ,liver and kidney disease ,Any serious systemic or local infection such as brucellosis , Patients who have other musculoskeletal complications which Causes lower limb pain like secondary arthritis ,Patients who do Not complete the informed consent form to participate in the Study . M17 Osteoarthritis of knee Treatment - Drugs The first intervention group: Patients received subcutaneous injections containing a combination of 20 mg, 1 ml of piroxicam and 5 cc of lidocaine 2%, in acupuncture points ST34, ST35, SP9, BL 38, SP10, LR7 around the knee ,The angle of the needle when entering the skin should be 30-45 degrees, after 10 days, the injection will be done again (each Patient will receive two mesotherapy sessions).The second intervention group: Under treatment with shock wave modality, patients will receive 0.05 millijoules per square millimeter of total energy with 1000 pulses per week for 3 weeks. Osteoarthritis of knee. Timepoint: Measurement of knee joint cartilage thickness and evaluation of knee effusion before immediately after and one month after injection of piroxicam ampoule and shockwave modality. Method of measurement: Visual analog scale , western Ontario and Mc master universities arthritis index , Oxford knee scale. Improve pain and function. Timepoint: Investigation of pain improvement and performance ten days and one month after piroxicam mesotherapy injection and shockwave modality. Method of measurement: Visual analog scale , Western Ontario and Mc Master universities arthritis index ,oxford knee scale. Shiraz University of Medical Sciences Approved 2025-08-17 Ethics committee of Shiraz University of Medical Sciences Emam hosaein dormitory hedaiat street Shiraz Fars Iran (Islamic Republic of)