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IRCT20220718055488N1 IRCT 2022-07-28 Shiraz University of Medical Sciences Effect of Methyl Prednisolone Acetate injection at the Jianqian Acupoint in Patients with Non Specific Shoulder Pain Comparison of the Effectiveness of Methyl Prednisolone Acetate Injection at the Jianqian Acupoint versus Oral Piroxicam in Reducing Pain and Improving Function in patients with Non Specific Shoulder Pain 2022-08-06 anticipated 58 Complete https://irct.ir/trial/64847 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation method in this study will be permutation block method in such a way that A represents the person for whom injection is done and B represents the person who receives oral Piroxicam. This method is based on blocks of six so that the total number of possible permutations of six is ​​equal to 6 (including: ABAB, BABA, AABB, BBAA, ABBA and BAAB). Then, by using the table of random numbers and assigning a code from 0 to 9 to each of the permutations, the desired random list of 60 items, which includes 15 blocks of 4 items (total number of samples = 60 x 15) is generated and the order of assigning each One of the methods is specified for each of the samples participating in the study, Blinding description: Participant: In this study, we do not have the ability to blind the patient because the patients are aware of the type of intervention. Clinical caregiver: We train the person who is in charge of the care and follow-up of patients how to complete the questionnaire. This person has no awareness of the patient's intervention. Researcher: In this study, we do not have the ability to blind the researcher because the intervention is carried out by him. Outcome assessor: Completed questionnaires are given to a person who does not know about the interventions and he is asked to determine the amount of pain reduction and performance improvement in each person according to the questionnaire. Data Analyzer:Finally, after completing and collecting all the information, the questionnaires are given to a person to check the information, who does not know about any of the work steps and how the intervention is divided. N/A Non Specific Shoulder Pain. Intervention 1: Intervention group: At the Jianqian acupoint, which is between the axillary fold and the LI-15 acupoint (under the acromion), we inject a mixture of 40 mg of Methyl Prednisolone Acetate and 4 ml of Lidocaine2% in 5 directions in such a way that First, we insert the needle perpendicularly about 1.5 to 2 cm on the joint surface and outside the capsule and inject 1 cc of the substance, then without removing the needle, by changing the direction angle to 40 degrees to the vertical line , at upward ,downward and outside , we inject one cc on each side. At the inside, we enter at an angle of 10 degrees to the perpendicular line close to the joint capsule, and we are careful not to enter the pleura, and the injection is done. During the injection, we pay attention to the patient's reactions so as not to enter the blood vessels and nerves. Intervention 2: Control group: They take 10 mg Piroxicam capsules twice daily after meal and with enough water. Yes - There is a plan to make this available What will be shared: All 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.lale zare dr.lalezare@gmail.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 three weeks if permitted. Comments:
public Lale Zare
No.3, 2nd Alley, Rayehe Ave, Golestan Town
Shiraz Iran (Islamic Republic of) 7189895361 +98 71 3621 2959 dr.lalezare@gmail.com Shiraz University of Medical Sciences scientific Lale Zare
No. 3, 2nd Alley, Rayehe Ave, Golestan Town
Shiraz Iran (Islamic Republic of) 7189895361 +98 71 3621 2959 dr.lalezare@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients over 18 years old Non-specific shoulder pain lasted more than 6 weeks Limitation of active range of motion in at least one plane Absence of any disease around the affected shoulder Completing and signing the informed consent 18 years no limit Both Any systemic or local infection Acute trauma Fracture or Dislocation Malignancy Liver or Renal failure Gastrointestinal disease, Cardiovascular disease, Asthma, DM, uncontrolled HTN History of injection or physical therapy during the last month Clinical symptoms of inflammation or infection Severe deformity of shoulder Any bleeding tendency disorders or use of anti coagulants Active rheumatologic disease Post stroke shoulder pain History of allergic reactions to the used drugs Pregnant or Lactating women Inability to communicate and completing questionnaires M25.519 Pain in unspecified shoulder Rehabilitation Rehabilitation Intervention group: At the Jianqian acupoint, which is between the axillary fold and the LI-15 acupoint (under the acromion), we inject a mixture of 40 mg of Methyl Prednisolone Acetate and 4 ml of Lidocaine2% in 5 directions in such a way that First, we insert the needle perpendicularly about 1.5 to 2 cm on the joint surface and outside the capsule and inject 1 cc of the substance, then without removing the needle, by changing the direction angle to 40 degrees to the vertical line , at upward ,downward and outside , we inject one cc on each side. At the inside, we enter at an angle of 10 degrees to the perpendicular line close to the joint capsule, and we are careful not to enter the pleura, and the injection is done. During the injection, we pay attention to the patient's reactions so as not to enter the blood vessels and nerves. Control group: They take 10 mg Piroxicam capsules twice daily after meal and with enough water. Shoulder pain. Timepoint: Before intervention and two, four and eight weeks after intervention. Method of measurement: Visual Analog Scale and Oxford Shoulder Score questionnaires. Range of motion of shoulder. Timepoint: Before intervention and two, four and eight weeks after intervention. Method of measurement: By goniometer, which is a device for measuring angles, the one that is used in this study is a plastic type with 360 degree rotation and an arm length of 30 cm. Function of patient. Timepoint: Before intervention and two, four and eight weeks after intervention. Method of measurement: Shoulder Pain And Disability Index and Oxford Shoulder Scale questionnaires. Shiraz University of Medical Sciences Approved 2022-05-23 Ethics committee ofShiraz University of Medical Sciences Shiraz university of medical science, Zand Ave Shiraz Fars Iran (Islamic Republic of)