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IRCT20220903055865N1 IRCT 2022-10-02 Shiraz University of Medical Sciences Comparing the effectiveness of shock wave therapy and mesotherapy The Comparison of the effectiveness of Piroxicam mesotherapy versus Using Extracorporeal Shock Wave Therapy (ESWT) in Reducing Pain and Improving Function in Patients with rotator caff tendinopathy 2022-10-07 anticipated 60 Complete https://irct.ir/trial/65793 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to match the patients of the intervention and control groups, the patients are randomly divided. To perform randomization in this research, permutation block method with 4 samples in each block is used and the randomization list is obtained using Random Allocation software. We will have two lists of 30 people including intervention and control groups randomly. In order to hide the random sequence method, another person who is unaware of the research process is presented and the questionnaires are completed by a person who is unaware of the division of groups, Blinding description: Participant: In this study, we do not have the ability to blind the patient, because the patients of both interventions know the type of intervention. Clinical caregiver: We teach the person who is in charge of the care and follow-up of the patients how to complete the questionnaire. This person has no knowledge of the type of patient intervention. Researcher: In this study, we do not have the ability to blind the researcher, because the researcher conducts both studies himself and knows the type of intervention received in each group. Outcome evaluator: 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 increase in each person according to the questionnaire. Data analyst: 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 Shoulder Rotator cuff tendinopathy(Non-specific shoulder pain). Intervention 1: Intervention group: group A : Treatment of group A is to perform shock therapy session (ESWT) with frequency 10 and impulse 1000, intensity 2 to 3 based on patient tolerance, once a week for 6 weeks at the site of shoulder injury and correct lifestyle and exercise appropriate shoulder pain .Before entering the study and 2, 4, 8, and 12 weeks after the intervention, the patients completed the visual analog scale questionnaires and the Oxford shoulder score. Intervention 2: Control group: group B : subcutaneous injection of 1 ml of piroxicam 20 mg along with 4 ml of lidocaine 2% in the painful points and around the involved shoulder at a distance of at least 1 cm. Mesotherapy is performed in 3 stages with a one-week interval according to a common and sterile protocol along with the recommendation to follow the correct lifestyle and perform appropriate exercises for shoulder pain. Before entering the study and 2, 4, 8, and 12 weeks after the intervention, the patients completed the visual analog scale questionnaires and the Oxford shoulder score. Yes - There is a plan to make this available What will be shared: All available data can be shared after de-identifying people When: Access starts one year after results are published To whom: Everyone will have access to this information. Conditions: If the information of this study helps in improving the process of science Where to obtain: Fateme nazri/ 00989164900466 W.faezenazari98@yahoo.com How to obtain: After sending the desired message, we will talk with all the authors of this study and if necessary, all the information will be sent within a maximum of three weeks. Comments:
public Fateme nazari
Unit 1, No. 50, Peyman Building, Second Branch, 31 Alley, Farhang Shahr, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7185964655 36333973 W.faezenazari98@yahoo.com Shiraz University of Medical Sciences scientific Fateme nazari
Unit 1, No. 50, Peyman Building, Second Branch, 31 Alley, Farhang Shahr, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7185964655 36333973 W.faezenazari98@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Completing and signing the consent form Patients with shoulder pain lasting more than 4 weeks Shoulder pain with an Oxford shoulder score of at least 4 in the last month Age over 18 Absence of any type of disease around the relevant joint 18 years no limit Both Any pathology found on the plain radiograph, including degenerative findings of the shoulder joint Any clinical symptoms of effusion, inflammation, redness and warmth of the shoulder Having diabetes, uncontrolled blood pressure and rheumatic and vascular collagen diseases such as lupus, gout and simultaneous radiculopathy, myopathy, nerve damage and neuropathies such as carpal tunnel syndrome, stroke and any type of systemic infection. Body mass index above 42 History of joint replacement and trauma and fracture on the side of the involved shoulder Suffering from bleeding diseases and taking anticoagulant drugs Psychological problems Any hypersensitivity to drugs used in the study, such as piroxicam History of significant heart, kidney, liver, brain, lung disorders History of injections in or around the affected shoulder joint in the last 3 months History of shoulder and upper limb physiotherapy in the last one month Pregnant and lactating woman Cancer M25.519 Pain in unspecified shoulder Rehabilitation Rehabilitation Intervention group: group A : Treatment of group A is to perform shock therapy session (ESWT) with frequency 10 and impulse 1000, intensity 2 to 3 based on patient tolerance, once a week for 6 weeks at the site of shoulder injury and correct lifestyle and exercise appropriate shoulder pain .Before entering the study and 2, 4, 8, and 12 weeks after the intervention, the patients completed the visual analog scale questionnaires and the Oxford shoulder score. Control group: group B : subcutaneous injection of 1 ml of piroxicam 20 mg along with 4 ml of lidocaine 2% in the painful points and around the involved shoulder at a distance of at least 1 cm. Mesotherapy is performed in 3 stages with a one-week interval according to a common and sterile protocol along with the recommendation to follow the correct lifestyle and perform appropriate exercises for shoulder pain. Before entering the study and 2, 4, 8, and 12 weeks after the intervention, the patients completed the visual analog scale questionnaires and the Oxford shoulder score. Shoulder pain. Timepoint: Before intervention; Two weeks, four weeks, eight weeks and twelve weeks later. Method of measurement: Visual analogue scale, Oxford shoulder score. Patient performance. Timepoint: Before intervention; Two weeks, four weeks, eight weeks and twelve weeks later. Method of measurement: Oxford shoulder scale. Shiraz university of medical sciences Approved 2022-08-21 Ethics Committee of Shiraz University of Medical Sciences Unit 1, No. 50, Peyman Building, Shahid Rajaee Boulevard, Farhang Shahr, Shiraz, Iran Shiraz Fars Azerbaijan