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IRCT20210423051050N1 IRCT 2021-05-11 Shiraz University of Medical Sciences Evaluation of the Effect of Subcutaneous Injection of Piroxicam in Patients with Non Specific Shoulder Pain The Comparison of the Effectiveness of Piroxicam Mesotherapy versus Ultrasound-Guided Corticosteroid Injection in Reducing Pain and Improving Function in Patients with Non Specific Shoulder Pain 2021-06-21 anticipated 58 Complete https://irct.ir/trial/55888 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To match patients in the intervention and control groups, patients are randomly assigned to one of two treatment groups. The random allocation method in this study will be the permutation blocks randomization method with 4 samples in each block and a random list of data will be obtained by using Random Allocation software. We will have two lists of 29 patients, including the two intervention and control groups, at random. For concealment, method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by a person unaware of the division of groups, Blinding description: Participant: in this study, we does not have the ability to blind the participant because the participant is aware of receiving each intervention. Clinical care giver: we teach the caregiver how to complete the questionnaire. This person is not aware of receiving patient’s intervention. Researcher: this study does not have the ability to blind the researcher due to performing both interventions by himself and being aware of receiving the kind of intervention in each group. The outcome assessor of the complete questionnaires is given to a person who is not aware of the intervention performed and he/she is asked to determine the level of performance in each person according to the questionnaires. Data analyzer: questionnaire are finally given to a person to review the information. This person does not know any of the steps of the work and the way of classification in which the intervention performed. N/A Non Specific Shoulder Pain. Intervention 1: Intervention group: Subcutaneous injection (mesotherapy) of 1 ml piroxicam 20 mg/ml with 4 ml lidocaine 2% is applied in tender points of the affected shoulder and around the affected shoulder as a grid pattern where each point was at least 1 cm away from the others. Mesotherapy is performed in 3 sessions at intervals of one week according to the common and sterile protocol along with lifestyle modification and doing appropriate exercises for shoulder pain. The patients have to complete the Visual Analog Scale and Oxford Shoulder Score questionnaires before entering the study and 2,4,8 and 12 weeks after intervention. Intervention 2: Control group: Injection of 1 ml corticosteroid methylprednisolone acetate 40 mg/ml with 4 ml lidocaine 2% is applied locally at the site of the lesion and in the affected shoulder under guide of ultrasonography. Corticosteroid injection is performed in one session according to the common and sterile protocol along with lifestyle modification and doing appropriate exercises for shoulder pain. The patients have to complete the Visual Analog Scale and Oxford Shoulder Score questionnaires before entering the study and 2,4,8 and12 weeks after intervention. Yes - There is a plan to make this available What will be shared: All available 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. Mohammad Hossein Jabbedari, 00989389443577 , ja.mohammadh@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 Mohammad Hossein Jabbedari
6th Alley, Takestan Ave., Shahid Rajaei Blvd.
Shiraz Iran (Islamic Republic of) 7185988717 +98 71 3633 2701 ja.mohammadh@gmail.com Shiraz University of Medical Sciences scientific Mohammad Hossein Jabbedari
6th Alley, Takestan Ave., Shahid Rajaei Blvd.
Shiraz Iran (Islamic Republic of) 7185988717 +98 71 3633 2701 ja.mohammadh@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients over 18 years of age Male or Female gender Completing and signing the informed consent form Patients with shoulder pain lasted more than 4 weeks and with a shoulder pain Visual Analog Scale (VAS) score of at least 4 in a recent month Absence of any disease around the affected shoulder joint 18 years no limit Both Any pathology found on plain radiograph such as degenerative findings of the shoulder joint Any clinical signs of effusion, inflammation, redness and warmth of the affected shoulder Diabetes Mellitus Uncontrolled Hypertension Rheumatic and Collagen Vascular Diseases such as Lupus and Gout Concomitant Radiculopathy (cervical radiculopathy), Myopathy, Nerve injuries and Neuropathies (including CTS) Stroke Any serious systemic and local infection Brucellosis BMI above 42 History of shoulder joint replacement on the affected side History of shoulder trauma and fracture and severe deformities of the upper limbs Bleeding tendency and bleeding disorders and/or use of anticoagulants Inability to communicate and complete questionnaires (Mental and Psychological problems) History of allergies and allergic reactions to the used drugs including piroxicam, corticosteroids and lidocaine History of significant liver, kidney, brain and cardiopulmonary disorders History of intraarticular or periarticular injections at the affected shoulder joint in the last 3 months History of shoulder and upper limb physiotherapy (physical therapy) in the last 1 month Pregnant and Lactating women Patients with Cancer or Malignancy M25.519 Pain in unspecified shoulder Rehabilitation Rehabilitation Intervention group: Subcutaneous injection (mesotherapy) of 1 ml piroxicam 20 mg/ml with 4 ml lidocaine 2% is applied in tender points of the affected shoulder and around the affected shoulder as a grid pattern where each point was at least 1 cm away from the others. Mesotherapy is performed in 3 sessions at intervals of one week according to the common and sterile protocol along with lifestyle modification and doing appropriate exercises for shoulder pain. The patients have to complete the Visual Analog Scale and Oxford Shoulder Score questionnaires before entering the study and 2,4,8 and 12 weeks after intervention. Control group: Injection of 1 ml corticosteroid methylprednisolone acetate 40 mg/ml with 4 ml lidocaine 2% is applied locally at the site of the lesion and in the affected shoulder under guide of ultrasonography. Corticosteroid injection is performed in one session according to the common and sterile protocol along with lifestyle modification and doing appropriate exercises for shoulder pain. The patients have to complete the Visual Analog Scale and Oxford Shoulder Score questionnaires before entering the study and 2,4,8 and12 weeks after intervention. Shoulder pain. Timepoint: Before intervention; two weeks, four weeks, eight weeks and twelve weeks later. Method of measurement: Visual Analogue Scale; Oxford Shoulder Score. Function of patient. Timepoint: Before intervention; two weeks, four weeks, eight weeks and twelve weeks later. Method of measurement: Oxford Shoulder Score. Shiraz University of Medical Sciences Approved 2021-04-21 Ethics committee of Shiraz University of Medical Sciences 6th Alley, Takestan Ave., Shahid Rajaei Blvd. Shiraz Fars Iran (Islamic Republic of)