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IRCT20230515058198N1 IRCT 2023-07-24 Shiraz University of Medical Sciences Investigating the effect of piroxicam mesotherapy in the treatment of tennis elbow LET Investigation of the effect of mesotherapy with piroxicam in the treatment of tennis elbow in comparison with oral medical therapy in terms of improving pain and function 2023-08-01 anticipated 36 Complete https://irct.ir/trial/71349 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated into two groups by Block Randomization Assignment and double blind methods. We will have two lists of 18 patients including the intervention and control groups, at random. For concealment, method of random sequencing is given to another individual who is unaware of the research process. All questionnaires will be completed by an individual unaware of the division of groups, Blinding description: Participant: in this study, we do not have the ability to blind the participant because the participants are aware of receiving each intervention. Clinical care giver: we instruct the caregiver how to complete the questionnaires. 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 completed questionnaires is given to an individual who is not aware of the interventions and he/she is asked to determine the level of performance in each subject 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 study and the way of classification in which the interventions performed. N/A Lateral epicondylitis. Intervention 1: Intervention group: Subcutaneous injection (mesotherapy) of 1 ml piroxicam 20 mg/ml with 1 ml lidocaine 2% is applied in the acupuncture points Lu6, Li10, Li11, Li12 and the maximal tender point of the affected elbow. Mesotherapy is performed in 2 sessions at intervals of one week according to the common and sterile protocol along with lifestyle modification, doing stretching and strengthening exercises of the wrist extensor muscles and using tennis elbow band. The patients have to complete the Visual Analog Scale and Patient-Rated Tennis Elbow Evaluation questionnaires before entering the study and 2 and 4 weeks after intervention. Intervention 2: Control group: Oral naproxen 500 mg twice a day (one every 12 hours) is used for seven days. Oral medical treatment is done along with lifestyle modification, doing stretching and strengthening exercises of the wrist extensor muscles and using tennis elbow band. The patients have to complete the Visual Analog Scale and Patient-Rated Tennis Elbow Evaluation questionnaires before entering the study and 2 and 4 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. Zahra Zare, 00989173296042, niloofarzare@sums.ac.ir 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 Zahra Zare
7th floor, unit 52, Imam Hossein dormitory medical science building, 36th alley, Zand Blvd.
Shiraz Iran (Islamic Republic of) 7135744661 +98 71 3231 5768 niloofarzare@sums.ac.ir Shiraz University of Medical Sciences scientific Zahra Zare
7th floor, unit 52, Imam Hossein dormitory medical science building, 36th alley, Zand Blvd.
Shiraz Iran (Islamic Republic of) 7135744661 +98 71 3231 5768 niloofarzare@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Completing and signing the consent form Clinical diagnosis of tennis elbow in the form of pain in the external epicondyle region of the humerus bone by applying local pressure and wrist extension against resistance At least one month has passed since the onset of the patient's symptoms Having a pain Visual Analogue Scale of at least 4 20 years 60 years Both Any signs and symptoms of effusion, inflammation, redness and warmth of the affected area Having uncontrolled diabetes mellitus Having rheumatic and collagen vascular disorders Suffering from active cervical radiculopathy, neuropathy or myopathy simultaneously in the upper limbs Having any type of serious systemic and local infection History of surgery, trauma, fracture and dislocation in the elbow joint on the affected side, severe deformity in the upper limb Individuals with bleeding disorders and/or taking anticoagulants History of allergies and allergic reactions to the medications used History of significant liver, kidney, gastrointestinal, cerebral and cardiopulmonary disorders, history of gastrointestinal bleeding History of injections in or around the affected elbow joint in the last three months History of elbow and upper limb physiotherapy in the last one month Taking non-steroidal anti-inflammatory drugs (NSAIDs) in the last 48 hours and steroidal anti-inflammatory drugs in the last two weeks Pregnant women and lactating women Individuals with cancer Inability to communicate and complete questionnaires M77.1 Lateral epicondylitis Rehabilitation Rehabilitation Intervention group: Subcutaneous injection (mesotherapy) of 1 ml piroxicam 20 mg/ml with 1 ml lidocaine 2% is applied in the acupuncture points Lu6, Li10, Li11, Li12 and the maximal tender point of the affected elbow. Mesotherapy is performed in 2 sessions at intervals of one week according to the common and sterile protocol along with lifestyle modification, doing stretching and strengthening exercises of the wrist extensor muscles and using tennis elbow band. The patients have to complete the Visual Analog Scale and Patient-Rated Tennis Elbow Evaluation questionnaires before entering the study and 2 and 4 weeks after intervention. Control group: Oral naproxen 500 mg twice a day (one every 12 hours) is used for seven days. Oral medical treatment is done along with lifestyle modification, doing stretching and strengthening exercises of the wrist extensor muscles and using tennis elbow band. The patients have to complete the Visual Analog Scale and Patient-Rated Tennis Elbow Evaluation questionnaires before entering the study and 2 and 4 weeks after intervention. Upper limb pain. Timepoint: Before intervention, two weeks and four weeks later. Method of measurement: Visual Analogue Scale (VAS); Patient-Rated Tennis Elbow Evaluation (PRTEE). Function of patient. Timepoint: Before intervention, two weeks and four weeks later. Method of measurement: Patient-Rated Tennis Elbow Evaluation (PRTEE). Shiraz University of Medical Sciences Approved 2023-05-06 Ethics committee of Shiraz University of Medical Sciences 7th floor, unit 52, Imam Hossein dormitory medical science building, 36th alley, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)