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IRCT20250122064481N1 IRCT 2025-01-24 Shiraz University of Medical Sciences Investigating the effect of acupuncture versus mesotherapy in the treatment of tennis elbow compared to the control group (oral medication and splinting alone) Investigating the effect of acupuncture versus mesotherapy in the treatment of tennis elbow compared to the control group (oral medication and splinting alone) 2025-02-19 anticipated 54 Complete https://irct.ir/trial/81469 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The differences of opinion among the treatment methods for tennis elbow and the lack of a study comparing the effect of mesotherapy and acupuncture against the control group in the treatment of these patients, due to the safety and low cost of these two treatment methods and the absence of side effects Other treatment methods such as side effects caused by corticosteroid injection, this study was conducted with the aim of comparing these treatment methods, Randomization description: Randomization: The random allocation method in this study will be the permutation block method of 6 such that A represents the person who receives intervention 1, B represents the person who receives intervention 2, and C represents the person who is placed in the control group. How to hide the allocation of participants: 1. A______________________________________ 2. C______________________________________ 3. C______________________________________ 4. C______________________________________ 5. A______________________________________ 6. B______________________________________ 7. B______________________________________ 8. B______________________________________ 9. C______________________________________ 10. A______________________________________ 11. B______________________________________ 12. C______________________________________ 13. C______________________________________ 14. B______________________________________ 15. A______________________________________ 16. A______________________________________ 17. A______________________________________ 18. B______________________________________ 19. B______________________________________ 20. B______________________________________ 21. C______________________________________ 22. A______________________________________ 23. B______________________________________ 24. A______________________________________ 25. B______________________________________ 26. C______________________________________ 27. A______________________________________ 28. C______________________________________ 29. A______________________________________ 30. A______________________________________ 31. B______________________________________ 32. C______________________________________ 33. A______________________________________ 36. C______________________________________ 35. C______________________________________ 36. B______________________________________ 37. B______________________________________ 38. B______________________________________ 39. C______________________________________ 40. A______________________________________ 41. C______________________________________ 42. B______________________________________ 43. B______________________________________ 44. A______________________________________ 45. C______________________________________ 46. A______________________________________ 47. A______________________________________ 48. C______________________________________ 49. B______________________________________ 50. A______________________________________ 51. A______________________________________ 52. C______________________________________ 53. B______________________________________ 54. C______________________________________ In order to hide the random sequence method, another person who is unaware of the research process is provided, and the questionnaires are completed by a person who is unaware of the division of the groups. 3 Tennis elbow. Intervention 1: The first intervention group: to perform mesotherapy with piroxicam, we insert the needle into the skin at an angle of 10 degrees and horizontally. The needle entry point is the acupuncture points Lu5, Li10, Li11, Li12 and the maximum tenderness point, which is composed of one cc of piroxicam 20 mg. And 4 cc of 2% lidocaine is used in each point with a depth of one to three millimeters and on two occasions of 0 and 7 days. Injections are performed using 5 cc disposable sterile syringes with a thin needle head (0.27 mm x 4 mm).Stretching exercises (for two weeks) and strengthening of wrist extensors (after two weeks) are used. The duration of each exercise is 15 to 30 seconds and is repeated 10 to 30 times a day according to the patient's tolerance. Intervention 2: The second intervention group: A special acupuncture needle with a size of 13 x 18 cm is used to perform acupuncture. The needle entry point is the acupuncture points Lu5, Li10, Li11, Li12 and points with maximum tenderness. The depth of needle insertion is selected according to the recommendations of traditional Chinese acupuncture for classic points and the needles are removed after 25 minutes. Acupuncture sessions are performed for 4 weeks and between 2 to 3 sessions per week (on average, each patient has at least 10 sessions during He is treated with acupuncture for 4 weeks.Stretching exercises (for two weeks) and strengthening of wrist extensors (after two weeks) are used. The duration of each exercise is 15 to 30 seconds and is repeated 10 to 30 times a day according to the patient's tolerance. Intervention 3: Control group: Oral naproxen tablets of 500 mg are used twice a day (once every twelve hours) for a period of 7 days.Stretching exercises (for two weeks) and strengthening of wrist extensors (after two weeks) are used. The duration of each exercise is 15 to 30 seconds and is repeated 10 to 30 times a day according to the patient's tolerance. Yes - There is a plan to make this available What will be shared: The results of completing the questionnaires on improving pain and function are published without mentioning the names and personal information of the patients. When: The access period starts after the results are printed To whom: Only for researchers working in academic and scientific institutions Conditions: Only data analysis in terms of quality of life improvement in tennis elbow patients is allowed. Where to obtain: malekmohammadi@sums.ac.ir How to obtain: 3 to 6 months after receiving the applicant's email Comments:
public Mahshid Malekmohamadi
No.6 Eram dormitory.,Eram square.,Shiraz
Shiraz Iran (Islamic Republic of) 7194685791 +98 34 3261 1443 malekmohammadi@sums.ac.ir Shiraz University of Medical Sciences scientific Mahshid Malekmohamadi
No.6 Eram dormitory.,Eram square.,Shiraz
Shiraz Iran (Islamic Republic of) 7194685791 +98 34 3261 1443 malekmohammadi@sums.ac.ir Shiraz University of Medical Sciences 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 local pressure and wrist extension against resistance Age between 25 and 70 years At least 3 months have passed since the onset of symptoms They have not responded to primary and conservative treatments 25 years 70 years Both Any clinical symptoms of effusion, inflammation, redness and warmth of the involved area Having uncontrolled diabetes, rheumatic diseases and vascular collagen, myopathy, any serious systemic and local infection, Brucella, bleeding diseases History of surgery in the elbow joint of the affected side Severe deformity of the upper limbs Inability to communicate and complete questionnaires History of allergies and allergic reactions to the drugs used, history of significant liver, kidney, brain and cardiopulmonary disorders, history of injections in or around the affected joint in the last 3 months, history of elbow and upper limb physiotherapy in the last 1 month Stable use of NASID in the last 48 hours Pregnant and lactating women, people with cancer People who are using anticoagulants M77.1 Lateral epicondylitis Treatment - Drugs Treatment - Devices Treatment - Drugs The first intervention group: to perform mesotherapy with piroxicam, we insert the needle into the skin at an angle of 10 degrees and horizontally. The needle entry point is the acupuncture points Lu5, Li10, Li11, Li12 and the maximum tenderness point, which is composed of one cc of piroxicam 20 mg. And 4 cc of 2% lidocaine is used in each point with a depth of one to three millimeters and on two occasions of 0 and 7 days. Injections are performed using 5 cc disposable sterile syringes with a thin needle head (0.27 mm x 4 mm).Stretching exercises (for two weeks) and strengthening of wrist extensors (after two weeks) are used. The duration of each exercise is 15 to 30 seconds and is repeated 10 to 30 times a day according to the patient's tolerance. The second intervention group: A special acupuncture needle with a size of 13 x 18 cm is used to perform acupuncture. The needle entry point is the acupuncture points Lu5, Li10, Li11, Li12 and points with maximum tenderness. The depth of needle insertion is selected according to the recommendations of traditional Chinese acupuncture for classic points and the needles are removed after 25 minutes. Acupuncture sessions are performed for 4 weeks and between 2 to 3 sessions per week (on average, each patient has at least 10 sessions during He is treated with acupuncture for 4 weeks.Stretching exercises (for two weeks) and strengthening of wrist extensors (after two weeks) are used. The duration of each exercise is 15 to 30 seconds and is repeated 10 to 30 times a day according to the patient's tolerance. Control group: Oral naproxen tablets of 500 mg are used twice a day (once every twelve hours) for a period of 7 days.Stretching exercises (for two weeks) and strengthening of wrist extensors (after two weeks) are used. The duration of each exercise is 15 to 30 seconds and is repeated 10 to 30 times a day according to the patient's tolerance. Intensity of pain. Timepoint: Before starting the treatment and 2 and 4 weeks after the treatment. Method of measurement: Visual Analog Scale. Performance. Timepoint: Before starting the treatment and 2 and 4 weeks after the treatment. Method of measurement: Patient-Rated Tennis Elbow Evaluation. Shiraz University of Medical Sciences Approved 2025-01-20 Ethics Committee of Shiraz University of Medical Sciences No.6 Eram dormitory, Eram square Shiraz Fars Iran (Islamic Republic of)