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IRCT20101113005172N4 IRCT 2018-10-24 Shahid Beheshti University of Medical Sciences Comparison of therapeutic effect of prolotherapy by glucose, corticosteroid and physical therapy in shoulder teddinopathy Evaluation of the efficacy of three different methods in the treatment of rotator cuff tendinopathy of shoulder; Dextrose-prolotherapy, Corticosteroid injections and Physical therapy. 2018-10-23 anticipated 114 Complete https://irct.ir/trial/34512 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the arrival of patients in each of the three study groups, a restriced randomization method using the random allocation rule will be done.This randomization method is used to balance the number of people assigned to each of the groups at the end of the sample collection. In this study, taking into account 38 patients for each group, a total of 120 patients will be considered for entry and randomization. In this method, 120 small balls of the same size are considered in three different colors; 30 yellow balls representing prolethropopy, 30 blue balls representing corticosteroids and 30 green balls representing physical therapy. All small balls are placed in a bag and for each patient, a ball is pulled out of the bag, Blinding description: At the begining of the study, all patients in the three groups will be injected in the same place. Post-injection care is the same in all three groups. The only difference is in patients with the "physical therapy" group, which physical therapies will start 1 week after the injection. It is worth noting that patients in any of the three groups are not aware of the content of the injections. The collecting person as well as the person analyzing the data are not aware of the patient's treatment method. 3 Injury or partial tearing of rotator cuff tendons of the shoulder. Intervention 1: Intervention group 1: Prolotherapy by dextrose. In this group, after placing the patient in the sitting position, 8 cc of dextrose solution 12.5% containing 40 mg lidocaine will be injected in the 3 to 5 points around the shoulder joint (adjacent to the supraspinatus and subscapularis tendons, and other points with tenderness Around the joint) with a 25 gauge, 3.5 cm needle. Intervention 2: Intervention group 2: Corticosteroid injection. In this group, after placement of the patient in the sitting position and under ultrasound guide, 8 cc of 0.1% lidocaine solution containing 80 mg of triamcinolone will be injected in the area adjacent to the supraspinatus and subscapularis tendons (Needle gauge 25, cm5) and around the suprascapular nerve (Needle, 9 cm , 23 gauge). Intervention 3: Intervention group 3: Physical therapy. In this group, after placement of the patient in the sitting position and under ultrasound guide, 8 cc of lidocaine solution 1% will be injected in the area adjacent to the supraspinatus and subscapularis tendons (Needle 25 gauge, 5 cm) and around the suprascapular nerve (spinal needle 23 gauge, 9 cm), and after 1 week, the patient will undergo 10 sessions of physical therapy [every other day] with Tense, Ultrasound and Hot Pack modalities. Yes - There is a plan to make this available What will be shared: The individual data of the participants in the research, after being unidentifiable When: Start the access period, 6 months after printing the results To whom: Academic researchers Conditions: To be used in medical researches Where to obtain: Saman Asadi asadisa60@gmail.com How to obtain: Official application through academic or research centers Comments:
public Saman Asadi
Pain clinic, Imam Hossein hospital, Shahid Madani Ave., Imam Ali Blvd.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 asadisa60@gmail.com Shahid Beheshti University of Medical Sciences scientific Mehrdad Taheri
Pain clinic, Imam Hossein hospital, Shahid Madani Ave., Imam Ali Blvd.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 taheri.1352@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Shoulder pain for at least 6 weeks Rotator cuff tendinopathy has been confirmed by physical examination and imaging methods Patient between 18-65 years old 18 years 65 years Both Past history of shoulder surgery Diabete mellitus Malignancy Immune insufficiency disorders M67.9 Unspecified disorder of synovium and tendon Treatment - Other Treatment - Other Treatment - Other Intervention group 1: Prolotherapy by dextrose. In this group, after placing the patient in the sitting position, 8 cc of dextrose solution 12.5% containing 40 mg lidocaine will be injected in the 3 to 5 points around the shoulder joint (adjacent to the supraspinatus and subscapularis tendons, and other points with tenderness Around the joint) with a 25 gauge, 3.5 cm needle. Intervention group 2: Corticosteroid injection. In this group, after placement of the patient in the sitting position and under ultrasound guide, 8 cc of 0.1% lidocaine solution containing 80 mg of triamcinolone will be injected in the area adjacent to the supraspinatus and subscapularis tendons (Needle gauge 25, cm5) and around the suprascapular nerve (Needle, 9 cm , 23 gauge). Intervention group 3: Physical therapy. In this group, after placement of the patient in the sitting position and under ultrasound guide, 8 cc of lidocaine solution 1% will be injected in the area adjacent to the supraspinatus and subscapularis tendons (Needle 25 gauge, 5 cm) and around the suprascapular nerve (spinal needle 23 gauge, 9 cm), and after 1 week, the patient will undergo 10 sessions of physical therapy [every other day] with Tense, Ultrasound and Hot Pack modalities. Pain scale and disability in patients with injury or partial tearing of rotator cuff tendons of the shoulder. Timepoint: Measure the pain and disability of the shoulder joint at the beginning of the study (before the intervention) and one week, one month and three months after the end of the treatment interventions. Method of measurement: "Numerical Rating Scale" and "Shoulder Pain And Disability Index". Shahid Beheshti University of Medical Sciences Approved 2018-10-02 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Aerabi Ave., Yaman Blvd., Shahid Chamran Blvd. Tehran Tehran Iran (Islamic Republic of)