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IRCT20230821059204N2 IRCT 2023-10-12 Mazandaran University of Medical Sciences Effect of Dextrose Injection in Rotator Cuff Tendinopathy of The Shoulder A Comparative Study of the Effect of Two Concentrations of Dextrose Injection (12.5% And 25%) on Pain and Function of Patients with Rotator Cuff Tendinopathy of The Shoulder 2023-10-22 anticipated 66 Complete https://irct.ir/trial/72829 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In the first group, 2 ml of 25% dextrose Prolotherapy solution (containing 1 ml of 50% dextrose and 1 ml of 2% lidocaine) and in the second group 2 ml of 12.5% dextrose Prolotherapy solution (containing 0.5 ml of 50% dextrose and 1.5 ml of 2% lidocaine) will be injected. The control group will be exercise therapy, Randomization description: Randomization will be done using computer generated random numbers. Based on the selected numbers, the participants will be assigned to a 12.5% hypertonic dextrose prolotherapy group, another 25% hypertonic dextrose prolotherapy group, and a control group of exercise therapy. 3 Rotator cuff tendinopathy of the shoulder. Intervention 1: Intervention group 1: The injection will be performed under ultrasound guide by a sports medicine specialist. Patients will maintain an upright sitting position with shoulder extension, arm flexion, and hand to hip touch to obtain a longitudinal view of the supraspinatus tendon. A prolotherapy injection session will be performed under ultrasound guide in aseptic conditions using a 23-G needle to the insertion site of the supraspinatus tendon. In the first group, 2 ml of 25% Prolotherapy dextrose solution (containing 1 ml of 50% dextrose and 1 ml of 2% lidocaine) will be injected. Intervention 2: Intervention group 2: The injection will be performed under ultrasound guide by a sports medicine specialist. Patients will maintain an upright sitting position with shoulder extension, arm flexion, and hand to hip touch to obtain a longitudinal view of the supraspinatus tendon. A prolotherapy injection session will be performed under ultrasound guide in aseptic conditions using a 23-G needle to the insertion site of the supraspinatus tendon. In the first group, 2 ml of 12.5% Prolotherapy dextrose solution (containing 0.5 ml of 50% dextrose and 1.5 ml of 2% lidocaine) will be injected. Intervention 3: Control group: The control group will be given exercise therapy, which exercises will be given to the patient in a booklet, and they will be taught in each visit that the exercises in the first week include correcting the position of the scapula and the shrug of the scapula; in the second week includes external rotation at zero degrees; In the third week, it includes internal rotation at 0 degrees, and in the fourth week, it includes boat movement at 45 degrees, boat movement at 90 degrees, anterior shoulder stretching and trunk stretching in a sitting position. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hanieh Ahmadi
Sports Medicine Department, Mostafavian Clinic, Razi No. 3 Alley, Razi St.
Sari Iran (Islamic Republic of) 4816868890 +98 11 3336 6552 H.ahmadi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Hanieh Ahmadi
Sports Medicine Department, Mostafavian Clinic, Razi No. 3 Alley, Razi St.
Sari Iran (Islamic Republic of) 4816868890 +98 11 3336 6552 H.ahmadi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Adults (over 20 years) Chronic shoulder pain for more than six months Shoulder ultrasound of the supraspinatus tendon showing chronic tendinopathy such as a tear or tendinosis The average intensity of shoulder pain is more than 3 points on the ten-point Visual Analog Scale (VAS) Agreeing and complying with our study protocol The possibility of signing an informed consent form 20 years no limit Both Associated with adhesive capsulitis and limited range of motion of the shoulder Shoulder joint replacement Shoulder surgery or arthroscopy of the injured shoulder within the past year Injection of steroid, hyaluronic acid or platelet-rich plasma or any type of prolotherapy injection in the shoulder joint within the last three months Neurological disease that causes weakness on the affected side Impaired cognitive function and inability to complete the questionnaire Concurrent participation in another clinical trial S46.0 Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder Treatment - Drugs Treatment - Drugs Treatment - Other Intervention group 1: The injection will be performed under ultrasound guide by a sports medicine specialist. Patients will maintain an upright sitting position with shoulder extension, arm flexion, and hand to hip touch to obtain a longitudinal view of the supraspinatus tendon. A prolotherapy injection session will be performed under ultrasound guide in aseptic conditions using a 23-G needle to the insertion site of the supraspinatus tendon. In the first group, 2 ml of 25% Prolotherapy dextrose solution (containing 1 ml of 50% dextrose and 1 ml of 2% lidocaine) will be injected. Intervention group 2: The injection will be performed under ultrasound guide by a sports medicine specialist. Patients will maintain an upright sitting position with shoulder extension, arm flexion, and hand to hip touch to obtain a longitudinal view of the supraspinatus tendon. A prolotherapy injection session will be performed under ultrasound guide in aseptic conditions using a 23-G needle to the insertion site of the supraspinatus tendon. In the first group, 2 ml of 12.5% Prolotherapy dextrose solution (containing 0.5 ml of 50% dextrose and 1.5 ml of 2% lidocaine) will be injected. Control group: The control group will be given exercise therapy, which exercises will be given to the patient in a booklet, and they will be taught in each visit that the exercises in the first week include correcting the position of the scapula and the shrug of the scapula; in the second week includes external rotation at zero degrees; In the third week, it includes internal rotation at 0 degrees, and in the fourth week, it includes boat movement at 45 degrees, boat movement at 90 degrees, anterior shoulder stretching and trunk stretching in a sitting position. Average score in the Shoulder Pain and Disability Index (SPADI) of the injured shoulder. Timepoint: At the beginning of the study before the start of the intervention and at the end of the second and sixth weeks after the intervention. Method of measurement: The Shoulder Pain and Disability Index (SPADI) is a self-administered assessment tool used to measure shoulder pain and disability. It has five pain items and eight disability items measured on the Visual Analogue Score. Pain and disability subscales are calculated as the mean of the corresponding items on a 0-100 scale, with the highest score indicating the most severe pain and disability. In this study, the total outcome score used for statistical analysis will be calculated as the sum of pain and disability subscales. Active range of motion of the shoulder. Timepoint: At the beginning of the study before the start of the intervention and at the end of the second and sixth weeks after the intervention. Method of measurement: Active shoulder range of motion, i.e., forward flexion, internal rotation, external rotation, and abduction in standing position, will be assessed using a goniometer. Patients will move their shoulders slowly until they reach an angle at which pain is felt, and this movement will be performed three times to record the average value of the angle. Supraspinatus tendon thickness. Timepoint: At the beginning of the study before the start of the intervention and at the end of the second and sixth weeks after the intervention. Method of measurement: Using ultrasound, the maximum thickness of the supraspinatus tendon will be measured in millimeters. Mazandaran University of Medical Sciences Approved 2023-04-19 Ethics Committee of Mazandaran University of Medical Sciences, Imam Hospital Serah Joibar, the beginning of Vali Asr Highway, the headquarters of Mazandaran University of Medical Sciences and Health Services Sari Mazandaran Iran (Islamic Republic of)