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IRCT20130523013442N32 IRCT 2023-09-13 Shahid Beheshti University of Medical Sciences Comparison of ultrasound guided injection of hyaluronic acid, hyaluronidase enzyme and triamcinolone in the treatment of frozen shoulder Comparison of ultrasound guided injection of hyaluronic acid, hyaluronidase enzyme and triamcinolone in the treatment of frozen shoulder 2023-09-23 anticipated 90 Complete https://irct.ir/trial/72510 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: In this clinical trial study, 90 patients diagnosed with frozen shoulder will be randomly enrolled. Block randomization method will be used for random allocation of people in the studied groups. In this method, blocks of 9 will be used with a ratio of 1:1:1. Random Allocation software will be used to generate random sequences. For concealment, random allocation concealment method will be used, which is marked with the letters A (Hyalase receiving group), B (Triamcinolone receiving group) and C (Hyaluronic acid receiving group) and recorded on cards. These cards will be placed in the sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then based on The order of entry of the eligible participants, the envelopes will be opened and the assigned group of that participant will be known, Blinding description: The researcher, patients and the collaborator of the project who will perform ‎the statistical analysis will not be aware of the study . grouping of patients will ‎be noted and will be shared to one of the partners ‎. 3 Adhesive capsulitis or Frozen shoulder. Intervention 1: Intervention group: Includes 30 patients who are treated with hyalase injection at the rate of 1500 units in 5 cc of normal saline along with 2 cc of 2% lidocaine. Intervention 2: Intervention group: Includes 30 patients who are treated with triamcinolone injection in the amount of 40 mg (one cc) along with 4 cc of normal saline and 2 cc of 2% lidocaine. Intervention 3: Intervention group: Including 30 patients who are treated with 2.5 cc of hyaluronic acid (20 mg per cc) along with 2.5 cc of normal saline and 2 cc of lidocaine. Yes - There is a plan to make this available What will be shared: All the data of people participating in this study can be shared after deidentifying people When: The access period starts one year after the results are published To whom: Data of this study will be available to researchers working in academic and scientific institutions Conditions: If the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers. Where to obtain: By sending an email to alin7093@gmail.com How to obtain: Sending an e-mail and explaining the purpose and how to use the data Comments:
public Ali Nazari Nodoushan
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 alin7093@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Ahmad Raeissadat
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 a_raeissadat@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People aged 25 to 70 years have been diagnosed with adhesive capsulitis based on history and physical examination and did not respond to conservative treatments including non-steroidal pain relievers, exercise therapy and physical modalities. According to VAS criteria, they have scored 5 or higher. More than 30 degrees restriction of shoulder active range of motion in at least 2 of 4 directions of motion (abduction, flexion, external rotation and internal rotation) compared to the range of motion of the healthy shoulder (opposite side). Less than 6 months have passed since the onset of symptoms. 25 years 70 years Both History of shoulder trauma in the last 6 months History of humerus bone fracture, supraspinatus tear, subacromial bursitis, calcific tendonitis and acromioclavicular joint osteoarthritis Pregnancy and breastfeeding. The presence of nerve injury or the presence of neurological disorders that cause dysfunction of the upper limbs, including brachial plexus plexopathy, hemiplegia and peripheral nerve injury Known allergy or sensitivity to hyalase, hyaluronic acid, or corticosteroids Psychological problems History of shoulder surgery A patient who is unable to cooperate to check the range of motion due to severe pain History of shoulder intra-articular injection of corticosteroids and hyaluronic acid in the last 6 months Inflammatory systemic diseases, hypothyroidism, hyperthyroidism and diabetes Use of anticoagulants M75.0 Adhesive capsulitis of shoulder Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Includes 30 patients who are treated with hyalase injection at the rate of 1500 units in 5 cc of normal saline along with 2 cc of 2% lidocaine. Intervention group: Includes 30 patients who are treated with triamcinolone injection in the amount of 40 mg (one cc) along with 4 cc of normal saline and 2 cc of 2% lidocaine. Intervention group: Including 30 patients who are treated with 2.5 cc of hyaluronic acid (20 mg per cc) along with 2.5 cc of normal saline and 2 cc of lidocaine Active range of motion of shoulder. Timepoint: At the beginning of the study (before intervention) and 8 weeks and 24 weeks after the intervention. Method of measurement: Digital goniometer. Assessment of shoulder pain. Timepoint: At the beginning of the study (before intervention) and 8 weeks and 24 weeks after the intervention. Method of measurement: Visual analogue scale (VAS). Assessment of the patient's performance in daily tasks. Timepoint: At the beginning of the study (before intervention) and 8 weeks and 24 weeks after the intervention. Method of measurement: Oxford Shoulder Score (OSS). The degree of patient's satisfaction with the treatment. Timepoint: At the beginning of the study (before intervention) and 8 weeks and 24 weeks after the intervention. Method of measurement: 5-items questionnaire. Laser Research Center, Shahid Beheshti University of Medical Sciences Approved 2023-08-09 Research Ethics Committees of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)