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IRCT20130523013442N31 IRCT 2022-12-20 Shahid Beheshti University of Medical Sciences Comparison of ultrasound-guided corticosteroid and botulinum toxin in frozen shoulder Comparison of ultrasound-guided corticosteroid and botulinum toxin in frozen shoulder 2022-09-11 anticipated 60 Complete https://irct.ir/trial/65681 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: in this clinical trial study, 60 patients with a diagnosis of frozen shoulder will be included in the study randomly .For random allocation of individuals in the study groups (intervention or intervention group and comparison or comparison group), the method of random allocation with block method (Block Randomization) will be used In this method, blocks with size of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1: 1 will be used. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified with two type of cards which are including group a (intervention group) and b (comparison group) and these cards are placed inside 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, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined, 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 200 units of botulinum toxin (Masport, Masson Darou) and 1 cc of lidocaine intra-articularly. Intervention 2: Control group: Includes 30 patients who are treated with triamcinolone (40 mg ) with 1 cc of lidocaine (2%) intra-articularly. 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 ali.nazari32@yahoo.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 ali.nazari32@yahoo.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 30 to 60 years Diagnosed with adhesive capsulitis based on history and physical examination No response to conservative treatments, including non-steroidal anti-inflammatory drugs, opioids, exercise therapy, and physical therapy. A score of 5 or higher based on the intensity of the pain (according to the VAS criteria) Less than 6 months have passed since the onset of the symptoms Have more than 30 degree reduction in the range of motion in at least 2 of the 4 directions of motion (abduction, flexion, external rotation, and internal rotation) compared to the range of motion of the healthy shoulder (opposite side) 30 years 60 years Both History of shoulder trauma in the last 6 months History of humerus fracture Pregnancy and breastfeeding The presence of nerve damage or neurological disorders that cause dysfunction of the upper limbs, including brachial plexopathy, hemiplegia, and peripheral nerve damage. Allergy or known sensitivity to botulinum toxin or corticosteroids Presence of 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 intra-articular injection in the last 6 months Inflammatory systemic diseases Use of anticoagulants The presence of diseases that involve the connection between nerve and muscle, such as myasthenia gravis and Eaton Lambert M75.0 Adhesive capsulitis of shoulder Treatment - Drugs Treatment - Drugs Intervention group: Includes 30 patients who are treated with 200 units of botulinum toxin (Masport, Masson Darou) and 1 cc of lidocaine intra-articularly. Control group: Includes 30 patients who are treated with triamcinolone (40 mg ) with 1 cc of lidocaine (2%) intra-articularly. Active range of motion of shoulder. Timepoint: At the beginning of the study (before intervention) and 6 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 6 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 6 weeks and 24 weeks after the intervention. Method of measurement: Oxford Shoulder Score (OSS). Shahid Beheshti University of Medical Science Approved 2022-07-24 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)