Comparison of the efficacy of platelet-rich plasma with corticosteroid in the Treatment of patients with frozen shoulder

Evaluation of the efficacy of platelet-rich plasma injection compared to corticosteroid injection in patients with frozen shoulder

Clinical trial with control group, with parallel groups, double blind, randomized, phase 3 on 75 patients. Excel software rand function was used for randomization.

Patients with frozen shoulder disease referred to the Shafa Yahyaian Hospital will be randomly assigned into the three groups: platelet-rich plasma injection, corticosteroid injection, and normal saline injection. The efficacy of platelet-rich plasma will be compared with that of corticosteroids. The participant, the injector, and the outcome evaluator will not be informed of the treatment offered to the patients.

Inclusion criteria: Diagnosis of frozen shoulder disease by an orthopedic surgeon Age 18 to 80 years Providing Inform consent to participate in the study Exclusion criteria: History of frozen shoulder Other shoulder-related diseases include calcified tendonitis, rotator cuff arthropathy, severe osteoarthritis of the shoulder, or a history of recurrent or late shoulder dislocation History of shoulder surgery Accompanying musculoskeletal patients including severe osteoarthritis, rheumatoid arthritis, fibromyalgia, and etc. Recent development of severe psychiatric disorders such as psychosis, mania, suicide and major cognitive impairment depression such as mental retardation or dementia

The first intervention group will receive 8 ml of platelet-rich plasma intra-articularly. The second intervention group will receive 2 ml of methylprednisolone acetate (40 mg) combined with 2 ml of 2% lidocaine and 11 ml of normal saline intra-articularly. The control group will receive 13 ml of normal saline combined with 2 ml of 2% lidocaine internally.

Shoulder pain, Shoulder function

Simple randomization with Excel RAND function will be implemented. To create a random chain of 3 groups of 25, in a column, 25 letters A, 25 letters B, ‎and 25 letters C, and in the adjacent column, 75 random numbers are made by order of RAND. The ‎composition of both columns is arranged based on the random numbers from large to small. The ‎sequence of letters A, B, and C is used‏.‏ These numbers are placed in opaque envelopes, and one envelope is assigned to each patient. Finally, the envelope is opened and the assigned treatment group is identified.

Participating patients and injectors will be blind to the type of treatment used for each patient. To ‎blind patients, they will be told that they will receive one of three treatments: corticosteroids, ‎platelet-rich plasma, or normal saline. To blind the injector, the solution is first drawn into a syringe in ‎another room by a trained nurse and covered with a label on the syringes so that the difference of ‎liquid inside is not clear. The ready for injection syringe is then handed to the doctor for injection.‎

All data is potentially shareable after unidentified individuals

Start of access period from 1402

The data of this study will be available only to researchers working in academic and scientific institutions

The data will be available if the request is sent to the email of the project manager, and any kind of analysis of the data is allowed.

To receive the data, Dr. Pouria Tabrizian should be contacted through the following ways: Postal Address: ddressShafa Yahyaeian Hospital, In front of the gas station, Mojahedine-Islam Ave, Shohada Sq P.O BOX:1157637131‎ Telephone: 0098 21 33542041 Fax: 0098 21 33542020 Mobile: 0098 9155216214‎ Email: tabrizian.pouria@gmail.com

After sending an email to request the documents and reviewing the request by the project executor, the applicant will refer to the introduced center with the identification documents on the specified date and receive the documents.