Comparison of the effect of ultrasound guided intra-articular injection of corticosteroids and platelet-riched plasma in the treatment of rotator cuff tendinopathy

Comparison of the effect of ultrasound guided intra-articular injection of corticosteroids and platelet-riched plasma in the treatment of rotator cuff tendinopathy

A double-blind clinical trial on 60 patients, simple randomization using the random numbers table, phase 3, with two parallel case and control groups.

In this double-blind clinical trial study, all patients diagnosed with tendinopathy without complete tendon rupture who refer to Shahid Beheshti Hospital are included in the study.

Inclusion criteria: shoulder pain for more than three months, tendinopathy and partial tear of rotator cuff tendons, MRI findings of tendinopathy or incomplete rotator cuff tear and exclusion criteria: complete tear of cuff tendons, history of shoulder surgery in 6 In the last month, the presence of rheumatological inflammatory diseases, the presence of shoulder instability based on examinations, the history of corticosteroid injection in the shoulder joint during the past 3 months, the history of PRP treatment in the past 6 months, the lack of patient satisfaction.

In the first group of PRP injections, by taking 35 cc of venous blood with 5 cc of EDTA, it was divided equally into 4 tubes, and the first round was performed for 10 minutes at a speed of 1600 rpm, and then the plasma It enters two pipes and the second round is done at a speed of 3500 rpm for 6 minutes. In this case, 6 cc of liquid containing platelets with a concentration of 5 to 6 times is obtained, which is divided into two syringes in the amount of 3 cc. 3 cc of it is injected intra-articularly at an angle of 30-45 degrees from posterolateral. The second group receives corticosteroid injection in the form of methylprednisolone 40 mg intra-articularly.

Shoulder pain and range of motion

People included in the study will be randomized by simple random method. Tables of random numbers found in many statistical reference books will be used to randomize the numbers. Numbers between 0 and 24 are assigned to the first group, numbers between 25 and 49 are assigned to the second group. The study group includes Cortone and PRP. Concealment is done in consecutively numbered, sealed, opaque envelopes and is kept by the department secretary.

This study is a double-blind clinical trial in which the participant, the outcome assessor and the data analyst will be unaware of the treatment process. After randomization, the patients of each treatment group are introduced by researcher 1 (one of the executive residents) to researcher 2 to evaluate the outcome. Researcher 2 (one of the supervisors) is only an outcome assessor and records the results without knowing the type of treatment and its effects. A person who is an information analyst (statistician) also receives the recorded information at the end of the work and is not in the process of the intervention groups in any way. Patients also do not know about the injectable substance. Blood is taken from all patients. Plasma in two intervention groups is drawn in a covered syringe.

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