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IRCT20230316057742N2 IRCT 2024-04-30 Babol University of Medical Sciences Investigation of three injection methods under ultrasound guidance inside the shoulder joint in patients with frozen shoulder Comparison of the effectiveness of three methods of injection under ultrasound guidance inside the shoulder joint and hydrodistension of the shoulder joint and suprascapular nerve block on shoulder function in patients with frozen shoulder. 2024-05-21 anticipated 102 Complete https://irct.ir/trial/76183 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, the data analyst and the result evaluator and the participant are blinded. Due to the same treatment method (injection) and the same color of injectable drugs and the same injection site in all three groups, the possibility of blinding at the participant level is also possible. N/A Adhesive capsulitis of shoulder. Intervention 1: After the diagnosis of frozen shoulder by the orthopedist in the clinic, the patients refer to the operating room for injection and are randomly divided into three groups. For injection, a gray spine needle number 27 is used. The exact location of the injection is determined using an ultrasound guide, and the desired drugs are 2% lidocaine ampoule from Caspin Tamin Company, 40 mg methylprednisolone acetate ampoule from Elixir Company, and distilled water from Shahid Ghazi Company. Only one injection is given to the patients and then they undergo follow-up for 24 weeks, which will include 5 examinations. Once upon entering the clinic, then 2 weeks after the injection, 6 weeks after the injection, 12 weeks after the injection, and 24 weeks after the injection, the patients are examined. Group A, in which the injection under ultrasound guidance inside the shoulder joint in the form of hydrodistention, which includes (5 cc of distilled water, 5 cc of 2% lidocaine hydrochloride) will be injected into the patient's shoulder. Intervention 2: Intervention group: Intervention group B: intra-articular injection (5 cc lidocaine hydrochloride 2% + 1 cc methylprednisolone 40 mg + 4 cc distilled water). Intervention 3: Intervention group: Intervention group C: Suprascapular nerve block (2 cc lidocaine hydrochloride 2% + 1 cc prednisolone 40 mg + 2 cc distilled water). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The time of data release is one year after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions and orthopedic specialist colleagues Conditions: Other than the above conditions, there is no specific limitation in the data Where to obtain: To Dr. Khalilzad, knee specialist, faculty of Babol University of Medical Sciences 09143822836 How to obtain: majidkhalizad@yahoo.com Dr. Khalilzad, orthopedic specialist Comments:
public yasin sharifzadeh
Babol,shahid beheshti hospital
Babol Iran (Islamic Republic of) 5151524525 +98 11 3225 7896 dryasinsharifzadeh@gmail.com Babol University of Medical Sciences scientific yasin sharifzadeh
Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St ,
Babol Iran (Islamic Republic of) 4716681451 +98 11 3225 2071 dryasinsharifzadeh@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of ice shoulder by an orthopedic doctor Failure to respond to non-invasive treatments such as physiotherapy and drug therapy Active and passive reduction of rom movements Age between 18-60 years 18 years 60 years Both known systemic diseases such as rheumatoid arthritis History of recent trauma or surgery or known chronic disease (such as rotator cuff lesions) Pivacaine, any known systemic disease Midclavicular joint, cervical radiculopathy Brachial plexopathy, neoplasm pregnancy Addiction to opioids diabetes Osteoarthritis M75.0 Adhesive capsulitis of shoulder Treatment - Drugs Treatment - Drugs Treatment - Drugs After the diagnosis of frozen shoulder by the orthopedist in the clinic, the patients refer to the operating room for injection and are randomly divided into three groups. For injection, a gray spine needle number 27 is used. The exact location of the injection is determined using an ultrasound guide, and the desired drugs are 2% lidocaine ampoule from Caspin Tamin Company, 40 mg methylprednisolone acetate ampoule from Elixir Company, and distilled water from Shahid Ghazi Company. Only one injection is given to the patients and then they undergo follow-up for 24 weeks, which will include 5 examinations. Once upon entering the clinic, then 2 weeks after the injection, 6 weeks after the injection, 12 weeks after the injection, and 24 weeks after the injection, the patients are examined. Group A, in which the injection under ultrasound guidance inside the shoulder joint in the form of hydrodistention, which includes (5 cc of distilled water, 5 cc of 2% lidocaine hydrochloride) will be injected into the patient's shoulder. Intervention group: Intervention group B: intra-articular injection (5 cc lidocaine hydrochloride 2% + 1 cc methylprednisolone 40 mg + 4 cc distilled water) Intervention group: Intervention group C: Suprascapular nerve block (2 cc lidocaine hydrochloride 2% + 1 cc prednisolone 40 mg + 2 cc distilled water) Score obtained on the Shoulder Pain and Disability Index. Timepoint: Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention. Method of measurement: Shoulder Pain and Disability Index. Score obtained on the Pittsburgh Sleep Quality Questionnaire. Timepoint: Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention. Method of measurement: Pittsburgh Sleep Quality Index. Visual Analogue Pain Scale. Timepoint: Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention. Method of measurement: Score obtained on the visual analog scale. Shoulder Internal Rotation Movement Scale score. Timepoint: Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention. Method of measurement: Score obtained based on the goniometer device. Shoulder external rotation movement scale score. Timepoint: Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention. Method of measurement: Score obtained based on the goniometer device. Shoulder abduction range of motion score. Timepoint: Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention. Method of measurement: Score obtained based on the goniometer device. Shoulder flexion movement scale. Timepoint: Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention. Method of measurement: Score obtained based on the goniometer device. Time to recovery. Timepoint: At follow-up times every week after the intervention. Method of measurement: Recovery of maximum shoulder ROM based on goniometry and absence of pain based on visual analog scale (VAS). Babol University of Medical Sciences Approved 2024-03-06 Ethics committee of Babol University of Medical Sciences Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St , Babol babol Mazandaran Iran (Islamic Republic of)