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IRCT20191015045119N1 IRCT 2020-04-05 Tehran University of Medical Sciences Ultasound use effect in thumb injection Comparison of the therapeutic efficacy between corticosteroid injection with and without ultrasound guidance among patients with carpometacarpal 1 joint osteoarthritis 2019-10-15 anticipated 40 Complete https://irct.ir/trial/45039 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups by using the four block randomization method. This method uses two letters A and B in which the letter A represents the patient in the first group (blind) and the letter B in the second group (ultrasound). Then two letters A and B will be written on some papers in six different arrangements, BAAB, AABB, ABAB, BBAA, ABBA, BABA. we will randomly pick one of the papers and place the patients in order, according to the larrangement of the A and B letters. We will continue untile we achieve the desired sample size, Blinding description: Ultrasound probes will be used in both groups and the device is switched on. In group A, the probe is not connected to the device while it is connected in group B. The patient is placed behind the monitor and does not know whether the probe is connected or not. 3 Osteoarthritis of the first carpometacarpal joint. Intervention 1: Intervention group 1 (Carpometacarpal joint injection under ultrasound guide): In this group, after diagnosis, patients will be treated with corticosteroid injection into the 1st CMC joint under US guidance. After sterilizing the skin, the injection will be done with a 3-5 CC syringe and 27-25 Gauge needle and 1-1.5 inches in length, from the dorsal surface of the 1st CMC joint with 60 ° angle of the needle and in-plane probe from distal to proximal, entering the articular space. After aspiration, injection of 40 mg methylprednisolone with 0.5CC 2% lidocaine will be done. Intervention 2: Intervention group 2 (Carpometacarpal joint injection with anatomic landmarks): In this group, after diagnosis, patients will be treated with corticosteroid injection into the 1st CMC joint using anatomic landmarks. After sterilizing the skin, the injection will be done with a 3-5 CC syringe and 27-25 Gauge needle and 1-1.5 inches in length, from the dorsal surface of the 1st CMC joint with 60 ° angle of the needle , entering the articular space. After aspiration, injection of 40 mg methylprednisolone with 0.5CC 2% lidocaine will be done. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The decision will be made after the study.
public Maryam Hosseini
Imam Khomeini hospital, Dr. Gharib street, at the end of Kheshavarz boulevard
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2291 m_hosseini100@yahoo.com Tehran University of Medical Sciences scientific Maryam Hosseini
Imam Khomeini hospital, Dr. Gharib street, at the end of Kheshavarz boulevard
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2291 m_hosseini100@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age at least 18 years old History of pain of first CMC joint during rest or activity that has last for at least 3 months Have VAS score at least 3 before entering the study Pain during touch of the dorsal surface of the CMC OA radiographic evidence of reduced articular space or osteophyte formation (grade 2,3) No response to common osteoarthritis treatments including oral and topical skin treatments, physiotherapy, exercise therapy, contrast bath 18 years no limit Both No patient access for post-intervention investigation due to no personal referral Patient's willing to use systemic steroids or intra-articular injection other than injectable drugs under the study Radiographic evidence of severe osteoarthritis (grade 4) Previous history of first carpometacarpal surgery History of any intra-CMC1 joint injection in the past six months Use of physiotherapy modality during the last 3 months Presence of steroid / lidocain injection contraindication such as sensitivity to these drugs and infection at the site of injection presence of a risk factor for intra-articular injection such as anti-coagulation use Poor control of diabetes, coagulation diseases, fractures, rheumatologic diseases, tumors, infections, gout, pregnancy or decision to get pregnant Severe deformity of the joint Acute trauma (last 3 months) M18.9 Osteoarthritis of first carpometacarpal joint, unspecified Treatment - Drugs Treatment - Drugs Intervention group 1 (Carpometacarpal joint injection under ultrasound guide): In this group, after diagnosis, patients will be treated with corticosteroid injection into the 1st CMC joint under US guidance. After sterilizing the skin, the injection will be done with a 3-5 CC syringe and 27-25 Gauge needle and 1-1.5 inches in length, from the dorsal surface of the 1st CMC joint with 60 ° angle of the needle and in-plane probe from distal to proximal, entering the articular space. After aspiration, injection of 40 mg methylprednisolone with 0.5CC 2% lidocaine will be done. Intervention group 2 (Carpometacarpal joint injection with anatomic landmarks): In this group, after diagnosis, patients will be treated with corticosteroid injection into the 1st CMC joint using anatomic landmarks. After sterilizing the skin, the injection will be done with a 3-5 CC syringe and 27-25 Gauge needle and 1-1.5 inches in length, from the dorsal surface of the 1st CMC joint with 60 ° angle of the needle , entering the articular space. After aspiration, injection of 40 mg methylprednisolone with 0.5CC 2% lidocaine will be done. Pain severity. Timepoint: At baseline and 2, 6, and 12 weeks after injection. Method of measurement: Visual Analogue Scale (VAS). Hand functional ability. Timepoint: At baseline and 2, 6, and 12 weeks after injection. Method of measurement: FIHOA questionnaire. Upper limb disability. Timepoint: At baseline and 2, 6, and 12 weeks after injection. Method of measurement: Quick-DASH Questionnaire. Pinch power which is the power of thumb to squeeze something. Timepoint: At baseline and 2, 6, and 12 weeks after injection. Method of measurement: Dynamometer. Tehran University of Medical Sciences Approved 2019-10-14 Ethics Committee on Biological Research Imam Khomeini Hospital, Dr.Gharib Street, at the end of Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)