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IRCT20240729062578N2 IRCT 2026-01-27 Shahid Beheshti University of Medical Sciences Safety and effectiveness of Botox injections combined with cortisone in shoulder tendon problems comparison of the safety and efficacy of botulinum toxin A injection combined with corticosteroids with corticosteroids with palcebo in the treatment of patients with supraspinatus tendinopathy 2026-02-24 anticipated 20 Complete https://irct.ir/trial/87813 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 20 patients with supraspinatus tendinopathy will be enrolled in a simple randomization study. To randomly assign individuals to the study groups (intervention group and comparison group), a block randomization method will be used. In this method, blocks of 2 (including one person in the intervention group and one person in the comparison group) will be used in a 1:1 ratio. Random Allocation software will be used to generate random sequences. Individuals will be divided into two intervention groups (10 people) and a control group (10 people). In the intervention group, 30 units of botulinum toxin A along with 40 units of steroid will be injected into the tendon sheath of the supraspinatus muscle. In the control group (placebo), 30 units of normal saline will be injected into the supraspinatus muscle and 40 units of steroid will be injected into the tendon sheath of the supraspinatus muscle. The injecting physician will not know about the substance injected into the muscle. Patients are also aware of the study conditions before the study, but during the study they do not know which group they are in and whether they will receive botulinum toxin in addition to the corticosteroid, Blinding description: Because there is no difference in volume, color, or appearance between normal saline and botulinum toxin, there is no need to cover the syringe Information about the contents of the syringe is not given to the patient or therapist. 2-3 Supraspinatus tendinopathy. Intervention 1: Intervention group: One injection of 30 units of Dysport into the supraspinatus muscle and 40 mg of methylprednisolone into the bursa of the supraspinatus tendon sheath once. Intervention 2: Control group: one injection of 40 mg of methylprednisolone into the bursa of the supraspinatus tendon sheath and 30 units of normal saline into the supraspinatus muscle once. No - There is not a plan to make this available Justification or reason for not sharing IPD is Patients are unwilling to disclose their information.
public Seyed Mansoor raygani
Darband Alley, Shahrdari Street
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2352 3710 mahboobeghanbarian313@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Mansoor raygani
Shohadaye Tajrish Hospital, Darband Avenue, Shahrdari Street
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2352 3710 mahboobeghanbarian313@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with supraspinatus tendinopathy Confirmation of the problem by examination and ultrasound Not having previously received treatment Intervention should be carried out as a first line Age between 20-70 years 20 years 70 years Both History of trauma to the hand and shoulder area in the last 6 months History of humerus fracture Complete rupture of the supraspinatus tendon Acromioclavicular joint osteoarthritis Calcific tendonitis Pregnancy and breastfeeding Presence of nerve damage or neurological disorders that cause upper limb dysfunction The existence of psychological problems History of shoulder surgery Patient's lack of cooperation in assessing range of motion History of corticosteroid injection into the shoulder within the past 6 months Concomitant radiculopathy Coincidence with frozen shoulder Systemic inflammatory diseases History of sensitivity to botulonium toxin History of sensitivity to corticosteroid M75.9 Shoulder lesion, unspecified Treatment - Drugs Treatment - Drugs Intervention group: One injection of 30 units of Dysport into the supraspinatus muscle and 40 mg of methylprednisolone into the bursa of the supraspinatus tendon sheath once Control group: one injection of 40 mg of methylprednisolone into the bursa of the supraspinatus tendon sheath and 30 units of normal saline into the supraspinatus muscle once Shoulder range of motion. Timepoint: Before injection,1and 3 months later. Method of measurement: Physical exam and questioner. Shoulder pain. Timepoint: Before injection,1and 3 months later. Method of measurement: Questioner. Quality of life. Timepoint: Before injection,1and 3months later. Method of measurement: Questioner. Shahid Beheshti University of Medical Sciences Approved 2025-10-23 Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Koodakya Alley, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)