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IRCT20250718066536N2 IRCT 2025-08-18 Islamic Azad University Comparing PRP, Corticosteroid, and Combined Therapy for Frozen Shoulder in People With or Without Diabetes PRP-CS-FS A Randomized Controlled Trial Comparing Platelet-Rich Plasma, Corticosteroid Injections, and Combination Therapy in Patients with Idiopathic and Diabetic Adhesive Capsulitis 2025-09-23 anticipated 100 Complete https://irct.ir/trial/85506 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized controlled trial with three parallel intervention groups. Outcome assessor blinded to group allocation, Randomization description: Randomization was performed using simple randomization at the individual level. The allocation process was carried out by an independent person who was not involved in the intervention. The random sequence list was generated using statistical software and random number generation. Allocation sequences were kept in opaque, sealed envelopes and were opened at the time of each participant’s enrollment to ensure allocation concealment. Upon enrollment, participants were assigned to one of the three treatment groups according to the random sequence, Blinding description: The outcome assessor was blinded to the group allocation. The person who recorded the outcome data was different from the intervention provider and was not aware of the participants’ assigned treatment groups. 3 Adhesive Capsulitis (Frozen Shoulder), Idiopathic and Diabetic. Intervention 1: Intervention group: Single intra-articular injection of 4 mL platelet-rich plasma (activated with thrombin, 1:10) mixed with 4 mL of 2% lidocaine and diluted with distilled water to a final volume of 20 mL. The injection was administered into the glenohumeral joint (15 mL) and the subacromial space (5 mL) via posterior approach. Intervention 2: Intervention group: Single intra-articular injection of 1 mL triamcinolone acetonide (40 mg/mL) with 4 mL platelet-rich plasma and 4 mL of 2% lidocaine, diluted with distilled water to a final volume of 20 mL. The injection was administered into the glenohumeral joint (15 mL) and the subacromial space (5 mL) via posterior approach. Intervention 3: Control group: Single intra-articular injection of 2 mL triamcinolone acetonide (40 mg/mL) with 4 mL of 2% lidocaine, diluted with distilled water to a final volume of 20 mL. The injection was administered into the glenohumeral joint (15 mL) and the subacromial space (5 mL) via posterior approach. Yes - There is a plan to make this available What will be shared: An anonymized individual participant dataset, including demographic variables, primary and secondary outcome measures, and other study-related data, along with the data dictionary and statistical analysis codes, will be provided in standard electronic formats (CSV or SPSS). All data will be reviewed and de-identified prior to release." When: Access to the data will be available starting 6 months after publication of the main article in a peer-reviewed journal and will continue for 5 years after the publication date." To whom: Access will be granted to researchers affiliated with universities, recognized research institutions, or healthcare organizations who have an approved research proposal." Conditions: "The data may be used solely for secondary analyses related to the study topic and for the purpose of publishing results in reputable scientific journals. Use of the data requires signing a data use agreement and adherence to ethical and confidentiality considerations." Where to obtain: Requests should be addressed to Dr. Saeed Enayati, Faculty of Medicine, Islamic Azad University, Shahrood Branch. Email: [your email], Tel: +98 23 [phone number]." How to obtain: The requesting researcher must submit a formal application along with their research proposal. The request will be reviewed by the university's scientific/ethical committee, and upon approval, a data use agreement will be signed. Following completion of the process, the data will be delivered securely and in encrypted form within 4 weeks Comments: Data transfer will be carried out electronically through secure platforms only. Any unauthorized use or dissemination without written permission is prohibited."
public Dr. Saeed Enayati
No. 1, North Ferdowsi Street, Faculty of Medicine, Shahrood Branch, Islamic Azad University, Shahrood, Semnan Province, Iran
Shahrood Iran (Islamic Republic of) 43189-36199 +98 23 3239 5001 info@iau-shahrood.ac.ir Islamic Azad University scientific Dr. Saeed Enayati
No. 1, North Ferdowsi Street, Faculty of Medicine, Shahrood Branch, Islamic Azad University, Shahrood, Semnan Province, Iran
Shahrood Iran (Islamic Republic of) 36199-43189 +98 23 3239 5001 edc@iau-shahrood.ac.ir Islamic Azad University Iran (Islamic Republic of) Age between 30 and 75 years; unilateral frozen shoulder diagnosed by physical examination and clinical evaluation; shoulder pain persisting for at least one month; loss of at least one-third of the range of motion in various shoulder movements; normal shoulder joint radiography; normal neurological examination of the proximal upper limb; and no prior pain relief interventions for the affected shoulder. 30 years 78 years Both History of previous treatments aimed at reducing shoulder pain, such as intra-articular injections; unwillingness to continue participation in the study; any intra-articular pathology of the glenohumeral joint or shoulder pain due to other causes; history of trauma or shoulder surgery; clinical evidence of Sudeck’s atrophy syndrome; injection in the affected shoulder joint within the past six months; use of non-steroidal anti-inflammatory drugs in the last seven days; presence of blood disorders or current antiplatelet or anticoagulant treatment; presence of thyroid or lung disorders, particularly emphysema and chronic bronchitis; neoplastic disorders; pregnancy or breastfeeding; uncontrolled diabetes; neurological, rheumatological, malignant, or immunodeficiency diseases; history of drug or alcohol use or addiction; and cervical radiculopathy. M75.0 – Ad Adhesive capsulitis of shoulder Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Single intra-articular injection of 4 mL platelet-rich plasma (activated with thrombin, 1:10) mixed with 4 mL of 2% lidocaine and diluted with distilled water to a final volume of 20 mL. The injection was administered into the glenohumeral joint (15 mL) and the subacromial space (5 mL) via posterior approach. Intervention group: Single intra-articular injection of 1 mL triamcinolone acetonide (40 mg/mL) with 4 mL platelet-rich plasma and 4 mL of 2% lidocaine, diluted with distilled water to a final volume of 20 mL. The injection was administered into the glenohumeral joint (15 mL) and the subacromial space (5 mL) via posterior approach. Control group: Single intra-articular injection of 2 mL triamcinolone acetonide (40 mg/mL) with 4 mL of 2% lidocaine, diluted with distilled water to a final volume of 20 mL. The injection was administered into the glenohumeral joint (15 mL) and the subacromial space (5 mL) via posterior approach. Change in shoulder pain, disability (SPADI, VAS), and range of motion measured at baseline, 4 weeks, and 8 weeks after treatment. Timepoint: Baseline, 4 weeks, and 8 weeks after intervention. Method of measurement: Shoulder Pain and Disability Index questionnaire. Change in pain intensity score measured by the Visual Analogue Scale from baseline to 8 weeks after intervention. Timepoint: Baseline, 4 weeks, and 8 weeks after intervention. Method of measurement: Measured using a goniometer for shoulder range of motion. Islamic Azad University Approved 2025-05-05 Ethics Committee of Islamic Azad University, Shahrood Branch No. [—], University Blvd., Islamic Azad University, Shahrood Branch, Shahrood, Semnan Province, Iran Shahrood Semnan Iran (Islamic Republic of)