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IRCT20250715066507N2 IRCT 2026-08-20 Center of Elites and Top Talents, Law Enforcement Command of the Islamic Republic of Iran (FARAJA) Evaluation of the Efficacy and Safety of Arterial Embolization Using Imipenem/Cilastatin in the Management of Treatment-Resistant Adhesive Capsulitis of the Shoulder: A Single-Arm Pilot Trial Evaluation of the Effectiveness and Safety of Imipenem/Cilastatin Transarterial Embolization for Reducing Pain and Improving Shoulder Function in Patients with Treatment-Resistant Adhesive Capsulitis: A Single-Arm Pilot Clinical Trial 2026-09-03 anticipated 17 Recruiting https://irct.ir/trial/92191 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 0 (exploratory trials) Treatment-resistant adhesive capsulitis of the shoulder. Intervention group: All eligible participants will undergo transarterial embolization using imipenem/cilastatin. The procedure will be performed by an interventional radiologist to embolize the pathological arterial branches supplying the shoulder joint capsule.. Yes - There is a plan to make this available What will be shared: The shared dataset will include de-identified participant data, demographic and clinical characteristics, imaging findings, procedural details of transarterial embolization, and clinical outcomes including pain severity (VAS), shoulder function (Constant–Murley Score), and shoulder range of motion measured at baseline and at 1, 3, and 6 months after the intervention. No personally identifiable information will be shared. When: De-identified data will be available upon reasonable request after publication of the study results for a period of five years. To whom: Qualified researchers, research institutions, and scientific journals may access the de-identified dataset upon reasonable request and approval by the principal investigator. Conditions: The de-identified data may be used for scientific research, educational purposes, systematic reviews, and meta-analyses following approval by the principal investigator. All data must be used in accordance with research ethics and participant confidentiality requirements. Where to obtain: Requests should be directed to the Principal Investigator (Dr. Hamed Ghorani) through Imam Khomeini Hospital Complex. How to obtain: Applicants must submit a written request describing the intended use of the data. The request will be reviewed by the principal investigator for scientific and ethical appropriateness. Upon approval, the de-identified dataset will be shared. Comments:
public Hamed Ghorani
No. 8, 4th Floor, South Abdollah Shokrabi Alley, Naz Alley, Heydari Street, Daneshgar, South Attari Moghaddam, Khaghani Street (Zargandeh), Shariati Street, Tehran, Iran.
tehran Iran (Islamic Republic of) 1419733141 +98 21 8490 1000 hamedqurani@gmail.com Tehran University of Medical Sciences scientific Hamed Ghorani
No. 8, 4th Floor, South Abdollah Shokrabi Alley, Naz Alley, Heydari Street, Daneshgar, South Attari Moghaddam, Khaghani Street (Zargandeh), Shariati Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 8490 1000 hamedqurani@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 75 Clinical diagnosis of adhesive capsulitis with limitation of both active and passive shoulder range of motion, particularly external rotation. Failure to respond to at least 3 months of standard conservative treatment, including structured physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), and a maximum of one intra-articular corticosteroid injection.Less than 30% improvement in pain severity (VAS) or less than 20° improvement in shoulder flexion or abduction range of motion compared with baseline Imaging performed to exclude other shoulder pathologies, such as full-thickness rotator cuff tear, advanced osteoarthritis, or avascular necrosis. 18 years 75 years Both Active infection. Uncorrectable coagulation disorder Severe allergy to contrast media or beta-lactam antibiotics. Pregnancy or breastfeeding. Severe vascular disease precluding safe catheterization. Presence of other shoulder disorders, including fracture, inflammatory arthritis, or malignancy Inability to provide informed consent or comply with follow-up. M75.0 Adhesive capsulitis of shoulder Treatment - Surgery Intervention group: All eligible participants will undergo transarterial embolization using imipenem/cilastatin. The procedure will be performed by an interventional radiologist to embolize the pathological arterial branches supplying the shoulder joint capsule. Shoulder pain severity. Timepoint: Baseline (pre-intervention), 1 month, 3 months, and 6 months post-intervention. Method of measurement: Pain severity will be assessed using the Visual Analog Scale (VAS). Shoulder function. Timepoint: Baseline (pre-intervention), 1 month, 3 months, and 6 months post-intervention. Method of measurement: Shoulder function will be assessed using the Constant–Murley Score (CMS). Shoulder range of motion (ROM). Timepoint: Baseline (pre-intervention), 1 month, 3 months, and 6 months post-intervention. Method of measurement: Shoulder range of motion (flexion, abduction, and external rotation) will be measured using a goniometer. Center of Elites and Top Talents, Law Enforcement Command of the Islamic Republic of Iran (FARAJA) Approved 2026-08-02 Research Ethics Committee of the Center of Elites and Talents of the Armed Forces No. 182, Shahid Beheshti School of Governance, corner of Shohada Street, Ghaem Magham Farahani Street, Shahid Beheshti Street, Tehran 1586755414, Iran. Tehran Tehran Iran (Islamic Republic of)