Frozen Shoulder Clinical Trials

Objectives： This study aims to compare the efficacy of transcatheter arterial microembolization (TAME) and corticosteroid injection for treatment of frozen shoulder. Background： Frozen shoulder (adhesive capsulitis) is a common condition that leads to significant functional impairment and reduced quality of life. Current treatment options are diverse, including pharmacological therapy, physical rehabilitation, corticosteroid injection, hydrodilatation, and the more recently developed transcatheter arterial microembolization (TAME). Corticosteroid injection, due to its anti-inflammatory effects, has been shown in numerous clinical studies to provide short-term pain relief and improved range of motion; however, its benefits are often limited to several weeks or months, and some patients continue to experience persistent symptoms. In contrast, TAME has emerged as a novel treatment for musculoskeletal disorders by targeting abnormal neovascularization and inflammatory processes in the affected tissues, there by achieving pain reduction. Multiple studies from both international and domestic medical centers have demonstrated its safety and efficacy, though most reports focus on case reports or case series observational outcomes. To date, there is a lack of clinical trials directly comparing the therapeutic outcomes of TAME versus corticosteroid injection in patients with frozen shoulder. Study Design： This study is a single-center, prospective, randomized controlled trial (RCT). Methods： A total of 94 patients diagnosed with frozen shoulder in the freeing stage will be recruited from the Department of Physical Medicine and Rehabilitation at Shin Kong Hospital. Eligible patients will be randomly assigned to either the transcatheter arterial microembolization (TAME) group and the corticosteroid injection (CS) group. The arterial microvascular embolization group will receive one treatment, while the corticosteroid injection group will receive two corticosteroid injections into the shoulder joint and subacromial bursa, with a two-week interval between the two injections. Additionally, all patients in both groups will undergo 4 weeks of physical therapy. Clinical assessments will be conducted at baseline and at 1, 2, 4, and 6 months after initiation of treatment, including Shoulder Pain and Disability Index (SPADI), the Visual Analogue Scale (VAS) for pain, Shoulder Disability Questionnaire (SDQ), active and passive range of motion (ROM), Short Form-36 (SF-36) for quality of life, and patient-reported global efficacy. Patients will be followed for 6 months after completion of treatment, and statistical analyses will be performed to evaluate the therapeutic outcomes. Effect： Efficacy comparison: Both the TAME and corticosteroid injection are expected to effectively improve pain, function, and quality of life. However, the TAME group is anticipated to demonstrate greater pain relief and better recovery of shoulder function compared with the corticosteroid injection group, with longer-lasting therapeutic effects. Safety: Both treatments are considered safe. TAME may lead to temporary local pain, transient radial artery spasm, or low-grade fever, all of which are self-limiting or manageable with supportive care. Corticosteroid injection may be associated with transient hyperglycemia, local injection site pain, or, rarely, infection. No permanent or severe adverse events are expected. Exploration of prognostic factors: By comparing treatment responses between the two groups and incorporating clinical characteristics, imaging findings, and treatment outcomes, this study aims to identify potential prognostic factors that may predict therapeutic response, thereby guiding future clinical decision-making. Intermediate follow-up results: At 1 to 3 months post-treatment, both groups are expected to show improvement in the clinical outcomes, but the TAME group is expected to demonstrate superior effect compared with that of the corticosteroid injection group.