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.
1). age between 18 to 80 years old;
2). shoulder pain for ≥ 1 month;
3). > 30% loss of passive range of motion (ROM) of the affected shoulder in external rotation and/or abduction, comparing with the sound side;
4). pain VAS on maximal passive external rotation or abduction > 4;
1). severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
2). uncontrolled DM;
3). rotator cuff tear or calcification of the affected shoulder;
4). fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders; - 5). a history of allergy to local anesthetics, corticosteroids, imipenem/cilastatin sodium or contrast medium;
Parallel
TAME group
Other interventionParticipants allocated to the TAME group will undergo transarterial microvascular embolization following a standardized protocol. All procedures will be performed under local anesthesia. Percutaneous access to the ipsilateral radial artery will be established using a 4-F introducer sheath. Subsequently, subclavian digital subtraction angiography will be carried out using a 4-F diagnostic catheter. A total of 15 mL of iodinated contrast medium will be administered at an injection rate of 3 mL/s. Angiography will be performed via slow manual injection of 1-2 mL of contrast material. When abnormal vascular staining is identified or when the patient reports evoked pain-defined as reproducible shoulder pain or a heat-like sensation that matches their typical symptoms-embolization will be initiated. The embolization endpoint is defined as the elimination or substantial reduction of abnormal vascularity.
CS injection group
Other interventionThe participants will receive corticosteroid (20mg triamcinolone with 3mL 1% lidocaine in a 5 mL syringe) posterior GHJ and SASD bursa injection for 2 times at 2 weekly interval. Physical therapy: The physical therapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, strengthening and mobilization exercise), three times a week, and will be continued for 4 weeks.
Shoulder Pain and Disability Index (SPADI)
The SPADI is a self-administered questionnaire that evaluates the pain and disability of shoulder diseases. It has 2 subclasses (pain and disability) that consist of 13 items. The pain domain has 5 items and the disabilities domain has 8 items. The SPADI score, which ranges between 0 (best score) and 100 (worst score), is calculated by averaging the scores from the 2 subclasses.18 The minimal clinically important difference (MCID) for SPADI is 14.1-20.6.
visual analog scale (VAS)
The pain VAS is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain. The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of pain VAS is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated. The MCID of pain VAS for shoulder disorder is 1.37.
Shoulder Disability Questionnaire (SDQ)
The SDQ is a pain-related questionnaire that contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The response options are "yes," "no," and "not applicable." The final score is calculated by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst possible condition).
Range of motion (ROM)
All the 4 planes of ROM will be measured. It includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0° of abduction. The measure tool is a conventional goniometer, and the examiner is the trained research assistant to ensure the measurements consistent.
36-item Short Form Health Survey (SF-36)
Quality of life: General health status will be measured with the SF-36. The SF-36 is a generic measure of quality of life and is composed of 8 subscales related to the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score from 0 to 100, and higher scores indicate better health. We will use a Chinese-language version of the SF-36 for which the psychometric properties have been established.
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