Tokyo, Jan. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060264) titled 'Study on the Effects of Extracorporeal Shock Wave Therapy for Frozen Shoulder and Prognostic Evaluation Based on Vascularity Assessment' on Jan. 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Keyaki Clinic

Condition: Condition - Frozen shoulder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the relationship between vascularity assessed by power Doppler ultrasonography and both the immediate and medium-to-long-term effects of extracorporeal shock wave therapy in patients with frozen shoulder. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention group: Standard care plus extracorporeal shock wave therapy (ESWT) Interventions/Control_2 - Control group: Standard care alone

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - 1. Patients with unilateral frozen shoulder aged over 40 years 2. Patients who have undergone medical history review, physical examination, X-ray examination, and ultrasound examination 3. Patients presenting with pain and restricted shoulder joint range of motion (Flexion < 140 degree, External rotation < 30 degree, Internal rotation < L1 level) 4. Patients showing no abnormal findings in the shoulder joint on X-ray and ultrasound examinations Key exclusion criteria - 1. Presence of rotator cuff tears or calcification 2. Bilateral shoulder involvement 3. Previous surgical interventions in the neck or shoulder region 4. History of fractures or injuries around the shoulder joint 5. Presence of neurological dysfunction Target Size - 40

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 01 Month 05 Day Date of IRB - 2024 Year 05 Month 16 Day Anticipated trial start date - 2026 Year 01 Month 05 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067433

Disclaimer: Curated by HT Syndication.