Clinical Trial

Local Anesthesia While Awake Versus General Anesthesia for Frozen Shoulder Manipulation

Completed
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Summary
This study compared two anesthesia approaches for shoulder manipulation in adults with primary frozen shoulder that had not improved after at least 6 months of conservative treatment. A total of 72 participants were randomly assigned to undergo manipulation either with ultrasound-guided wide-awake local anesthesia no tourniquet (WALANT) in an outpatient setting or under general anesthesia in the operating room. The main outcome was shoulder forward flexion 4 weeks after the procedure. Other outcomes included shoulder abduction, external rotation, internal rotation, pain, shoulder function, anxiety before the procedure, and early procedure-related complications. Participants were evaluated before the procedure and during the first 4 weeks after treatment. The study aimed to determine whether outpatient manipulation under WALANT could provide short-term clinical outcomes comparable to those of manipulation under general anesthesia.
Trial Details
NCT Number NCT07731646
Lead Sponsor Izmir Katip Celebi University
Conditions Frozen Shoulder, Adhesive Capsulitis of the Shoulder
Enrollment 72 participants
Start Date 2025-02-24
Primary Completion 2025-08-25 (estimated)
Study Completion 2025-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-29