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Completed
NCT07731646
Local Anesthesia While Awake Versus General Anesthesia for Frozen Shoulder Manipulation
Conditions: Frozen Shoulder, Adhesive Capsulitis of the Shoulder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 72
Sponsor: Izmir Katip Celebi University
Location: Izmir Katip Celebi University Ataturk Training and Research Hospital Izmir İzmir
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.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older.
* Diagnosis of primary frozen shoulder.
* Persistent symptoms despite at least 6 months of conservative treatment.
* Frozen shoulder defined by at least one of the following: forward flexion less than 100 degrees, external rotation less than 60 degrees, internal rotation limited such that the dorsum of the hand could not reach above the L5 vertebral level, or at least a 50% reduction in shoulder motion in any plane compared with the unaffected shoulder.
* Willingness to provide written informed consent and comply with the study procedures and follow-up schedule.
Exclusion Criteria:
* Secondary frozen shoulder.
* Known allergy to any medication planned for use in the study.
* Pregnancy or breastfeeding.
* Severe osteoporosis.
* Unstable systemic medical condition.
* Active infection at the planned intervention site.
* Hemiplegia or hemiparesis affecting the involved extremity.
Source: ClinicalTrials.gov (NCT07731646). StuddyBuddy aggregates publicly available trial information.