Local Anesthesia While Awake Versus General Anesthesia for Frozen Shoulder Manipulation | NCT07731646

NCT07731646

Overview

NCT ID: NCT07731646
Lead Sponsor: Izmir Katip Celebi UniversityOTHER
Official Title: WALANT Technique Versus General Anesthesia in Frozen Shoulder Manipulation: A Prospective Randomized Controlled Trial
Brief 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.

Status and Timeline

Status: Completed
Last Update Posted: Jul 29, 2026Actual
Start Date: Feb 24, 2025Actual
Primary Completion Date: Aug 25, 2025Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 72Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Izmir Katip Celebi University Ataturk Training and Research Hospital

Similar Studies

Participant Group/Arms

Ultrasound-Guided WALANT-Based ManipulationExperimental

Participants received ultrasound-guided administration of a 25-mL WALANT solution containing 12 mL of 2% lidocaine, 0.5 mL of 1:1,000 epinephrine, 2.5 mL of 8.4% sodium bicarbonate, and 10 mL of 0.9% sodium chloride into the glenohumeral joint, anterior capsule, and coracohumeral ligament region. After a 30-minute waiting period, standardized shoulder manipulation was performed in an outpatient setting.

Procedure: Ultrasound-Guided WALANT-Based Shoulder Manipulation

Manipulation Under General AnesthesiaActive Comparator

Participants underwent standard preoperative preparation and shoulder manipulation in the operating room. General anesthesia was induced with intravenous propofol with mask ventilation provided throughout the procedure. The same standardized shoulder manipulation sequence was used as in the WALANT group.

Procedure: Shoulder Manipulation Under General Anesthesia