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Local Anesthesia While Awake Versus General Anesthesia for Frozen Shoulder Manipulation

NCT07731646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-07-29

No results posted yet for this study

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.

Conditions

  • Frozen Shoulder
  • Adhesive Capsulitis of the Shoulder

Interventions

PROCEDURE

Ultrasound-Guided WALANT-Based Shoulder Manipulation

Ultrasound-guided administration of a 25-mL WALANT solution followed by standardized shoulder manipulation after a 30-minute waiting period in an outpatient setting.

PROCEDURE

Shoulder Manipulation Under General Anesthesia

Standardized shoulder manipulation performed in the operating room under general anesthesia induced with intravenous propofol.

Sponsors & Collaborators

  • Izmir Katip Celebi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2025-08-25
Completion
2025-09-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731646 on ClinicalTrials.gov