Local Anesthesia While Awake Versus General Anesthesia for Frozen Shoulder Manipulation

NCT07731646 | Completed

• 1 other identifier: IKCU-WALANT-2025-21
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Frozen Shoulder; Adhesive Capsulitis of the Shoulder

Keywords

Adhesive capsulitis; frozen shoulder; manipulation; WALANT; general anesthesia; outpatient procedure; shoulder range of motion

Outcome Measures

Primary Outcomes (1)

• Mean Shoulder Forward Flexion at 4 Weeks

  Shoulder forward flexion was measured in degrees using a goniometer. Higher values indicate greater shoulder range of motion. The mean forward flexion value was compared between the two study arms.

  4 weeks after the procedure

Secondary Outcomes (10)

• Mean Shoulder Abduction

  Baseline and 1, 2, 3, and 4 weeks after the procedure

• Mean Shoulder External Rotation

  Baseline and 1, 2, 3, and 4 weeks after the procedure

• Distribution of Shoulder Internal Rotation Categories

  Baseline and 1, 2, 3, and 4 weeks after the procedure

• Mean Visual Analog Scale Pain Score

  Baseline and 1, 2, 3, and 4 weeks after the procedure

• Mean Modified UCLA Shoulder Score

  Baseline and 1, 2, 3, and 4 weeks after the procedure

Study Arms (2)

Ultrasound-Guided WALANT-Based Manipulation

EXPERIMENTAL

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 Anesthesia

ACTIVE 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

Interventions

Ultrasound-Guided WALANT-Based Shoulder Manipulation PROCEDURE

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

Ultrasound-Guided WALANT-Based Manipulation

Shoulder Manipulation Under General Anesthesia PROCEDURE

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

Manipulation Under General Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University Ataturk Training and Research Hospital

Izmir, İzmir, 35360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: February 24, 2025
• Primary Completion: August 25, 2025
• Study Completion: September 15, 2025
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Data will be available from the corresponding author upon reasonable request. Requests will be evaluated based on the scientific merit of the proposed research and compliance with applicable ethical and patient privacy requirements. Data will be shared only after appropriate institutional approval and completion of a data-use agreement, where required.

Locations

TU (1)