Izmir Katip Celebi University Ataturk Training and Research Hospital
Izmir, İzmir, 35360, Turkey (Türkiye)
NCT Number: NCT07731646
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Izmir, İzmir, 35360, Turkey (Türkiye)
This was a single-center, prospective, randomized, parallel-group controlled trial comparing an ultrasound-guided wide-awake local anesthesia no tourniquet (WALANT)-based outpatient protocol with manipulation under general anesthesia in adults with primary frozen shoulder. Participants had persistent symptoms despite at least 6 months of conservative treatment.
A total of 72 participants were randomly assigned in a 1:1 ratio using a computer-generated randomization sequence. Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes. In the WALANT group, a 25-mL 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 was administered under ultrasound guidance into the glenohumeral joint, anterior capsule, and coracohumeral ligament region in an outpatient setting. After a 30-minute waiting period, shoulder manipulation was performed.
Participants in the general anesthesia group underwent manipulation in the operating room after general anesthesia was induced with intravenous propofol. The same orthopaedic surgeon performed the manipulation procedure in both groups using a standardized sequence of forward flexion, extension, abduction, adduction, internal rotation, and external rotation. Both groups received the same postprocedural analgesia and standardized rehabilitation program. No intra-articular corticosteroid or additional injection therapy was administered.
The primary outcome was shoulder forward flexion at 4 weeks after the procedure. Secondary outcomes included shoulder abduction, external rotation, internal rotation, pain intensity, shoulder function, preprocedural anxiety, and early procedure-related complications. Clinical assessments were performed before the procedure and during the first 4 weeks after treatment by an independent orthopaedic surgeon who was blinded to group allocation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided administration of a 25-mL WALANT solution followed by standardized shoulder manipulation after a 30-minute waiting period in an outpatient setting.
Standardized shoulder manipulation performed in the operating room under general anesthesia induced with intravenous propofol.
Time frame: 4 weeks after the procedure
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.
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Shoulder abduction was measured in degrees using a goniometer. Higher values indicate greater range of motion.
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Shoulder external rotation was measured in degrees using a goniometer. Higher values indicate greater range of motion.
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Internal rotation was categorized according to the highest anatomical level reached by the dorsum of the hand: 1, lateral hip; 2, sacrum; 3, lumbar region; and 4, thoracic region. Higher categories indicate better internal rotation.
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Pain was evaluated on a 0-to-10 Visual Analog Scale, with higher scores indicating greater pain intensity.
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Shoulder function was evaluated using the Modified University of California, Los Angeles Shoulder Score. Scores range from 0 to 35, with higher scores indicating better shoulder function.
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Upper-extremity disability was evaluated using the Disabilities of the Arm, Shoulder and Hand questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Shoulder function was evaluated using the Constant-Murley Score. Scores range from 0 to 100, with higher scores indicating better shoulder function.
Time frame: Immediately before the procedure
Anxiety was evaluated using the six-item short form of the State-Trait Anxiety Inventory-State subscale. Raw scores range from 6 to 24, with higher scores indicating greater anxiety.
Time frame: From the procedure through 4 weeks after the procedure
The number of participants who experienced procedure-related complications, infections, early recurrence, or need for reintervention was recorded.
Time frame: Baseline and 1, 2, and 3 weeks after the procedure
Shoulder forward flexion was measured in degrees using a goniometer. Higher values indicate greater shoulder range of motion.
Izmir Katip Celebi University
Other
WALANT Technique Versus General Anesthesia in Frozen Shoulder Manipulation: A Prospective Randomized Controlled Trial
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