Adhesive Capsulitis of the Shoulder, Frozen Shoulder
Conditions
Keywords
Adhesive capsulitis, frozen shoulder, manipulation, WALANT, general anesthesia, outpatient procedure, shoulder range of motion
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.
Detailed description
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.
Interventions
PROCEDUREUltrasound-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.
PROCEDUREShoulder Manipulation Under General Anesthesia
Standardized shoulder manipulation performed in the operating room under general anesthesia induced with intravenous propofol.
Sponsors
Izmir Katip Celebi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
randomized controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Shoulder Forward Flexion at 4 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Shoulder Abduction | 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. |
| Mean Shoulder External Rotation | 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. |
| Distribution of Shoulder Internal Rotation Categories | 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. |
| Mean Visual Analog Scale Pain Score | 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. |
| Mean Modified UCLA Shoulder Score | 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. |
| Mean DASH Score | 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. |
| Mean Constant-Murley Score | 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. |
| Mean Preprocedural STAI-6 Score | 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. |
| Number of Participants With Early Procedure-Related Complications | 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. |
| Mean Shoulder Forward Flexion at Early Follow-up Time Points | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed