WALANT Technique Versus General Anesthesia in Frozen Shoulder Manipulation: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Mean Shoulder Forward Flexion at 4 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ultrasound-Guided WALANT-Based Manipulation
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.
干预措施: Ultrasound-Guided WALANT-Based Shoulder Manipulation (Procedure)
Manipulation Under General Anesthesia
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.
干预措施: Shoulder Manipulation Under General Anesthesia (Procedure)
结局指标
主要结局
Mean Shoulder Forward Flexion at 4 Weeks
时间窗: 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.
次要结局
- 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)
- Mean DASH Score(Baseline and 1, 2, 3, and 4 weeks after the procedure)
- Mean Constant-Murley Score(Baseline and 1, 2, 3, and 4 weeks after the procedure)
- Mean Preprocedural STAI-6 Score(Immediately before the procedure)
- Number of Participants With Early Procedure-Related Complications(From the procedure through 4 weeks after the procedure)
- Mean Shoulder Forward Flexion at Early Follow-up Time Points(Baseline and 1, 2, and 3 weeks after the procedure)
研究者
Tolgacan Kurtulus
Principal Investigator
Izmir Katip Celebi University