Comparison of Anterior, Posterior, and Combined Intra-Articular Injection Techniques in Patients With Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Change in Shoulder Range of Motion (ROM)
研究概览
简要总结
This randomized controlled clinical trial aims to compare the efficacy of three different intra-articular injection approaches (anterior, posterior, and combined anterior-posterior) in patients with adhesive capsulitis of the shoulder. Thirty participants will be randomly assigned to one of three groups and treated with a standardized injection solution consisting of corticosteroid, lidocaine, and saline. Clinical outcomes will be evaluated using pain scores, functional scales, and imaging parameters.
详细描述
Adhesive capsulitis (frozen shoulder) is a disabling condition characterized by progressive pain and stiffness of the glenohumeral joint. Intra-articular corticosteroid injections are frequently used to reduce pain and improve mobility; however, the optimal injection approach remains controversial.
This single-center randomized controlled trial will investigate three different approaches: posterior, anterior, and combined anterior-posterior injections. The primary endpoint is improvement in active and passive range of motion. Secondary endpoints include pain scores (VAS), functional outcome measures (SPADI, qDASH, ASES, Constant-Murley, Scratch Test, Subjective Shoulder Value), and ultrasound evaluation of axillary capsule thickness. Assessments will be performed at baseline, immediately after injection, and at weeks 3, 6, and 12.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years Unilateral shoulder pain and stiffness (symptom duration 1-9 months) NRS pain score ≥ 7/10 Passive range of motion limitation >50% in at least two planes, or >30° restriction in ≥2 planes "Freezing stage" (stage 2 adhesive capsulitis) No analgesic use (NSAIDs, opioids, acetaminophen) within 12 hours before intervention Radiography and/or MRI excluding other pathologies (rotator cuff tear, labral lesion, osteoarthritis, etc.)
排除标准
- •Secondary adhesive capsulitis (trauma, surgery, systemic disease) Prior shoulder surgery or intra-articular steroid injection within 3 months Bilateral frozen shoulder Neurological disorders (Parkinson's disease, ALS, neuropathies) Malignancy, infection, cellulitis, septic arthritis, acute fracture Cognitive impairment, psychiatric disorders, pregnancy Steroid or local anesthetic allergy Poor glycemic control or other contraindications to steroid injections
研究组 & 干预措施
Arm A: Posterior Injection
Single intra-articular injection with corticosteroid + lidocaine + saline via the posterior glenohumeral approach.
干预措施: Intervention Name: Posterior Intra-articular Injection (Drug)
Arm B - Anterior Injection
Same injection solution administered via the anterior (rotator interval) approach.
干预措施: Anterior Intra-articular Injection (Drug)
Arm C - Combined Anterior + Posterior Injection
Same injection solution administered using both anterior and posterior approaches.
干预措施: Combined Anterior + Posterior Intra-articular Injection (Drug)
结局指标
主要结局
Change in Shoulder Range of Motion (ROM)
时间窗: Baseline, immediately post-injection, week 3, week 6, week 12
Change in active and passive shoulder joint range of motion (flexion, extension, abduction, external rotation, internal rotation) measured with a goniometer.
次要结局
- Change in Pain Intensity (NRS)(Baseline, immediately post-injection, week 3, week 6, week 12)
- Subjective Shoulder Value (SSV)(Baseline, immediately post-injection, week 3, week 6, week 12)
- Shoulder Pain and Disability Index (SPADI)(Baseline, week 3, week 6, week 12)
- Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)(Baseline, week 3, week 6, week 12)
- American Shoulder and Elbow Surgeons (ASES) Score(Baseline, week 3, week 6, week 12)
- Constant-Murley Shoulder Score(Baseline, week 3, week 6, week 12)
- Scratch Test Score(Baseline, immediately post-injection, week 3, week 6, week 12)
- Axillary Capsule Thickness (Ultrasound)(Baseline, immediately post-injection (only).)
研究者
Aslinur Keles Ercisli, MD, PhD
Principal investigator
Fatih Sultan Mehmet Training and Research Hospital