Anterior vs Posterior vs Combined Intra-Articular Injections for Adhesive Capsulitis

Официальное название

Comparison of Anterior, Posterior, and Combined Intra-Articular Injection Techniques in Patients With Adhesive Capsulitis

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Intervention Name: Posterior Intra-articular Injection
  A single intra-articular injection consisting of 1 cc corticosteroid, 4 cc 2% lidocaine, and 5 cc saline (total 10 cc) administered via the posterior glenohumeral approach.
• Препарат Anterior Intra-articular Injection
  A single intra-articular injection consisting of 1 cc corticosteroid, 4 cc 2% lidocaine, and 5 cc saline (total 10 cc) administered via the anterior (rotator interval) approach.
• Препарат Combined Anterior + Posterior Intra-articular Injection
  A single intra-articular injection consisting of 1 cc corticosteroid, 4 cc 2% lidocaine, and 5 cc saline (total 10 cc) administered using both anterior and posterior approaches during the same procedure.

Первичные конечные точки

• Change in Shoulder Range of Motion (ROM) [Срок оценки: Baseline, immediately post-injection, week 3, week 6, week 12]

Вторичные конечные точки (8)

• Change in Pain Intensity (NRS) [Срок оценки: Baseline, immediately post-injection, week 3, week 6, week 12]
• Subjective Shoulder Value (SSV) [Срок оценки: Baseline, immediately post-injection, week 3, week 6, week 12]
• Shoulder Pain and Disability Index (SPADI) [Срок оценки: Baseline, week 3, week 6, week 12]
• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) [Срок оценки: Baseline, week 3, week 6, week 12]
• American Shoulder and Elbow Surgeons (ASES) Score [Срок оценки: Baseline, week 3, week 6, week 12]
• Constant-Murley Shoulder Score [Срок оценки: Baseline, week 3, week 6, week 12]
• Scratch Test Score [Срок оценки: Baseline, immediately post-injection, week 3, week 6, week 12]
• Axillary Capsule Thickness (Ultrasound) [Срок оценки: Baseline, immediately post-injection (only).]

Критерии участия

Inclusion Criteria 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.) Exclusion Criteria 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07364227 · ADC2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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