Comparison of the Efficacy of Ultrasound-guided Suprascapular Nerve Pulsed Radiofrequency Neuromodulation and Intra-articular Steroid Injection in Frozen Shoulder Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of The Visual Analogue Scale (VAS)
研究概览
简要总结
The aim of this clinical study is to compare the effectiveness of suprascapular nerve pulsed radiofrequency and intra-articular steroid injection in patients with frozen shoulder (adhesive capsulitis). The main questions it aims to answer are:
- What is the effectiveness of intra-articular steroid injection in frozen shoulder?
- What is the effectiveness of suprascapular nerve radiofrequency in frozen shoulder?
- Should these two methods be used together in frozen shoulder?
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral side involvement.
- •≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side.
- •duration of symptoms ≥3 months.
- •age≥ 20year old.
- •Patients with VAS ≥4 before the procedure
排除标准
- •ever received manipulation of the affected shoulder with/without anesthesia. systemic disease, severe degeneration, or trauma involving the shoulder. (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.)
- •neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder.
- •pain or disorders of the cervical spine, elbow, wrist, or hand.
- •a history of drug allergy to local or corticosteroids.
- •Pregnancy or lactation.
- •Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks.
- •Patients with VAS <4 before the procedure
研究组 & 干预措施
suprascapular nerve radiofrequency group (SCNRFT)
SCNRFT+intra-articular steroid and local anesthesic injection with physiotherapy. Suprascapular nerve RFT: Ultrasound-guided SCNRFT 42ºC, 360ms.
Ultrasound-guided intraarticular injection with 40mg triamcinolone+3 cc %0.5 bupivacaine.
Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening)
干预措施: suprascapular nerve radiofrequency group (SCNRFT) (Procedure)
intra-articular corticosteroid injection (IACI) group
IACI with physiotherapy. Intra-articular steroid+local anesthesic injection: Receive intra-articular corticosteroid injection. Ultrasound-guided IACI with 3c.c. 0.5% bupivacaine and 40mg triamcinolone.
Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening)
干预措施: intra-articular corticosteroid injection (IACI) group (Other)
结局指标
主要结局
Change of The Visual Analogue Scale (VAS)
时间窗: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
次要结局
- The active ROM(Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.)
- Change of scores of the Shoulder Pain and Disability Index (SPADI)(Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.)
研究者
Dostalı Alıyev
Principal Investigator
Ankara University