The Efficacy of Ultrasonication in Combination With Corticosteroid Intraarticular Injection for Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Reduction in Synovial Swelling Area Assessed by Joint Ultrasound
研究概览
简要总结
This study investigates whether ultrasound therapy applied prior to intra-articular corticosteroid injection can enhance the treatment efficacy for patients with joint arthritis and assess its safety. Adult patients diagnosed with arthritis in the limbs who are indicated for corticosteroid injection are eligible, while patients with joint replacement, hip joint involvement, gout, infectious arthritis, or local cellulitis are excluded.
Ultrasound therapy is a valuable physical therapy tool for musculoskeletal diseases, producing therapeutic effects through thermal and non-thermal mechanisms. It can improve tissue extensibility, reduce joint stiffness, increase local blood flow, enhance metabolism during tissue repair, and facilitate drug absorption. This study evaluates whether applying ultrasound before intra-articular corticosteroid injection improves therapeutic outcomes in patients with arthritis, and assesses the safety of this combined intervention. Patients aged 18 or older, diagnosed with limb arthritis, and indicated for corticosteroid injection are eligible. Exclusion criteria include joint replacement, hip joint involvement, gout, infectious arthritis, or local cellulitis at the treatment site.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Diagnosed with arthritis in the limbs.
- •Inadequate response to or contraindication for oral anti-inflammatory medications.
- •Assessed by a physician as requiring intra-articular corticosteroid injection.
排除标准
- •History of joint replacement (prosthetic joint) in the affected area.
- •Hip joint involvement.
- •Diagnosis of gout.
- •Infectious arthritis.
- •Presence of cellulitis at the treatment site.
研究组 & 干预措施
corticosteroid intraarticular injection
干预措施: Intra-articular corticosteroid injection (Procedure)
ultrasonication in combination with corticosteroid intraarticular injection
干预措施: Therapeutic Ultrasound (Device)
ultrasonication in combination with corticosteroid intraarticular injection
干预措施: Intra-articular corticosteroid injection (Procedure)
结局指标
主要结局
Reduction in Synovial Swelling Area Assessed by Joint Ultrasound
时间窗: From enrollment to the end of treatment at 2 weeks
Synovial swelling area (pixels) assessed by joint ultrasound. A treatment response is defined as a ≥50% reduction in synovial swelling area from baseline.
Change in Power Doppler (PD) Score of the Target Joint
时间窗: From enrollment to the end of treatment at 2 weeks
Power Doppler (PD) score (range 0-3) of the target joint assessed by joint ultrasound. A treatment response is defined as a PD score of 0 at 2 weeks post-treatment.
Change in Pain Visual Analogue Scale (VAS)
时间窗: From enrollment to the end of treatment at 2 weeks
Pain intensity assessed using a visual analogue scale (VAS 0-10). A treatment response is defined as a ≥50% reduction in VAS score from baseline or a VAS score ≤1 at 2 weeks post-treatment.
次要结局
- Absence of Synovitis Recurrence Based on Power Doppler (PD) Score(From enrollment to 3 months post-treatment)
- Absence of Synovial Swelling Recurrence on Gray-Scale Ultrasound(From enrollment to 3 months post-treatment)
研究者
Kuo-Lung Lai
Principal Investigator
Taichung Veterans General Hospital