NCT05291650已完成4 期
Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad Versus Placebo Injection in Knee Osteoarthritis: a 12-week Double-blinded Controlled Trial
Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the change of effusion-synovitis volume
研究概览
简要总结
This aims of this study is to investigate the efficacy and safety of the glucocorticoid injection into the infrapatellar fat pad among knee osteoarthritis patients with an inflammatory phenotype.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with symptomatic knee osteoarthritis (OA) according to American College of Rheumatology criteria;
- •Age > 45 years;
- •Have knee pain for more than six months and the knee pain over the past week assessed by VAS (100 mm) ≥ 40 mm;
- •Ultrasonography showed obvious synovitis with effusion in the knee joint;
- •Both MRI-assessed Hoffa-synovitis score (MOAKS method) and effusion-synovitis score (modified WORMS method) ≥ 1, and their total score ≥ 3;
- •Being able to listen, speak, read and understand Chinese, capable of understanding the study requirements and cooperating with the researchers during the study, and providing written informed consent.
排除标准
- •Allergy to glucocorticoids;
- •Knee injection of glucocorticoid or hyaluronic acid within the past six months;
- •Severe trauma or arthroscopy in the knee within the past six months;
- •Planned hip or knee surgery (including arthroscopy, arthroplasty, and other open joint surgeries) in the next six months;
- •Contraindication to having magnetic resonance imaging (MRI) (e.g., implanted pacemaker, artificial metal valve or cornea, aneurysm clipping surgery, arterial dissection, metal foreign bodies in the eyeball, claustrophobia);
- •Presence of other arthritis, such as rheumatoid arthritis and psoriatic arthritis;
- •Other physical condition that is more painful than their knee OA;
- •Malignant tumors or other life-threatening diseases;
- •Infection, diabetes, coagulopathy, osteonecrosis, or gastric/duodenal ulcer within the past 12 months;
- •Current use of oral corticosteroids, nonsteroidal anti-inflammatory drugs, or immunosuppressive medication;
- •Pregnancy or lactating female;
- •Use any investigational drugs or devices in the recent 30 days.
研究组 & 干预措施
glucocorticoid injection into infrapatellar fat pad
Active Comparator
干预措施: Glucocorticoids (Drug)
glucocorticoid injection into infrapatellar fat pad
Active Comparator
干预措施: Hyaluronic acid (Drug)
placebo injection into infrapatellar fat pad
Placebo Comparator
干预措施: Saline (Drug)
placebo injection into infrapatellar fat pad
Placebo Comparator
干预措施: Hyaluronic acid (Drug)
结局指标
主要结局
the change of effusion-synovitis volume
时间窗: over 12 weeks (assessed at baseline and the 12th week)
the change of magnetic resonance imaging assessed effusion-synovitis volume
the knee pain change
时间窗: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
the knee pain change measured with visual analogue scale (VAS, 0-100), a higher VAS score means more severe pain
次要结局
- the change in WOMAC score(over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week))
- the change in Hoffa-synovitis score(over 12 weeks (assessed at baseline and the 12th week))
- the change in quality of life(over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week))
- the change in pain medication use(over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week))
- the change in Infrapatellar fat pad volume(over 12 weeks (assessed at baseline and the 12th week))
- adverse reaction(the 4th week, the 8th week, and the 12th week)
研究者
研究点 (1)
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