Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- VAS for pain
研究概览
简要总结
Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter major, overlying the lateral aspect of the hip. When pain is persistent after conventional therapies, anesthetic and corticosteroid (CS) injections can provide short term to intermediate relief of pain, but relapse is common. Only one retrospective study showed the efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the pain release is significant with large effect sizes for both treatment. However, the efficacy of CS appeared to be short lived and it was shown that the efficacy of HA at 6 and 12 months is significant compared to CS (p<0.05).
In this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the treatment of trochanteric bursitis.
详细描述
See brief summary
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years and older, but <75 years;
- •VAS for pain > 30mm;
- •Diagnosis of trochanteric bursitis as suggested by Brinks et al with symptoms for more than 3 months (3);
- •Failure of conservative therapy of more than one month;
- •Written informed consent;
- •Available for the duration of the investigation.
排除标准
- •Previous surgery in the same region;
- •Current other problem(s) in the affected extremity;
- •Diabetes mellitus;
- •Patient who received a local (CS) injection within 3 months from the baseline visit;
- •Allergic or hypersensitive to CS or HA;
- •Patients suffering (chronic) low back pain with or without sciatic pain;
- •Patients with radiographic signs of moderate or severe hip osteoarthritis (Kellgren and Lawrence >1);
- •Pregnant or lactating, or woman of childbearing potential not willing to use an acceptable method of contraception during the study.
研究组 & 干预措施
Hyaluronic acid
Injectable hyaluronic acid.
干预措施: Hyaluronic acid (Device)
Corticosteroids
Injectable corticosteroids.
干预措施: Corticosteroids (Drug)
结局指标
主要结局
VAS for pain
时间窗: 26 weeks after administration
次要结局
- VAS for pain(6 and 12 weeks after administration)
- Harris Hip Score(6, 12, 26 weeks)
研究者
Dr. Sascha Colen
MD
Universitaire Ziekenhuizen KU Leuven