Hand Ultrasonography: Clinical and Functional Correlation in Symptomatic Osteoarthritis (OA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline - Correlation between VASr(Visual Analogic Scale of pain at rest 0-10cm) and ultrasonography findings(Grey Scale and power Doppler) at 1year in six times
研究概览
简要总结
Objective: To evaluate the correlation / association between inflammatory ultrasonography findings and clinical /functional assessment in symptomatic hand OA interphalangeal joints (IP). To evaluate the intra and interobserver reproducibility of ultrasound findings.
Methods: It was conducted a prospective study in 60 symptomatic hand OA patients. They were assessed in six times (T0, T1, T4, T8, T12 and T48 weeks) by "blind" observers (clinical and ultrasonography). The intra and interobserver reproducibility analysis was performed in 25% of the sample. Differences were considered as statistically significant when p< 0.05.
详细描述
Introduction Osteoarthritis (OA) is the most prevalent joint disease actually , hand OA is one of the characteristic subtypes. The estimated prevalence is 26% in over 70 years women. Treatment and follow-up of this disease have received less attention when compared to cases involving the knee and hip, probably because such involvement does not present with functional limitations as those seen in large joints.
For diagnosis and follow-up of hand OA the conventional radiography is used, although this exam give us an insight into just two planes of articulation and does not allow a reliable approach of tendons, muscles and other periarticular structures.
The ultrasound (US) appears as an emerging technique. More sensitive techniques are required for disease progression evaluation). It is a very useful imaging method, capable of showing early and late inflammation-related injuries and structural damage and is considered a great test to follow-up rheumatic diseases patients. Safe, easy to perform, low cost, fast and able to evaluate various sites attacked in the same turn, can be used in monitoring and evaluation of therapeutic response in these patients.
Some authors suggest that the sonographic evaluation is better than that of plain radiography, does not involve radiation and allows the joint evaluation at various sites. However, ultrasound still has limited use in hand OA compared to this use in inflammatory joint diseases.
The objectives of this study were to evaluate the correlation / association between ultrasonographic findings of inflammatory synovial hypertrophy and power Doppler of the interphalangeal joints(IP) and clinical and functional variables in patients with hand OA and test the intra and interobserver reproducibility of these ultrasonographic findings
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hand OA, according to the criteria of the American College of Rheumatology (ACR) (Altman et al., 1990) with involvement of proximal and / or distal IP joints
- •More than 40 years old
- •Visual analog scale of pain (VAS of 0-10 cm) in the joint of study between 3-8cm
- •And agree and sign the Consent Term of the study.
排除标准
- •Changed the use of oral corticosteroids and nonsteroidal anti-inflammatory drugs in the last thirty days
- •Changed the treatment of OA in the last two months (including drug and rehabilitation)
- •Radiography of hands suggesting interphalangeal arthropathy of other etiology (psoriatic arthritis, microcrystalline arthropathy).
结局指标
主要结局
Change from baseline - Correlation between VASr(Visual Analogic Scale of pain at rest 0-10cm) and ultrasonography findings(Grey Scale and power Doppler) at 1year in six times
时间窗: 0,1,4,8,12 and 48 weeks
次要结局
- Change from baseline - Correlation between use of analgesics(tablets per day of paracetamol) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times(0,1,4,8,12 and 48 weeks)
- Change from baseline - Correlation between handgrip strength determined by Jamar dynamometer grip(kgf) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times(0,1,4,8,12 and 48 weeks)
- Change from baseline - Correlation between joint goniometry(°) and ultrasonography findings ( determined using the Grey Scale and power Doppler in affected joint) at 1year in six times(0,1,4,8,12 and 48 weeks)
- Change from baseline - Correlation between VASs(Visual Analogic Scale of joint swelling 0-10cm) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint)) at 1year in six times(0,1,4,8,12 and 48 weeks)
- Change from baseline - Correlation between pinch strength determined by the dynamometer of Pinch Gauge(kgf) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times(0,1,4,8,12 and 48 weeks)
- Change from baseline - Correlation between VAS of the joint on movement and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times(0,1,4,8,12 and 48 weeks)
- Change from baseline - Correlation between hand function(determined by AUSCANindex and COCHIN questionnaire) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times(0,1,4,8,12 and 48 weeks)
研究者
Natalia de Oliva Spolidoro Paschoal
Dr
Federal University of São Paulo