Effectiveness of Triamcinolone Hexacetonide Intra-articular Injection in Interphalangeal Joints: a 12 Weeks Randomized Controlled Trial in Osteoarthritis Hand Patients
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
- Change from baseline in Pain Score on the Visual Analogue Scale (VAS) at 3 months
研究概览
简要总结
Objective - to evaluate the effectiveness and tolerance of intra-articular injections (IAI) of hexacetonide triamcinolone (HT) for the treatment of osteoarthritis (OA) in interphalangeal joints.
Design:randomized, controlled, double-blinded study Materials and methods: sixty patients were randomized into: the TH / lidocaine (LD) group (n=30) who underwent IAI at the most symptomatic interphalangeal joint with HT (20mg/ml) and LD 2% or the LD group (n=30) who received IAI with just LD. Patients were assessed at baseline, 1, 4, 8 and 12 weeks by a blinded observer. The following parameters regarding the affected joint were assessed: pain at rest (VASr); pain at movement (VASm); pain (VAS) during the 48 hours after the procedure; swelling (VASs); goniometry; grip and pinch strength; hand function; treatment improvement; daily requirement of paracetamol and incidence and types of local side effects after the procedure.
详细描述
Background The aim of this study was to evaluate the effectiveness and tolerance of medium-term IAI of corticosteroids HT for the treatment of OA in proximal interphalangeal joints(PIP) or distal interphalangeal joints(DIP) joints on clinical and functional parameters.
Studies evaluating the effectiveness of intra-articular therapies in patients with hands OA are very heterogeneous, either by addressing different types of joints at the same time, for wearing unusual drugs, for failing to placebo groups , by using very soluble corticosteroid or not using corticosteroids.
Design A randomized, prospective, controlled, double-blinded, intention to treat study was performed.
Sample Patients were collected from the outpatient clinics of the Federal University of Sao Paulo, from August 2011 to August 2012. A total of 60 patients were randomized into two groups of 30 patients.
The patients had to fulfill the following inclusion criteria: diagnosis of PIP or DIP hands OA according to the American College of Rheumatology criteria, age greater than 40 years, and pain in at least one PIP or DIP hand joints between 3-8 cm on Visual Analog Scale for pain (VAS for pain at rest 0-10cm).
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, Care Provider, 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
- •Age over 40
- •Visual analogic scale (VAS) for pain at rest between 3-8cm
- •Signed informed consent term
排除标准
- •Change in the use of oral corticosteroid or nonsteroidal antiinflammatory (NSAID) in the last 30 days
- •Change in drugs for OA in the last two months
- •IAI in this joints in the last three months
- •Any change in treatment for OA in the hands in the last two months
- •Suspicion of local and or systemic infection, and pregnancy
- •Hands X-ray suggesting arthropathy of the interphalanges of other etiology
- •Serious coagulation disorder
研究组 & 干预措施
IAI triamcinolone hexacetonide
Intra-articular injection with corticosteroid . The study group was called triamcinolone hexacetonide / lidocaine (TH / LD) and a control group, called lidocaine (LD).
Patients in TH / LD group underwent corticosteroid IAI scheme in its most symptomatic interphalangeal (IP) joint composed with triamcinolone hexacetonide(TH) (20mg/ml) and 2% lidocaine without vasoconstrictor. The IAI was realized in the 0.3 ml dose (6mg) of TH for PIP and 0.2 ml (4 mg) of HT for DIP, always associated with 0.1 mL of 2% lidocaine. Paracetamol 750 mg / tablet were also used if required during the 12 weeks of follow-up (up to 03 tablets per day).
干预措施: Intra-articular injection with corticosteroid (Drug)
IAI lidocaine
Intra-articular injection with lidocaine. The LD group patients underwent IAI with only 2% lidocaine without vasoconstrictor in its most symptomatic IP joint. Paracetamol 750 mg / tablet were also used if required during the 12 weeks of follow-up (up to 03 tablets per day) . Both groups of patients underwent only one IAI in the most symptomatic joint and on a single occasion.
干预措施: Intra-articular injection with lidocaine (Drug)
结局指标
主要结局
Change from baseline in Pain Score on the Visual Analogue Scale (VAS) at 3 months
时间窗: 0 -1-4-8 and 12 weeks
To evaluate the improvement on pain measure by:VAS for rest pain (VASr 0- 10cm) and movement (VASm 0- 10cm) in each time
次要结局
- Safety at 3 months(0-1-4-8 and 12 weeks)
研究者
Natalia de Oliva Spolidoro Paschoal
Physician
Federal University of São Paulo