NCT01233739Unknown4 期
Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis. Measurement With Sensory and Quantitive Functional Tests and Concordance Analysis With Subjective Scales of Pain.
Juan A. Arnaiz1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Evaluation with visual analogue pain scale as mean at the last weak
研究概览
简要总结
Patients who present rhizarthrosis diagnostic will be randomized to be treated with chondroitin sulfate or placebo during 24 weeks to study the effect of the treatment with objective and subjective indicators of pain and sensibility.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both sex patients
- •age between 45 to 75 years
- •with mechanical pain at the trapezium-thumb metacarpal joint of more than 3 months duration
- •grade II or III Eaton & Glickel rhizarthrosis radiological diagnose
- •pain at inclusion of >= 40 mm at a visual analogue scale
- •without rehabilitation treatment or infiltration in the last 6 months
- •who accept to participate and sign informed consent
排除标准
- •patients with rhizarthrosis resulted from rheumatic disease
- •patients with joint surgery or traumatic background
- •illiterate patients or unable to understand informed consent
- •patients with previous neuropsychopathology enough severe to unable participation at the study
- •patients with peripheral sensory impairment due to diabetes, peripheral neuropathy or central neurological sequelae of disease in the affected limb that can alter sensory perception
- •patients with coagulopathy
- •inflammation for other process at the joint at study
- •in treatment with non-steroidal anti-inflammatory drug in the last 7 days and/or corticosteroid in the last 30 days
- •allergy or hypersensibility at chondroitin sulfate or its excipients
- •pregnant or breastfeeding woman
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Chondroitin sulfate
Experimental
Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
干预措施: Chondroitin sulfate (Drug)
结局指标
主要结局
Evaluation with visual analogue pain scale as mean at the last weak
时间窗: 36 weeks
次要结局
- SF-12 test(36 weeks)
- Thumb-index finger pincer force(36 weeks)
- Dash test(36 weeks)
- Sollerman test(36 weeks)
- Hand pressure force(36 weeks)
- Mechanical sensitivity measured with electronic Von Frey filament(36 weeks)
- vibratory and thermic sensibility threshold assisted by computer(36 weeks)
- Use of paracetamol or other analgesic drugs(36 weeks)
- Evolution of trapezium-thumb metacarpal joint by ultrasound scan(36 weeks)
- Hematologic evaluation(24 weeks)
- Biochemical evaluation(24 weeks)
研究者
Juan A. Arnaiz
MD, PhD
Hospital Clinic of Barcelona
研究点 (1)
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