NCT01226615Unknown4 期
Randomized, Double-blind, Placebo-controlled Study to Asses the Effect of Chondroitin Sulphate in Patients With Knee Osteoarthritis by Functional Magnetic Resonance Imaging
Bioiberica1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2010年10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
- 64
- 试验地点
- 1
- 主要终点
- Brain response to pain caused on arthritic knee selected by fMRI
研究概览
简要总结
The main purposes of this study are:
- to determine the effects of chondroitin sulphate on brain response to pain assessed through fMRI in patients with knee osteoarthritis.
- to investigate the relationship between treatment response detected by fMRI and the results of the different parameters of clinical assessment.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary knee OA according to ACR criteria
- •OA of radiological stages 2 to 3 according to Kellgren-Lawrence
- •Estable knee pain during the last months before to start the clinical trial
- •Patients with pain as the VAS≥50mm at baseline
排除标准
- •Patients with skin conditions that could interfere in the clinical trial evaluation
- •Pregnant or breastfeeding woman
- •Patients with a history of alcoholism or other drug abuse
- •Patients with an uncontrolled active psychiatric disorder
- •Patients with other inflammatory or systemic conditions affecting other joints
- •Patients who suffer more intense pain in the joint in another location
- •Patients unable to differentiate between symptoms caused by the knee in front of the joint study opposite
- •OA of radiological stages 1 or 4 according to Kellgren-Lawrence
- •Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis
- •Patients with contraindications to perform an MRI such as: certain tattoos, pacemakers, intracranial clips incompatible with MRI, in the heart valves, hearing aids and other types of implants are incompatible with MRI
- •Known allergy to chondroitin sulphate
- •Washout period for OA treatments before beginning the study
研究组 & 干预措施
1
Experimental
Chondroitin sulphate
干预措施: Chondroitin sulphate (Condrosan®) (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Brain response to pain caused on arthritic knee selected by fMRI
时间窗: 4 months
Functional magnetic resonance imaging (fMRI) is particularly suited to investigating the effects of pharmacological agents on pain processing within the human central nervous system. The measures are based on the haemodynamic resonse to a neuronal event and constitute indirect measures of excitatory and inhibitory neuronal activity. The neuronal activation is associated with an increase of the oxygen extraction fraction from the capillaries and with an increase in regional cerebral blood flow. The measure which derived from blood oxygenation is called the BOLD effect.
次要结局
- Assessment of the reduction of pain by Huskisson VAS(4 months)
- Determination of pain and functional capacity using the Lequesne Algofunctional Index(4 months)
- Use of rescue medication(4 months)
- Assessment of the quality of life of patients by SF-36 Health Questionaire(4 months)
研究者
研究点 (1)
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