Effectiveness of Intra-articular Collagen Polyvinylpyrrolidone in Patients With Symptomatic Gonarthross Attended in Rehabilitation of an IMSS-Yucatán Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Number Analog Scale for pain
研究概览
简要总结
The objective of this clinical trial is to verify the effectiveness of polyvinyl pyrrolidone collagen in all patients with symptomatic gonarthrosis grades II-IV in patients over 40 years of age. The main objectives that this study aims to answer are the following:
-
- Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis.
-
- Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention.
-
- Identify demographic, clinical and therapeutic factors that influence the effectiveness of intra-articular PVP collagen in the treatment of symptomatic gonarthrosis.
Patients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service within 3 months, will be selected. Two study groups will be assigned: GROUP those who received intra-articular infiltration of PVP Collagen, GROUP B: patients who received conservative treatment. Through rehabilitation with a home program for one month, in both cases, ENA and the WOMAC scale will be evaluated at the beginning of the study and after 4 weeks.
详细描述
INTRODUCTION
Osteoarthritis is a disorder characterized by progressive deterioration of cartilage in synovial joints, affecting more than 55% of the elderly population, causing significant physical disability, implying a great challenge in medical treatment.
MATERIAL AND METHODS
A sequential, simple randomized clinical trial was carried out in patients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service in 3 months, through two study groups: GROUP Those who received intra-articular infiltration of Collagen PVP, GROUP B: patients who received conservative treatment through rehabilitation with a home program for one month. In both cases, ENA and the WOMAC scale were evaluated at the beginning of the study and at 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 40 years.
- •Both sexes.
- •Joint stiffness less than 30 minutes.
- •Crepitus in the knee joint.
- •Pain in one or both knees lasting more than three months.
- •Continuous pain Quantified in >5 Analog Numerical Scale.
- •Patients entitled to the Mexican Social Security Institute.
- •Radiological criteria for gonarthrosis in phases II, III, IV.
- •Patients not candidates for surgical treatment.
排除标准
- •Rheumatoid arthritis, gout or chondrocalcinosis.
- •Treatment with glucosamine, chondroitin, diacerein, silver non-saponifiables or slow-acting drug in the last three months.
- •Anticoagulant treatment.
- •Paget's disease.
- •Treatment with viscosupplementation in the last six months.
- •Patients not entitled to the Mexican Social Security Institute.
研究组 & 干预措施
GROUP A
Patients who received intra-articular infiltration of PVP Collagen
干预措施: Intra-articular infiltration of PVP Collagen (Other)
GROUP B
Patients who received conservative treatment through rehabilitation with a home program for one month
干预措施: Rehabilitation (Other)
结局指标
主要结局
Number Analog Scale for pain
时间窗: one to three months
number of patients with 0 (none), 1-2 (very mild pain), 3-4 (mild pain), 5-6 (moderate pain), 7-9 (severe non-disabling pain), 10 (worts pain of life, disabling pain)
Western Ontario and McMaster Universities Osteoarthritis Index - Pain
时间窗: One to three months
number of patients with none, little, quite a bit, a lot, very much
Western Ontario and McMaster Universities Osteoarthritis Index - functionality
时间窗: One to three months
number of patients with none, little, quite a bit, a lot, very much
Western Ontario and McMaster Universities Osteoarthritis Index - stiffness
时间窗: One to Three months
number of patientes with none, little, quite a bit, a lot, very much
次要结局
未报告次要终点
研究者
Roberto Carlos Pech Arguelles
Clinical Professor
Instituto Mexicano del Seguro Social