Gonarthrosis
Conditions
Keywords
Gonarthrosis, Collagen, Infiltration
Brief summary
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: 1. \- Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis. 2. \- Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention. 3. \- 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.
Detailed description
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.
Interventions
OTHERIntra-articular infiltration of PVP Collagen
Intra-articular collagen injection plus physiotherapy program
OTHERRehabilitation
Patients who received conservative treatment through rehabilitation with a home program for one month
Sponsors
Instituto Mexicano del Seguro Social
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age over 40 years. 2. Both sexes. 3. Joint stiffness less than 30 minutes. 4. Crepitus in the knee joint. 5. Pain in one or both knees lasting more than three months. 6. Continuous pain Quantified in \>5 Analog Numerical Scale. 7. Patients entitled to the Mexican Social Security Institute. 8. Radiological criteria for gonarthrosis in phases II, III, IV. 9. Patients not candidates for surgical treatment.
Exclusion criteria
1. Rheumatoid arthritis, gout or chondrocalcinosis. 2. Treatment with glucosamine, chondroitin, diacerein, silver non-saponifiables or slow-acting drug in the last three months. 4\. Anticoagulant treatment. 5. Paget's disease. 6. Treatment with viscosupplementation in the last six months. 7. Patients not entitled to the Mexican Social Security Institute.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index - Pain | 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 | One to Three months | number of patientes with none, little, quite a bit, a lot, very much |
| Western Ontario and McMaster Universities Osteoarthritis Index - functionality | One to three months | number of patients with none, little, quite a bit, a lot, very much |
| Number Analog Scale for pain | 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) |
Countries
Mexico
Outcome results
None listed