Osteoarthritis of Knee Clinical Trial
Official title:
Correlation Between Serum Nesfatin-1 and Human Cartilage Glycoprotein-39 (YKL-40) Levels and Ultrasonographic Findings in Patients With Knee Osteoarthritis, Effect of Platelet Rich Plasma Treatment on Serum YKL-40 and Nesfatin-1 Levels
Verified date | February 2024 |
Source | Kayseri City Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, our objective was to assess the correlation between serum human cartilage glycoprotein-39 (YKL-40) and nesfatin-1 values, the patient's clinical condition, ultrasonographic cartilage thickness measurements, and the response to PRP treatment in knee osteoarthritis (OA)
Status | Completed |
Enrollment | 30 |
Est. completion date | December 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Having patient consent, - Having stage 2-3 knee osteoarthritis according to the Kellgren-Lawrence scale, - Being diagnosed with knee osteoarthritis according to ACR (American college of Rheumatology), - Being over the age of 18 - under the age of 75, - Having NRS 4 and above Exclusion Criteria: - Those who have had knee surgery before, - Those who have had any local injections such as physical therapy, intra-articular steroid or hyaluronic acid injection in the knee area in the last 3 months, - Malignancies, - Those with local infection, wound, scar in the relevant area, - Infections, Hepatitis, Immunosuppression, - Inflammatory arthropathies, - Uncontrolled Hypertension, uncontrolled Diabetes Mellitus, decompensated heart failure, coronary artery disease, asthma - Recent trauma, - Epileptic patients, - Pregnant women, - Corticosteroid use, - Avascular necrosis - Anemia, bleeding coagulation disorder |
Country | Name | City | State |
---|---|---|---|
Turkey | Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital | Kayseri |
Lead Sponsor | Collaborator |
---|---|
Kayseri City Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Serum YKL-40 levels | It will be evaluated before and after exercise and before and after PRP. 0-14-28. day | before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). | |
Primary | Change in Serum nesfatin-1 levels | It will be evaluated before and after exercise and before and after PRP. 0-14-28. day | before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). | |
Primary | NRS pain score | Numerical Rating Scale (NRS), is basically any scale that renders a quantitative symbolization of an attribute. This type of scale is used by presenting the respondent with an ordered set from which to choose, for example, 1 to 10, coupled with anchors.The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable. | before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). | |
Primary | WOMAC score | It is a disease-specific measurement for knee and hip osteoarthritis. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a personalized index with 5 questions for pain, 2 for stiffness, and 17 questions for questioning daily activities. It has different scores from 0 to 4 (0: none, 1: mild, 2: moderate, 3: severe, 4: very severe). Scale lengths of subheadings; pain=20, stiffness=8, physical function=68. Turkish validation is available . A high score indicates poor health. | before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). | |
Primary | 6 minutes walking test | It is a test used to reveal submaximal functional performance. The test should be performed in a closed, quiet environment of at least 30 meters, marked every 3 meters, and in a straight corridor. The patient should be warned to wear comfortable clothes and suitable shoes. The turning points during walking should be marked with the help of a cone and the patient should be asked to go around this cone. The test is terminated by calculating the total distance walked in six minutes.A low score indicates poor health. | before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). | |
Primary | Cartilage thickness measurement with USG | Cartilage thickness measurements (millimeter) were measured in the medial and lateral facets where the cartilage was thickest and averaged with ultrasonography. | before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). |
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