Moderated osteoarthritis of the knee joint Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either sex will participate in the clinical trial as long as they have: 1. The NICE clinical criteria of primary knee OA for one or both knees: 1.1. Age >45 years 1.2. Activity-related joint pain 1.3. No morning joint stiffness or morning stiffness that lasts no longer than 30 minutes 2. Radiological confirmation of knee arthritis (grade =2) according to the Kellgren and Lawrence classification 3. Chronic knee pain for a minimum duration of 6 months 4. Pain intensity =4 on the (NRPS) 5. Lack of pain relief from conventional therapy, including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy. 6. The ability to communicate in Greek
Exclusion criteria
Exclusion criteria: 1. inflammatory or post-traumatic knee arthritis 2. Patients who have received CRFA treatment in the past 3. Injection of hyaluronic acid or corticosteroid within the previous 3 months 4. Significant structural deformities affecting locomotion and knee function aside from osteoarthritis and which might cause chronic knee pain 5. Body mass index =40 kg/m² 6. Uncontrolled serious disease (cancer, diabetes, end-stage heart disease etc) 7. Unstable psychiatric illness 8. Coagulopathy or bleeding disorders 9. Active systemic or local infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain associated with knee OA measured using the Numerical Rating Pain Scale (NRPS) at 1, 3, and 6-month post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the interventions, and patient’s clinical outcome measured using the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR), the Oxford Knee Score (OKS), the SF-12 and the Forgotten Joint Score (FJS) at 1-, 3- and 6-months post-intervention | — |
Countries
Greece