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Management of pain in the arthritic knee

Cooled radiofrequency ablation versus cryoneurolysis for the symptomatic management of pain in knee osteoarthritis: a prospective, randomized, sham-controlled, double-blind trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87455770
Enrollment
60
Registered
2022-03-29
Start date
2022-04-15
Completion date
Unknown
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relief of pain related to knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]

Interventions

one dose of third-generation cephalosporin will be given for infection prophylaxis. Patients would be continuously monitored and given conscious sedation (1–2 mg IV and/or fentanyl (25–100 mcg IV)) an
Approximately 400 patients with symptomatic knee OA visit the clinic each year. A small percentage has an end-stage disease, only amenable for total knee replacement. Most of the remaining patients re

Sponsors

General University Hospital of Patras
Lead Sponsor

Eligibility

Sex/Gender
All

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. A decrease of =50% in NRPS scores with diagnostic genicular nerve block 6. The ability to communicate in Greek

Exclusion criteria

Exclusion criteria: 1. inflammatory or post-traumatic knee arthritis 2. Patients who have received CRYON or 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 10. Disease-associated with reactions to cold, such as cryoglobulinemia

Design outcomes

Primary

MeasureTime frame
Pain associated with knee OA measured using the Numerical Rating Pain Scale (NRPS) at 2-, 4- 12- and 24-weeks post-intervention

Secondary

MeasureTime frame
Safety, tolerability and the patient’s clinical outcome measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) the Oxford Knee Score (OKS) and the Patient Global Impression of Change (PGIC) 7-point scale at 12- and 24-weeks post-intervention

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 22, 2026