Ultrasound-guided pulsed radiofrequency treatment for knee osteoarthritis
Ultrasound-Guided Pulsed Radiofrequency Of The Genicular Nerves In The Treatment Of Patients With Osteoarthritis Knee Pain: Randomized, Double-Blind, Placebo Controled Trial
This study is testing whether a new ultrasound-guided treatment for knee pain can help people with chronic knee osteoarthritis feel better and use less pain medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Hospital Son Llatzer Academic / other |
| Locations | 1 site (Palma, Balear Islands) |
| Trial ID | NCT02915120 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of ultrasound-guided pulsed radiofrequency treatment on the genicular nerves in patients suffering from chronic knee osteoarthritis. Participants will undergo a double diagnostic genicular nerve block followed by either real or sham pulsed radiofrequency treatment. The primary focus is to assess improvements in pain, function, and reduction in analgesic use over time. Given the increasing prevalence of knee osteoarthritis, this approach seeks to provide an alternative to conventional treatments and surgical options.
Who should consider this trial
Good fit: Ideal candidates are individuals with chronic knee pain due to primary osteoarthritis, experiencing significant pain despite conventional therapies.
Not a fit: Patients with secondary osteoarthritis or those who have had recent corticosteroid injections may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve function for patients with chronic knee osteoarthritis.
How similar studies have performed: Similar studies have shown promising results with ultrasound-guided pulsed radiofrequency, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic knee pain with pain intensity of at least 4 out 10 on the VAS on most or all days for more than 3 months * Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology. * Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2 * Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy. Exclusion Criteria: * The patients with secondary osteoarthritis of knees * Associated systemic arthropathies, e.g. rheumatoid arthritis and gout * Previous radiofrequency ablation treatment for similar symptoms. * Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months. * Active systemic or local infections at the site of proposed needle and electrode placement. * Coagulopathy or other bleeding disorder * Cognitive deficit. * Unstable medical or psychiatric illness. * Previous knee joint replacement surgery * Patients missing two or more appointments consecutively were excluded from the study
Where this trial is running
Palma, Balear Islands
- Son Llatzer University Hospital — Palma, Balear Islands, Spain (Recruiting)
Study contacts
- Principal investigator: Javier Mata, MD — Son Llatzer University Hospital
- Study coordinator: Javier Mata, MD
- Email: jmata@hsll.es
- Phone: 0034871201233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.