Radiofrequency Ablation of Genicular Nerves for Advanced Osteoarthrosis of the Knee Joint 1 Year Follow-up.

Not Applicable

Completed

• Conditions: Painful Osteoarthritis of the Knee
• Interventions: Procedure: RF treatment; Radiation: radiofrequency ablation; Device: ultrasound

• Registration Number: NCT02688543
• Lead Sponsor: Hospital General de Jerez de la Frontera

Brief Summary

Pharmacological treatment of pain due to osteoarthritis of the knee often proves to be inadequate and/or cause intolerable side effects. Arthroplasty of the knee may offer a solution, but waiting lists may be long or certain patients may not be apt for a surgical intervention. Therefore an alternative pain treatment that is effective and has little side effects allowing to offer pain relief to those difficult to manage patients would be an added value in the therapeutic options.

We studies the short and long-term effects of radio frequency treatment of the genicular nerves in patients with severe pain due to osteoarthritis of the knee.

Detailed Description

Radio frequency treatment (RF) of the genicular nerves was found to be effective in a randomized controlled trial. Because of the blinding patients were allowed to continue pre-intervention pharmacological treatment, which may have interfered with the outcome. The short follow-up (12 weeks) does not allow drawing conclusion on the duration of the effect.

We aimed at assessing the pain reducing effect of RF of the genicular nerves and the duration of the effect.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-03
• Study Completion: 2016-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-22
• Last Update Submitted: 2016-02-22
• Study First Posted: 2016-02-23
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

• patients suffering from pain caused by osteoarthrosis of the knee joint
• osteoarthrosis of the knee joint (grade 3-4 according to the Kellgren Lawrence classification)
• pain of moderate to severe intensity (VAS≥5, on a 10-point scale) during >3 months
• pain resistant to conservative treatments

Exclusion Criteria

• acute knee pain associated with radicular neuropathy or intermittent claudication, connective tissue diseases affecting the knee, serious neurologic or psychiatric disorders, mental deterioration impeding adequate communication or collaboration, injection with steroids or hyaluronic acids during the previous 3 months, anticoagulant medications, pacemakers, and prior electro-acupuncture treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RF treatment	radiofrequency ablation	Patients treated with radio frequency of the genicular nerves
RF treatment	ultrasound	Patients treated with radio frequency of the genicular nerves
RF treatment	RF treatment	Patients treated with radio frequency of the genicular nerves

Primary Outcome Measures

Name	Time	Method
Pain reduction	1, 6 and 12 months	Pain intensity is measured using a 10-point VAS score

Secondary Outcome Measures

Name	Time	Method
Global patient satisfaction	1,6 and 12 months	Satisfaction is scored on a 4-point Likert scale: 1 (poor), 2 (average), 3 (good) and 4 (very good)
Improvement of quality of life	1,6 and 12 months	evaluated using the Western Ontario and MacMaster Universities Index of Osteoarthrosis (WOMAC)

Trial Locations

Locations (1)

Hospital General de Jerez de la Frontera (Servicio Andaluz de Salud); 🇪🇸 Jerez de la Frontera, Cadiz, Spain