Clinical trial NCT02688543: Radiofrequency Ablation of Genicular Nerves for Advanced Osteoarthrosis of the Knee Joint 1 Year Follow-up.
Official title: Analgesic Effect and Functional Improvement Caused by Radiofrequency Ablation of Genicular Nerves in Patients With Advanced Osteoarthrosis of the Knee Joint Until 1 Year Following Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Painful Osteoarthritis of the Knee
Keywords: radio frequency treatment
genicular nerves
osteoarthritis of the knee
Lead sponsor: Hospital General de Jerez de la Frontera
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2016-02-23
Enrollment: 25
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain reduction
timeFrame: 1, 6 and 12 months
Secondary outcomes:
measure: Global patient satisfaction
timeFrame: 1,6 and 12 months
measure: Improvement of quality of life
timeFrame: 1,6 and 12 months
Other outcomes:
Locations:
city: Jerez de la Frontera
country: Spain
facility: Hospital General de Jerez de la Frontera (Servicio Andaluz de Salud)
state: Cadiz
Study officials:
References:
citation: Santana Pineda MM, Vanlinthout LE, Moreno Martin A, van Zundert J, Rodriguez Huertas F, Novalbos Ruiz JP. Analgesic Effect and Functional Improvement Caused by Radiofrequency Treatment of Genicular Nerves in Patients With Advanced Osteoarthritis of the Knee Until 1 Year Following Treatment. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):62-68. doi: 10.1097/AAP.0000000000000510.