Skip to main content
OpenTrials
Completed

NCT Number: NCT02688543

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Painful Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General de Jerez de la Frontera (Servicio Andaluz de Salud)

Jerez de la Frontera, Cadiz, 11407, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RF treatment

Procedure

the genicular nerves are identified with the help of landmarks, ultrasound and nerve stimulation. Once the needle is correctly placed high frequency current is passed through the probe during 90 seconds at 20 V with tip temperature put to 80°C.

radiofrequency ablation

Radiation

Ultrasound

Device

Primary outcomes

  1. Pain reduction

    Time frame: 1, 6 and 12 months

    Pain intensity is measured using a 10-point VAS score

Secondary outcomes

  1. Global patient satisfaction

    Time frame: 1,6 and 12 months

    Satisfaction is scored on a 4-point Likert scale: 1 (poor), 2 (average), 3 (good) and 4 (very good)

  2. Improvement of quality of life

    Time frame: 1,6 and 12 months

    evaluated using the Western Ontario and MacMaster Universities Index of Osteoarthrosis (WOMAC)

Sponsors and collaborators

Lead sponsor

Hospital General de Jerez de la Frontera

Other

Collaborators

  • Ziekenhuis Oost-Limburg

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Feb 23, 2016
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.