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

Painful Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688543
• Other study ID #: RF knee 001
• Status: Completed
• Phase: N/A
• First received: February 18, 2016
• Last updated: February 22, 2016
• Start date: March 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Hospital General de Jerez de la Frontera
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Knee
• Painful Osteoarthritis of the Knee

Intervention

Procedure:
• RF treatment
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.

Radiation:
• radiofrequency ablation

Device:
• ultrasound

Locations

Country	Name	City	State
Spain	Hospital General de Jerez de la Frontera (Servicio Andaluz de Salud)	Jerez de la Frontera	Cadiz

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General de Jerez de la Frontera	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction	Pain intensity is measured using a 10-point VAS score	1, 6 and 12 months	No
Secondary	Global patient satisfaction	Satisfaction is scored on a 4-point Likert scale: 1 (poor), 2 (average), 3 (good) and 4 (very good)	1,6 and 12 months	No
Secondary	Improvement of quality of life	evaluated using the Western Ontario and MacMaster Universities Index of Osteoarthrosis (WOMAC)	1,6 and 12 months	No