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

NCT02688543 | Completed

• 1 other identifier: RF knee 001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Osteoarthritis of the Knee

Keywords

radio frequency treatment; genicular nerves; osteoarthritis of the knee

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  Pain intensity is measured using a 10-point VAS score

  1, 6 and 12 months

Secondary Outcomes (2)

• Global patient satisfaction

  1,6 and 12 months

• Improvement of quality of life

  1,6 and 12 months

Study Arms (1)

RF treatment

EXPERIMENTAL

Patients treated with radio frequency of the genicular nerves

Procedure: RF treatment; Radiation: radiofrequency ablation; Device: ultrasound

Interventions

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.

RF treatment

radiofrequency ablation RADIATION

RF treatment

ultrasound DEVICE

RF treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General de Jerez de la Frontera: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

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

Jerez de la Frontera, Cadiz, 11407, Spain

Location

Related Publications (1)

• 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.

  PMID: 27875368 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Radiofrequency Ablation; Ultrasonography

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 23, 2016
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: January 1, 2016
• Last Updated: February 23, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)