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

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ClinicalTrials.gov Identifier: NCT02688543
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Ziekenhuis Oost-Limburg
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Painful Osteoarthritis of the Knee Procedure: RF treatment Radiation: radiofrequency ablation Device: ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: RF treatment
Patients treated with radio frequency of the genicular nerves
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



Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 1, 6 and 12 months ]
    Pain intensity is measured using a 10-point VAS score


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688543


Locations
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Spain
Hospital General de Jerez de la Frontera (Servicio Andaluz de Salud)
Jerez de la Frontera, Cadiz, Spain, 11407
Sponsors and Collaborators
Hospital General de Jerez de la Frontera
Ziekenhuis Oost-Limburg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital General de Jerez de la Frontera
ClinicalTrials.gov Identifier: NCT02688543    
Other Study ID Numbers: RF knee 001
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospital General de Jerez de la Frontera:
radio frequency treatment
genicular nerves
osteoarthritis of the knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases