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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Pain reduction [ Time Frame: 1, 6 and 12 months ]Pain intensity is measured using a 10-point VAS score
- 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)
- Improvement of quality of life [ Time Frame: 1,6 and 12 months ]evaluated using the Western Ontario and MacMaster Universities Index of Osteoarthrosis (WOMAC)
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
|Hospital General de Jerez de la Frontera (Servicio Andaluz de Salud)|
|Jerez de la Frontera, Cadiz, Spain, 11407|