Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial (SAPHENERO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02826850|
Recruitment Status : Not yet recruiting
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
This project is one of four components of a thematic project that aims to evaluate the use of ultrasound in regional and infiltration blocks, called "Use of ultrasound in regional blocks and infiltration for the treatment of acute and chronic pain".
It aims to evaluate quantitatively and qualitatively the knee pain control in patients with osteoarthritis after neurotomy by saphenous nerve radiofrequency guided by ultrasound , compared to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy .
Differences between total consumption of analgesics, side effects of medications , impact on quality of life and functional capacity in patients undergoing saphenous nerve neurotomy by radiofrequency guided by ultrasound compared to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy, will also be evaluated.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: Saphenous Nerve Procedure: Genicular nerves||Phase 3|
BACKGROUND: Osteoarthritis of the knees is currently a major public health problem, with patients suffering from pain and functional limitation. Depending on the severity of the impairment, the definitive treatment is surgical, but the old ages often associated and morbidities present in these patients some times limit such conduct. More effective treatments for pain control are necessary.
OBJECTIVES: To evaluate quantitative and qualitative pain control in patients with osteoarthritis in knees after neurotomy of saphenous nerve by radiofrequency guided by ultrasound, compared to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy.
METHODS: This was a prospective, randomized clinical study and blind to the evaluators. Will include 20 patients with knee osteoarthritis grade III or IV, refractory to medical treatment. A group will be submitted to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy and the other group will receive neurotomy by radiofrequency of saphenous nerve, guided by ultrasound. They will be assessed in pain intensity at rest and movement, functionality, satisfaction and adverse effects related to treatment. Patients will be evaluated 15 days, 1 month, 3, 6 and 12 months after the procedure.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Comparative Study of Neurotomy by Radiofrequency of Genicular Nerves, Guided by Fluoroscopy, and Neurotomy by Radiofrequency of Saphenous Nerve, Guided by Ultrasound, for the Treatment of Chronic Knee Pain in Patients With Osteoarthritis .|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||March 2018|
Sham Comparator: Genicular nerves
Neurotomy by radiofrequency of genicular nerves knee guided by fluoroscopy
Procedure: Genicular nerves
Genicular nerves neurotomy by radiofrequency, guided by fluoroscopy
Active Comparator: Saphenous Nerve
Neurotomy of saphenous nerve by radiofrequency on the distal third of the thigh, guided by ultrasound
Procedure: Saphenous Nerve
Saphenous nerve neurotomy by radiofrequency, guided by ultrasound.
- Pain scores [ Time Frame: 90 days ]Number verbal scale
- Opioids consumption [ Time Frame: 90 days ]Morphine oral equivalent dose needed
- Side effects [ Time Frame: 90 days ]Nausea, vomiting, sedation
- Functional capacity [ Time Frame: 90 days ]WOMAC score
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): NCT02826850
|Contact: Hermann S Fernandes, M.D.||+55 84 email@example.com|
|Contact: Shirley A Santos, M.D.||+55 11 firstname.lastname@example.org|
|Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo||Not yet recruiting|
|São Paulo, Brazil, 05403000|
|Contact: Hermann S Fernandes, M.D. +55 84 988966348 email@example.com|
|Contact: Shirley A Santos, M.D. +55 11 985733798 firstname.lastname@example.org|
|Principal Investigator: Hazem A Ashmawi, Ph.D|
|Principal Investigator: Joaquim E Vieira, Ph.D|
|Principal Investigator:||Hazem A Ashmawi, Ph.D||Head of the Pain Management Unit|
|Principal Investigator:||Joaquim E Vieira, Ph.D||Associated Professor of Anesthesiology Department|