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Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial (SAPHENERO)

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ClinicalTrials.gov Identifier: NCT02826850
Recruitment Status : Not yet recruiting
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Hermann dos Santos Fernandes, University of Sao Paulo General Hospital

Brief Summary:

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Pain scores [ Time Frame: 90 days ]
    Number verbal scale


Secondary Outcome Measures :
  1. Opioids consumption [ Time Frame: 90 days ]
    Morphine oral equivalent dose needed

  2. Side effects [ Time Frame: 90 days ]
    Nausea, vomiting, sedation

  3. Functional capacity [ Time Frame: 90 days ]
    WOMAC score



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Will be included patients older than 18 years, who have moderate to strong chronic pain in knee on most of the days days for at least 3 months, with osteoarthritis of the knee documented by graded radiologically at 3 to 4 in Kellgren-Lawrence rating, refractory to medical treatment (physical therapy, oral analgesics, intra-articular injections of hyaluronic acid or corticosteroids).

Exclusion Criteria:

  • The exclusion criteria are: acute knee pain, prior surgery on the knee, another connective tissue disease affecting the knee, psychiatric or neurological disorders, intra-articular injection of hyaluronic acid or corticosteroid for less than 3 months, pain related to nerve sciatic, use of anticoagulants and pacemaker.

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): NCT02826850


Contacts
Contact: Hermann S Fernandes, M.D. +55 84 988966348 hermann.fernandes@hc.fm.usp.br
Contact: Shirley A Santos, M.D. +55 11 985733798 shirleyandrade.s@gmail.com

Locations
Brazil
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    hermann.fernandes@hc.fm.usp.br   
Contact: Shirley A Santos, M.D.    +55 11 985733798    shirleyandrade.s@gmail.com   
Principal Investigator: Hazem A Ashmawi, Ph.D         
Principal Investigator: Joaquim E Vieira, Ph.D         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Hermann dos Santos Fernandes, M.D., University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02826850     History of Changes
Other Study ID Numbers: CAAE: 55153516.0.0000.0068
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Hermann dos Santos Fernandes, University of Sao Paulo General Hospital:
Osteoarthritis, Knee
Pulsed Radiofrequency Treatment
Ultrasonography, Interventional

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases