Skip to content

Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial

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 .

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02826850
Acronym
SAPHENERO
Enrollment
20
Registered
2016-07-11
Start date
2016-09-30
Completion date
2018-03-31
Last updated
2016-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee, Pulsed Radiofrequency Treatment, Ultrasonography, Interventional

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.

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.

Interventions

PROCEDURESaphenous Nerve

Saphenous nerve neurotomy by radiofrequency, guided by ultrasound.

PROCEDUREGenicular nerves

Genicular nerves neurotomy by radiofrequency, guided by fluoroscopy

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain scores90 daysNumber verbal scale

Secondary

MeasureTime frameDescription
Opioids consumption90 daysMorphine oral equivalent dose needed
Side effects90 daysNausea, vomiting, sedation
Functional capacity90 daysWOMAC score

Countries

Brazil

Contacts

Primary ContactHermann S Fernandes, M.D.
hermann.fernandes@hc.fm.usp.br+55 84 988966348
Backup ContactShirley A Santos, M.D.
shirleyandrade.s@gmail.com+55 11 985733798

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026