Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial
SAPHENERO
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 .
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedJuly 11, 2016
July 1, 2016
1 year
July 5, 2016
July 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain scores
Number verbal scale
90 days
Secondary Outcomes (3)
Opioids consumption
90 days
Side effects
90 days
Functional capacity
90 days
Study Arms (2)
Genicular nerves
SHAM COMPARATORNeurotomy by radiofrequency of genicular nerves knee guided by fluoroscopy
Saphenous Nerve
ACTIVE COMPARATORNeurotomy of saphenous nerve by radiofrequency on the distal third of the thigh, guided by ultrasound
Interventions
Saphenous nerve neurotomy by radiofrequency, guided by ultrasound.
Genicular nerves neurotomy by radiofrequency, guided by fluoroscopy
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403000, Brazil
Related Publications (7)
Andrianakos AA, Kontelis LK, Karamitsos DG, Aslanidis SI, Georgountzos AI, Kaziolas GO, Pantelidou KV, Vafiadou EV, Dantis PC; ESORDIG Study Group. Prevalence of symptomatic knee, hand, and hip osteoarthritis in Greece. The ESORDIG study. J Rheumatol. 2006 Dec;33(12):2507-13.
PMID: 17143985BACKGROUNDMannoni A, Briganti MP, Di Bari M, Ferrucci L, Costanzo S, Serni U, Masotti G, Marchionni N. Epidemiological profile of symptomatic osteoarthritis in older adults: a population based study in Dicomano, Italy. Ann Rheum Dis. 2003 Jun;62(6):576-8. doi: 10.1136/ard.62.6.576.
PMID: 12759299BACKGROUNDFelson DT, Naimark A, Anderson J, Kazis L, Castelli W, Meenan RF. The prevalence of knee osteoarthritis in the elderly. The Framingham Osteoarthritis Study. Arthritis Rheum. 1987 Aug;30(8):914-8. doi: 10.1002/art.1780300811.
PMID: 3632732BACKGROUNDIkeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.
PMID: 21463469BACKGROUNDChoi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
PMID: 21055873BACKGROUNDAkbas M, Luleci N, Dere K, Luleci E, Ozdemir U, Toman H. Efficacy of pulsed radiofrequency treatment on the saphenous nerve in patients with chronic knee pain. J Back Musculoskelet Rehabil. 2011;24(2):77-82. doi: 10.3233/BMR-2011-0277.
PMID: 21558611BACKGROUNDJin SQ, Ding XB, Tong Y, Ren H, Chen ZX, Wang X, Li Q. Effect of saphenous nerve block for postoperative pain on knee surgery: a meta-analysis. Int J Clin Exp Med. 2015 Jan 15;8(1):368-76. eCollection 2015.
PMID: 25785007BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
July 5, 2016
First Posted
July 11, 2016
Study Start
September 1, 2016
Primary Completion
September 1, 2017
Study Completion
March 1, 2018
Last Updated
July 11, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share