Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial
NCT ID: NCT02826850
Last Updated: 2016-07-11
Study Results
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Basic Information
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UNKNOWN
PHASE3
20 participants
INTERVENTIONAL
2016-09-30
2018-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Genicular nerves
Neurotomy by radiofrequency of genicular nerves knee guided by fluoroscopy
Genicular nerves
Genicular nerves neurotomy by radiofrequency, guided by fluoroscopy
Saphenous Nerve
Neurotomy of saphenous nerve by radiofrequency on the distal third of the thigh, guided by ultrasound
Saphenous Nerve
Saphenous nerve neurotomy by radiofrequency, guided by ultrasound.
Interventions
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Saphenous Nerve
Saphenous nerve neurotomy by radiofrequency, guided by ultrasound.
Genicular nerves
Genicular nerves neurotomy by radiofrequency, guided by fluoroscopy
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Hermann dos Santos Fernandes
M.D.
Principal Investigators
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Hazem A Ashmawi, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Head of the Pain Management Unit
Joaquim E Vieira, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Associated Professor of Anesthesiology Department
Locations
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Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Mannoni 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.
Felson 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.
Ikeuchi 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.
Choi 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.
Akbas 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.
Jin 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.
Study Documents
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Document Type: Study Protocol
View DocumentDocument Type: Informed Consent Form
View DocumentOther Identifiers
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CAAE: 55153516.0.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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