Osteoarthritis, Knee Clinical Trial
— SAPHENEROOfficial 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 .
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | March 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
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/BMR20110277. — View Citation
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. — View Citation
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):481-7. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain scores | Number verbal scale | 90 days | No |
Secondary | Opioids consumption | Morphine oral equivalent dose needed | 90 days | No |
Secondary | Side effects | Nausea, vomiting, sedation | 90 days | No |
Secondary | Functional capacity | WOMAC score | 90 days | No |
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