Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-03-12 @ 7:41 AM
Study NCT ID:
NCT02826850
Status:
UNKNOWN
Last Update Posted:
2016-07-11
First Post:
2016-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': '90 days', 'description': 'Number verbal scale'}], 'secondaryOutcomes': [{'measure': 'Opioids consumption', 'timeFrame': '90 days', 'description': 'Morphine oral equivalent dose needed'}, {'measure': 'Side effects', 'timeFrame': '90 days', 'description': 'Nausea, vomiting, sedation'}, {'measure': 'Functional capacity', 'timeFrame': '90 days', 'description': 'WOMAC score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoarthritis, Knee', 'Pulsed Radiofrequency Treatment', 'Ultrasonography, Interventional'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'availIpds': [{'url': 'http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisaAgrupador.jsf#', 'type': 'Study Protocol'}, {'url': 'http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisaAgrupador.jsf#', 'type': 'Informed Consent Form'}], 'references': [{'pmid': '17143985', 'type': 'BACKGROUND', '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.'}, {'pmid': '12759299', 'type': 'BACKGROUND', '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. doi: 10.1136/ard.62.6.576.'}, {'pmid': '3632732', 'type': 'BACKGROUND', '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. doi: 10.1002/art.1780300811.'}, {'pmid': '21463469', 'type': 'BACKGROUND', '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.'}, {'pmid': '21055873', 'type': 'BACKGROUND', '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):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.'}, {'pmid': '21558611', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25785007', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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".\n\nIt 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 .\n\nDifferences 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.', 'detailedDescription': '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.\n\nOBJECTIVES: 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.\n\nMETHODS: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT02826850', 'acronym': 'SAPHENERO', 'briefTitle': 'Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': '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 .', 'orgStudyIdInfo': {'id': 'CAAE: 55153516.0.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Genicular nerves', 'description': 'Neurotomy by radiofrequency of genicular nerves knee guided by fluoroscopy', 'interventionNames': ['Procedure: Genicular nerves']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saphenous Nerve', 'description': 'Neurotomy of saphenous nerve by radiofrequency on the distal third of the thigh, guided by ultrasound', 'interventionNames': ['Procedure: Saphenous Nerve']}], 'interventions': [{'name': 'Saphenous Nerve', 'type': 'PROCEDURE', 'description': 'Saphenous nerve neurotomy by radiofrequency, guided by ultrasound.', 'armGroupLabels': ['Saphenous Nerve']}, {'name': 'Genicular nerves', 'type': 'PROCEDURE', 'description': 'Genicular nerves neurotomy by radiofrequency, guided by fluoroscopy', 'armGroupLabels': ['Genicular nerves']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Hermann S Fernandes, M.D.', 'role': 'CONTACT', 'email': 'hermann.fernandes@hc.fm.usp.br', 'phone': '+55 84 988966348'}, {'name': 'Shirley A Santos, M.D.', 'role': 'CONTACT', 'email': 'shirleyandrade.s@gmail.com', 'phone': '+55 11 985733798'}, {'name': 'Hazem A Ashmawi, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joaquim E Vieira, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Hermann S Fernandes, M.D.', 'role': 'CONTACT', 'email': 'hermann.fernandes@hc.fm.usp.br', 'phone': '+55 84 988966348'}, {'name': 'Shirley A Santos, M.D.', 'role': 'CONTACT', 'email': 'shirleyandrade.s@gmail.com', 'phone': '+55 11 985733798'}], 'overallOfficials': [{'name': 'Hazem A Ashmawi, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of the Pain Management Unit'}, {'name': 'Joaquim E Vieira, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associated Professor of Anesthesiology Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Hermann dos Santos Fernandes', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}