Nctid:
NCT06613815
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M12926", "name"=>"Osteoarthritis", "relevance"=>"LOW"}, {"id"=>"M22168", "name"=>"Osteoarthritis, Knee", "relevance"=>"LOW"}, {"id"=>"M29442", "name"=>"Chronic Pain", "relevance"=>"LOW"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>57}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2019-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The main variable was the measurement of pain intensity assessed by the NRS (Numerical Rating Scale) at different moments: baseline and at 3, 6 and 12 months after performing the technique.", "timeFrame"=>"January 2019-January 2024", "description"=>"The main variable was the measurement of pain intensity assessed by the NRS (Numerical Rating Scale) at different moments: baseline and at 3, 6 and 12 months after performing the technique. As secondary variables, the reduction in opioid requirements were registered."}], "secondaryOutcomes"=>[{"measure"=>"As secondary variables, the reduction in opioid requirements were registered.", "timeFrame"=>"January 2019-January 2024", "description"=>"As secondary variables, the reduction in opioid requirements were registered."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["knee osteoarthritis, conventional radiofrequency, geniculated nerves, chronic pain."], "conditions"=>["Knee Osteoarthritisorconventional Radiofrequencyandgeniculated Nerves"]}, "descriptionModule"=>{"briefSummary"=>"Knee osteoarthritis is one of the most common joint conditions in the elderly population, characterized by causing pain, stiffness and functional disability in a significant number of cases.\n\nRetrospective, non-randomized observational study, between January 2019 and January 2024, comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) versus the ultrasound-guided technique (US group, N=38) in patients referred to the pain unit for chronic gonalgia of moderate-severe intensity after knee surgery.\n\nThe main variable studied was the measurement of pain intensity according to the numerical rating scale (NRS) before performing the technique and at 3, 6 and 12 months after radiofrequency denervation of the geniculate nerves.\n\nConventional radiofrequency of the geniculate nerves of the knee significantly reduces pain intensity over a period of at least 6 to 12 months in patients with chronic postoperative gonalgia, with the ultrasound-guided technique presenting the lowest scores on the numerical pain scale.\n\nIt is a simple technique to perform and with few adverse effects, which allows patients to reduce the dose of opioid drugs they take chronically.", "detailedDescription"=>"Knee osteoarthritis is one of the most common joint conditions in the elderly population, characterized by causing pain, stiffness and functional disability in a significant number of cases.\n\nRetrospective, non-randomized observational study, between January 2019 and January 2024, comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) versus the ultrasound-guided technique (US group, N=38) in patients referred to the pain unit for chronic gonalgia of moderate-severe intensity after knee surgery.\n\nThe main variable studied was the measurement of pain intensity according to the numerical rating scale (NRS) before performing the technique and at 3, 6 and 12 months after radiofrequency denervation of the geniculate nerves.\n\nThe following were measured as secondary variables: the degree of motor block, the reduction in the consumption of opioid drugs, the ease of performing the technique, the degree of patient satisfaction, the appearance of adverse effects and complications related to the technique.\n\nA total of 57 patients were included in the study (19 scopic group and 38 US group). Both techniques were shown to be effective for the control of chronic knee pain. There was a statistically significant reduction in pain intensity at 3, 6 and 12 months (3 \\[1-5\\] vs 2 \\[0-3\\]; p=0.02 / 3 \\[2-5\\] vs 2 \\[0-3\\]; p=0.00 / 4 \\[2-5\\] vs 2 \\[1-3\\]; p=0.00), as well as a reduction in minor opioid requirements (52.6% vs 18.4% p=0.001) in the ultrasound-guided group. No statistical differences were observed between the two groups in terms of the consumption of major opioids or complications of the technique, except for a higher incidence of motor block in the ultrasound-guided group (Bromage scale II: 0% vs 13.2%, p=0.15), which was not clinically relevant.\n\nThe degree of patient satisfaction was high in both groups, with no differences being found.Conventional radiofrequency of the geniculate nerves of the knee significantly reduces pain intensity over a period of at least 6 to 12 months in patients with chronic postoperative gonalgia, with the ultrasound-guided technique presenting the lowest scores on the numerical pain scale.\n\nIt is a simple technique to perform and with few adverse effects, which allows patients to reduce the dose of opioid drugs they take chronically."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Due to the reason that it is a retrospective study, sample size calculation was not performed and all patients who underwent this analgesic technique in the last 5 years were consecutively included.\n\nContinuous quantitative variables were expressed as mean and standard deviation, and the results were contrasted using the Student's T test if data reached normality criteria. Otherwise, they were expressed as median and range and contrasted using the Mann-Whitney U-test. Qualitative variables were expressed in absolute numbers and relative frequencies, and data were contrasted using the Chi square and Fisher's test when necessary. Normality tests were conducted for all continuous quantitative variables. The data were processed using SPSS software version 20.0 (IBM Corporation, Armonk, NY, USA), assuming a p-value below 0.05 as significant.", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* people over 18 years of age,physical status ASA I - III, suffering postsurgical chronic Knee pain for more than 3 months, with a baseline pain scale score (NRS) \\>5 points and failure of other conservative treatments (painkillers, rehabilitation and intraarticular infiltration).\n\nExclusion Criteria:\n\n* any contraindication for performing regional techniques (infection at the puncture point, alteration of haemostasis, allergy to local anesthetics), pacemaker carriers, non-approval of informed consent, inability to assess postoperative pain, cognitive impairment and known neuropathy of the operated limb."}, "identificationModule"=>{"nctId"=>"NCT06613815", "briefTitle"=>"EFFECTIVENESS OF CONVENTIONAL RADIOFREQUENCY OF THE GENICULAR NERVES GUIDED BY SCOPIC VERSUS ULTRASOUND FOR THE TREATMENT OF POSTQUIRURGICAL GONALGIA", "organization"=>{"class"=>"OTHER", "fullName"=>"Fundación Pública Galega Instituto de Investigación Sanitaria."}, "officialTitle"=>"EFFECTIVENESS OF CONVENTIONAL RADIOFREQUENCY OF THE GENICULATED NERVES GUIDED BY SCOPIC VERSUS ULTRASOUND IMAGING FOR THE TREATMENT OF POSTQUIRURGICAL GONALGIA: A RETROSPECTIVE OBSERVATIONAL STUDY", "orgStudyIdInfo"=>{"id"=>"nº 2024/211"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"(scopic group, N=19)", "description"=>"comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19)", "interventionNames"=>["Other: radiofrequency of the geniculate nerves"]}, {"label"=>"the ultrasound-guided technique (US group, N=38)", "description"=>", comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) versus the ultrasound-guided technique", "interventionNames"=>["Other: radiofrequency of the geniculate nerves"]}], "interventions"=>[{"name"=>"radiofrequency of the geniculate nerves", "type"=>"OTHER", "description"=>"radiofrequency of the geniculate nerveswith a scopy-guided technique versus the ultrasound-guided technique", "armGroupLabels"=>["(scopic group, N=19)", "the ultrasound-guided technique (US group, N=38)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"27003", "city"=>"Lugo", "country"=>"Spain", "facility"=>"Álvaro Manuel Gasalla Cadórniga", "geoPoint"=>{"lat"=>43.00992, "lon"=>-7.55602}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fundación Pública Galega Instituto de Investigación Sanitaria.", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Specialist doctor in area", "investigatorFullName"=>"ÁLVARO MANUEL GASALLA CADÓRNIGA", "investigatorAffiliation"=>"Fundación Pública Galega Instituto de Investigación Sanitaria."}}}}
