Nctid:
NCT06225583
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000013577", "term"=>"Syndrome"}, {"id"=>"D000017116", "term"=>"Low Back Pain"}], "ancestors"=>[{"id"=>"D000004194", "term"=>"Disease"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000001416", "term"=>"Back Pain"}, {"id"=>"D000010146", "term"=>"Pain"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M4714", "name"=>"Back Pain", "relevance"=>"LOW"}, {"id"=>"M19433", "name"=>"Low Back Pain", "asFound"=>"Lower Back Pain", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-17", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-08", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-09", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To identify Bertolotti's Syndrome-specific kinematic biomarkers using collected patient kinematic and real-time VAS data from range-of-motion tasks.", "timeFrame"=>"2025"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Bertolotti's Syndrome", "Lower Back Pain"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to collect lumbar rotations, velocity, and accelerations, along with pain scores using a novel dynamic VAS device, from twenty (20) Bertolotti Syndrome patients and twenty (20) non-Bertolotti low back pain patients during range-of-motion tasks. The assessments will be analyzed to determine the differences in kinematics and continuous pain scores between Bertolotti patients and non-Bertolotti low back pain patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"20 Bertolotti's Syndrome patients and 20 lower back pain patients", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nLower Back Pain Cohort\n\n* Positive diagnosis of sacroiliac pain or lumbosacral facet arthritis pain\n* Age ≥ 18 years\n\nBertolotti's Syndrome Cohort\n\n* Positive diagnosis of Bertolotti's Syndrome\n* Age ≥ 18 years\n* Positive imaging for Bertolotti's Syndrome\n* Previous analgesic injection results\n\nExclusion Criteria:\n\nLower Back Pain Cohort\n\n* History of spinal deformity, previous spinal surgeries, spinal infections\n* Pregnant women\n\nBertolotti's Syndrome Cohort\n\n* History of spinal deformity, previous spinal surgeries, spinal infections\n* Pregnant women"}, "identificationModule"=>{"nctId"=>"NCT06225583", "briefTitle"=>"Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers", "organization"=>{"class"=>"OTHER", "fullName"=>"The Cleveland Clinic"}, "officialTitle"=>"Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers", "orgStudyIdInfo"=>{"id"=>"IRB 22-1310"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Bertolotti's Syndrome", "description"=>"Subjects with Bertolotti's Syndrome."}, {"label"=>"Non-Bertolotti's Lower Back Pain", "description"=>"Subjects without Bertolotti's Syndrome with lower back pain."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"44195", "city"=>"Cleveland", "state"=>"Ohio", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Michael Steinmetz", "role"=>"CONTACT", "email"=>"steinmm@ccf.org"}], "facility"=>"Cleveland Clinic", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}], "centralContacts"=>[{"name"=>"nya robinson", "role"=>"CONTACT", "email"=>"robinsn8@ccf.org", "phone"=>"216-445-1741"}, {"name"=>"Claudia Tellman", "role"=>"CONTACT", "email"=>"tellmac@ccf.org", "phone"=>"216-444-3026"}], "overallOfficials"=>[{"name"=>"Michael Steinmetz, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"The Cleveland Clinic"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The Cleveland Clinic", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Chairman, Department of Neurosurgery", "investigatorFullName"=>"Michael Steinmetz, MD", "investigatorAffiliation"=>"The Cleveland Clinic"}}}}
