Nctid:
NCT06611722
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "relevance"=>"LOW"}, {"id"=>"M4324", "name"=>"Anxiety Disorders", "relevance"=>"LOW"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "asFound"=>"Psychological Disorders", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T4202", "name"=>"Oculocerebral Syndrome With Hypopigmentation", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>70}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2023-12-05", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-22", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"the Beck Depression Inventory (BDI)", "timeFrame"=>"5 minutes", "description"=>"The BDI is a self-assessment scale that has been demonstrated to be a reliable and valid tool for evaluating depressive symptoms. The BDI comprises 21 items, each item is assigned a score on a scale of 0 to 3, with higher scores indicating a greater severity of depressive symptoms."}, {"measure"=>"the Zung Self-Rating Anxiety Scale (SAS)", "timeFrame"=>"5 minutes", "description"=>"The SAS is a self-assessment instrument designed to evaluate the presence and severity of anxiety symptoms. The SAS consists of 20 items, each item consisting of four statements, and each item is scored on a scale of 1 to 4. A higher score indicates a higher level of anxiety."}], "secondaryOutcomes"=>[{"measure"=>"the Visual Analogue Scale (VAS)", "timeFrame"=>"2 minutes", "description"=>"for the assessment of the level of hip pain perceived by the patient"}, {"measure"=>"the Pain Sensitivity Questionnaire (PSQ)", "timeFrame"=>"5 minutes", "description"=>"for the assessment of the individual's sensitivity to pain"}, {"measure"=>"The Hip Outcome Score Activities of Daily Living (HOS-ADL)", "timeFrame"=>"5 minutes", "description"=>"evaluate the functional activities necessitated by daily life with the hip"}, {"measure"=>"The Hip Outcome Score - Sport-specific subscale (HOS-SSS)", "timeFrame"=>"5 minutes", "description"=>"assess the capacity to perform sports activities"}, {"measure"=>"the modified Harris Hip Score (mHHS)", "timeFrame"=>"5 minutes", "description"=>"assess the functional level of the hip joint"}, {"measure"=>"the international hip outcome tool (IHOT-12)", "timeFrame"=>"5 minutes", "description"=>"assess the functional level of the hip joint"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["hip", "pain", "Psychological Disorders", "depression", "anxiety"], "conditions"=>["Psychological Disorders", "Hip Pain Chronic"]}, "descriptionModule"=>{"briefSummary"=>"Nowadays, studies related to the psychological state of patients with chronic hip pain are still limited, and there is a lack of research on the characteristics of the psychological state of patients with chronic soreness from different pain sources. The goal of this retrospective cross-sectional study was to reveal differences between the psychological states of chronic hip pain patients with different pain sources. The main question it aims to answer is whether there are differences in psychological states among hip pain patients with intra-hip pain, extra-hip pain, and intra-hip combined with extra-hip pain."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"16 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with chronic hip pain who visited the hip joint specialist outpatient clinic of the PLA General Hospital were included in the study. The diagnosis was made by the same docter based on clinical and radiological examinations, with a clear diagnosis of hip disease. Patients were divided into three groups according to the source of pain: intra-articular pain group, extra-articular pain group, and intra-articular combined extra-articular pain group. Intra-articular hip pain encompasses a range of conditions, including femoral acetabular impingement (FAI) and labral damage within the hip joint. Extra-articular hip pain encompasses conditions such as trochanteric bursitis and gluteal fasciitis. Combined hip pain represents a combination of both of these etiological factors.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* The subject must be at least 16 years old and of sound mind；\n* Chronic hip pain persisting for a duration exceeding 3 months.\n\nExclusion Criteria:\n\n* Previous mental illness and cognitive impairment；\n* Other serious illnesses such as heart failure, respiratory failure, malignant tumours, severe trauma and other serious illnesses;；\n* Chronic pain lasting for more than 3 months in other parts of the body;；\n* Use of prescribed opioid drugs exceeding 60 mg morphine equivalent per day or steroid analgesics."}, "identificationModule"=>{"nctId"=>"NCT06611722", "briefTitle"=>"The Differences in the Psychological States of Patients with Different Chronic Hip Pain", "organization"=>{"class"=>"OTHER", "fullName"=>"Chinese PLA General Hospital"}, "officialTitle"=>"A Clinical Retrospective Cross-sectional Study of the Differences in the Psychological States of Patients with Different Chronic Hip Pain", "orgStudyIdInfo"=>{"id"=>"2023KY031-KS001"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"intra-articular hip pain group", "interventionNames"=>["Other: Psychological and Functional Assessment"]}, {"label"=>"extra-articular hip pain group", "interventionNames"=>["Other: Psychological and Functional Assessment"]}, {"label"=>"intra-articular combined extra-articular hip pain group", "interventionNames"=>["Other: Psychological and Functional Assessment"]}], "interventions"=>[{"name"=>"Psychological and Functional Assessment", "type"=>"OTHER", "description"=>"Assessment of Pain Sources: Patients are grouped based on intra-articular, extra-articular, or combined intra- and extra-articular hip pain.Psychological Assessment: Depression and anxiety are assessed using standardized questionnaires (e.g., BDI for depression, SAS for anxiety).Functional Assessment: Joint function and pain are evaluated using clinical and patient-reported outcome measures.", "armGroupLabels"=>["extra-articular hip pain group", "intra-articular combined extra-articular hip pain group", "intra-articular hip pain group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100000", "city"=>"Beijing", "state"=>"Beijing", "country"=>"China", "facility"=>"General Hospital of the Chinese People's Liberation Army", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}], "overallOfficials"=>[{"name"=>"Chunbao Li", "role"=>"STUDY_DIRECTOR", "affiliation"=>"The Fourth Medical Centre of the General Hospital of the People's Liberation Army"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"ChunBao Li", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"deputy chief physician", "investigatorFullName"=>"ChunBao Li", "investigatorAffiliation"=>"Chinese PLA General Hospital"}}}}
