Nctid:
NCT06224959
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D010003", "term"=>"Osteoarthritis"}, {"id"=>"D008881", "term"=>"Migraine Disorders"}, {"id"=>"D009437", "term"=>"Neuralgia"}], "ancestors"=>[{"id"=>"D001168", "term"=>"Arthritis"}, {"id"=>"D007592", "term"=>"Joint Diseases"}, {"id"=>"D009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D012216", "term"=>"Rheumatic Diseases"}, {"id"=>"D051270", "term"=>"Headache Disorders, Primary"}, {"id"=>"D020773", "term"=>"Headache Disorders"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D010523", "term"=>"Peripheral Nervous System Diseases"}, {"id"=>"D009468", "term"=>"Neuromuscular Diseases"}, {"id"=>"D010146", "term"=>"Pain"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M12926", "name"=>"Osteoarthritis", "asFound"=>"Osteoarthritis", "relevance"=>"HIGH"}, {"id"=>"M12381", "name"=>"Neuralgia", "asFound"=>"Neuropathic Pain", "relevance"=>"HIGH"}, {"id"=>"M11852", "name"=>"Migraine Disorders", "asFound"=>"Migraine", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}, {"id"=>"M9351", "name"=>"Headache", "relevance"=>"LOW"}, {"id"=>"M22529", "name"=>"Headache Disorders", "relevance"=>"LOW"}, {"id"=>"M26657", "name"=>"Headache Disorders, Primary", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M13432", "name"=>"Peripheral Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"T4202", "name"=>"Oculocerebral Syndrome With Hypopigmentation", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>1000}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01-31", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-11", "completionDateStruct"=>{"date"=>"2025-01-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-08", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"the presence of neuropathic pain in patients", "timeFrame"=>"10 minutes", "description"=>"Neuropathic pain is defined by a \"Douleur Neuropathique\" (DN)-4 questionnaire given to the patients, A patient is considered to have characteristics of neuropathic pain if their DN-4 questionnaire score is greater than 4.\n\nDN-4 is a questionnaire used to estimate the likelihood of neuropathic pain in patients and to aid in the diagnosis of neuropathic pain. There are 4 items with a total of 10 questions, the patient must answer yes or no to each question and the doctor counts the answers at the end of the questionnaire, 1 for a yes answer and 0 for a no answer, and the sum obtained is the patient's score."}, {"measure"=>"the presence of migraine in patients", "timeFrame"=>"10 minutes", "description"=>"Completing the headache questionnaire of the International Headache Society (IHS). Strict migraine is defined as meeting all the criteria for migraine as defined by the IHS. Probable migraine sufferers are those who meet all but one of the migraine criteria.\n\nIHS criteria is defined by :\n\nA. At least five seizures meeting criteria B through D.\n\nB. Headache attacks lasting 4 to 72 hours (without treatment).\n\nC. Headache with at least two of the following features : One-sided; pulsating; moderate or severe; worsened by routine physical activities, such as climbing or descending stairs\n\nD. At least one of the following during the headache :nausea and/or vomiting; photophobia and phonophobia.\n\nE. Clinical examination should be normal between attacks. In case of doubt, an organic disorder must be excluded by appropriate additional investigations."}], "secondaryOutcomes"=>[{"measure"=>"the presence of anxiety and depression symptoms in patients", "timeFrame"=>"10 minutes", "description"=>"to evaluate the impact of migraine or/and neuropathic pain in patients with osteoarthritis on anxiety and depression symptoms by the Hospital Anxiety and Depression scale questionnaire (HADs). The HADs questionnaire have 14 items, each item is rated on a scale of 0 to 3, with higher scores associated with the presence and level of symptoms."}, {"measure"=>"measure the level of catastrophizing thoughts related to pain in patients", "timeFrame"=>"10 minutes", "description"=>"to assess how patients with osteoarthritis perceive and react to pain emotionally because of their migraine or/and neuropathic pain by the Pain Catastrophizing Scale (PCS) questionnaire. The questionnaire have 13 items that assess 3 components of catastrophization pain : exaggeration, rumination and helplessness."}, {"measure"=>"Impact of headhache in patients", "timeFrame"=>"10 minutes", "description"=>"Headache patients complete the Headache Impact Test (HIT-6), which measures the impact of headaches on daily life. It's a 6-question questionnaire with a choice of 5 answers, with points ranging from 6 to 13 per answer. The scores for each column of each question are added together. The higher the score, the greater the impact of the headache on daily life. Scores range from 36 to 78."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["osteoarthritis", "migraine", "neuropathic pain"], "conditions"=>["Osteoarthritis", "Migraine", "Neuropathic Pain"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to estimate the frequency of neuropathic pain and migraines in a group of patients with osteoarthritis of the knees, hips, hands, spine or other joints. In addition to their usual care for osteoarthritis, participants will complete questionnaires to define migraine and neuropathic pain.", "detailedDescription"=>"This study will be proposed to patients with osteoarthritis who come for their routine consultation. If the patient has no abjection to taking part in the study, the doctor will give them the questionnaires to fill in. The questionnaires are about: perception of pain , depression and anxiety, how patients manage their disease emotionally, migraine, neuropathic pain, functional ability, osteoarthritis assessment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Patients diagnosed with articular and/or spinal osteoarthritis, under the care of the University Hospital of Clermont-Ferrand (Rheumatology, Physical Medicine and Rehabilitation, Sports Medicine, Occupational Health and Environment, Orthopedics), and/or managed by specialized professionals (general practitioners, sports physicians, rheumatologists, rehabilitation specialists, orthopedic surgeons) in private medical practice", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* patients over 18 years old\n* patients with articular or/and spinal osteoarthritis\n* affiliation to a social security system.\n* able to read and understand french\n\nExclusion Criteria:\n\n* patients who refuse to participate in the study\n* patients unable to complete self-questionnaires\n* minors or adults under the protection of the law or under the protection of justice"}, "identificationModule"=>{"nctId"=>"NCT06224959", "acronym"=>"MEDUSA", "briefTitle"=>"Migraine and Neuropathic Pain in Osteoarthritis", "organization"=>{"class"=>"OTHER", "fullName"=>"University Hospital, Clermont-Ferrand"}, "officialTitle"=>"Prevalence of Migraine and Neuropathic Pain in Osteoarthritis: Multicenter, Multidisciplinary, Cross-sectional Epidemiological Study.", "orgStudyIdInfo"=>{"id"=>"RNI 2023 MATHIEU"}, "secondaryIdInfos"=>[{"id"=>"2023-A00093-42", "type"=>"OTHER", "domain"=>"ANSM"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Clermont-Ferrand", "country"=>"France", "facility"=>"CHU Clermont-Ferrand", "geoPoint"=>{"lat"=>45.77966, "lon"=>3.08628}}], "centralContacts"=>[{"name"=>"Lise Laclautre", "role"=>"CONTACT", "email"=>"promo_interne_drci@chu-clermontferrand.fr", "phone"=>"334.73.754.963"}], "overallOfficials"=>[{"name"=>"Sylvain MATHIEU", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University Hospital, Clermont-Ferrand"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University Hospital, Clermont-Ferrand", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
