Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-03-30 @ 6:39 PM
Study NCT ID:
NCT05869695
Status:
UNKNOWN
Last Update Posted:
2023-05-22
First Post:
2023-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcultural Adaptation and Validation to Spanish of the OSPRO Questionnaires
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073222', 'term': 'Patient Health Questionnaire'}], 'ancestors': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2023-05-05', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-Reported Outcome Measure (PROM) development: Translation and Cross Cultural Adaptation to the Spanish population of the Optimal Screening for Prediction of Referral and Outcome (OSPRO) questionnaires.', 'timeFrame': 'from September 2018 to July 2021', 'description': 'Two native Spanish speakers, health experienced in musculoskeletal pain and knowledge of English, translated into Spanish the Optimal Screening for Prediction of Referral and Outcome-Review of Systems (OSPRO-ROS) questionnaire original (English) and the Optimal Screening for Prediction of Referral and Outcome Yellow-Flags (OSPRO-YF) original questionnaire (English).\n\nTwo native English speakers, knowledge of Spanish, reverse-translate the text to Spanish.\n\n25 participants with musculoskeletal pain completed the Optimal Screening for Prediction of Referral and Outcome (OSPRO) questionnaires.\n\nThis outcome will be evaluated according the Consensus-based Standards for the selections of health Measurement Instruments (COSMIN) Risk of Bias checklist for PROMs, using their scoring manual: very good/adequate/doubtful/inadequate/NA for each standar.'}], 'secondaryOutcomes': [{'measure': 'OSPRO questionnaires Psychometric property Validation', 'timeFrame': 'from January to June 2024', 'description': 'The validity and reliability of the Spanish version translated from the questionnaires Optimal Screening for Prediction of Referral and Outcome (OSPRO) will be assessed.\n\nThis outcome will be evaluated according the Consensus-based Standards for the selections of health Measurement Instruments (COSMIN) Risk of Bias checklist for PROMs, using their scoring manual: very good/adequate/doubtful/inadequate/NA for each standar.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OSPRO', 'Review of Systems', 'Red Flags', 'Psychosocial factors', 'Yellow Flags', 'Cross-cultural', 'Reliability', 'Validity'], 'conditions': ['Musculoskeletal Pain']}, 'descriptionModule': {'briefSummary': 'Clinical guidelines for managing musculoskeletal pain recommend first, assessing and identifying any signs of severe physical conditions (i.e."red flags") and then, asessing the psychosocial prognostic factors of poor outcomes (i.e."yellow flags"). The Optimal Sreening for Prediction of Referral and Outcome (OSPRO) cohort studies were designed to develop and validate standard assessment tools for Review Of Systems (OSPRO-ROS) and Yellow Flags (OSPRO-YF).', 'detailedDescription': 'The objectives of this study were to translate and cross-cultural adapt OSPRO-ROS and OSPRO-YF questionnaires to Spanish and to investigate their psychometric properties for their use in subjects with musculoskeletal pain.To accomplish the objectives proposed, this study was developed in two phases:Phase I: Cross-cultural adaptation process.Phase II: Psychometric properties evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'OSPRO-ROS:\n\nPerson between 18 and 75 years of age who goes to the emergency department, presenting acute musculoskeletal pain with primary complaints involving the cervical spine, lumbar spine, shoulder or knee.\n\nOSPRO-YF:\n\nPerson between 18 and 75 years of age who goes to the rehabilitation department, presenting chronic musculoskeletal pain with primary complaints involving the cervical spine, lumbar spine, shoulder or knee.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOSPRO-ROS:\n\n1. Were coming to the emergency department on their first visit.\n2. With acute musculoskeletal pain.\n3. Were able to read and comprehed Spanish language.\n\nOSPRO-YF:\n\n1. Were seeking outpatient physical therapy treatment.\n2. With chronic musculoskeletal pain involving the cervical spine, lumbar spine, shoulder or knee.\n3. Were able to read and comprehend Spanish language.\n\nExclusion Criteria:\n\n1. Widespread chronic pain syndrome (e.g. fibromyalgia or irritable bowel syndrome).\n2. Neuropathic pain syndrome (e.g. complex regional pain syndrome or diabetic neuropathy).\n3. Psychiatric history (currently in care of mental health care provider or taking \\> 2 precription psychiatric medications)\n4. Cancer (currently receiving treatment for active cancer)\n5. Neurological disorder (e.g. stroke, spinal cord injury, or traumatic brain injury).'}, 'identificationModule': {'nctId': 'NCT05869695', 'acronym': 'SpanishOSPRO', 'briefTitle': 'Transcultural Adaptation and Validation to Spanish of the OSPRO Questionnaires', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Transcultural Adaptation and Validation to Spanish of the Optimal Screening for Prediction of Referral and Outcome (OSPRO) Questionnaires for Review-Of-Systems (OSPRO-ROS) and Yellow-Flags (OSPRO-YF) in Subjects With Musculoskeletal Pain.', 'orgStudyIdInfo': {'id': '102999'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSPRO-ROS: 100 patients presenting musculoskeletal pain', 'description': 'Patients between 18 and 75 years of age with primary complaints involving the cervical spine, lumbar spine, shoulder or knee. Were able to read and comprehend Spanish.', 'interventionNames': ['Other: OSPRO-ROS Questionnaire']}, {'label': 'OSPRO-YF: 100 patients presenting musculoskeletal pain', 'description': 'Patients between 18 and 75 years of age with primary complaints involving the cervical spine, lumbar spine, shoulder or knee. Were able to read and comprehend Spanish.', 'interventionNames': ['Other: OSPRO-YF Questionnaire']}], 'interventions': [{'name': 'OSPRO-ROS Questionnaire', 'type': 'OTHER', 'otherNames': ['Result of complementary tests', 'OSPRO-ROS retest'], 'description': 'Completion of questionnaires', 'armGroupLabels': ['OSPRO-ROS: 100 patients presenting musculoskeletal pain']}, {'name': 'OSPRO-YF Questionnaire', 'type': 'OTHER', 'otherNames': ['Chronic Pain Acceptance Questionnaire (CPAQ)', 'Fear-Avoidance Beliefs Questionnaire (FABQ)', 'Pain Catastrophizing Scale (PCS)', 'Patient Health Questionnaire-9 (PHQ-9)', 'State Trait Anxiety Inventory (STAI)', 'Tampa Scale for Kinesiophobia-11 (TSK-11)', 'OSPRO-YF retest'], 'description': 'Completion of questionnaires', 'armGroupLabels': ['OSPRO-YF: 100 patients presenting musculoskeletal pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08174', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'MANUEL TORELLÓ VILAR', 'role': 'CONTACT', 'email': 'mtorellovilar@asepeyo.es', 'phone': '+34935653900'}, {'name': 'MELÀNIA MASÓ NÚÑEZ', 'role': 'CONTACT', 'email': 'melania.maso@eug.es', 'phone': '+34935893727', 'phoneExt': '218'}], 'facility': 'Hospital Asepeyo Sant Cugat', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}, {'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'MARTA TELLO FONTANET', 'role': 'CONTACT', 'email': 'MTello@CST.cat', 'phone': '+34937003608', 'phoneExt': '2025'}, {'name': 'MELÀNIA MASÓ NÚÑEZ', 'role': 'CONTACT', 'email': 'melania.maso@eug.es', 'phone': '+34935893727', 'phoneExt': '219'}], 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'centralContacts': [{'name': 'MELÀNIA MASÓ NÚÑEZ', 'role': 'CONTACT', 'email': 'melania.maso@eug.es', 'phone': '+34935893727', 'phoneExt': '219'}, {'name': 'MARTA TELLO FONTANET', 'role': 'CONTACT', 'email': 'MTello@CST.cat', 'phone': '+34937003608', 'phoneExt': '2025'}], 'overallOfficials': [{'name': 'ENRIQUE LLUCH GIRBÉS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNIVERSITAT DE VALÈNCIA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alcala', 'class': 'OTHER'}, {'name': 'Escoles Universitaries Gimbernat', 'class': 'OTHER'}, {'name': 'Hospital ASEPEYO Sant Cugat', 'class': 'UNKNOWN'}, {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Enrique Lluch Girbés', 'investigatorAffiliation': 'University of Valencia'}}}}