Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT05097235
Status:
COMPLETED
Last Update Posted:
2023-06-13
First Post:
2021-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in Low Back Pain Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098653', 'term': 'Nociplastic Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-11', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Sensitization Inventory', 'timeFrame': '12 weeks', 'description': "Central Sensitization Inventory (CSI) is a questionnaire which consists of 2 parts. Part A measures 25 symptoms on a 5-point scale, scoring ranges from 0-4, with a total on an ordinal scale ranging from 0-100. Part B records the presence diagnosed central sensitization syndromes, on a nominal scale. Four factors with excellent internal consistency (Cronbach's alpha= 0.91) can be identified: disability and physical symptoms; higher central sensitivity; urological and dermatological symptoms and emotional distress. The CSI has an excellent test-retest reliability of ICC=0.88 in chronic low back pain populations."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sensory profiles, central sensitization, low back pain.'], 'conditions': ['Sensory Profiles, Nociplastic Pain, Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study conducts prognostic research to develop, validate, and evaluate the predictive role of sensory profiles in the development of sensory profiles over time. Therefore, a type 3 prognostic model research will be conducted in the low back pain population.', 'detailedDescription': 'This is a longitudinal multi-centre prospective cohort study design with two measurements.The STROBE statement is used as guideline and the results are reported according to the TRIPOD, and REMARK checklists. The study is a type III prognostic model research study, following the PROGRESS framework to assess the outcome by the development, validation, and evaluation of the impact of incorporating single or multiple prognostic factors, and their prognostic value at baseline in the development of CS over a period of 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '-primary physiotherapy practices in the Netherlands.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with acute LBP (\\< six weeks)\n* with or without radiating pain\n* aged 18 to 60 years\n* a pain-free episode for at least 12 weeks before the onset of their current back pain.\n* be able to read and understand the Dutch language.\n\nExclusion Criteria:\n\n* any specific cause of low back pain'}, 'identificationModule': {'nctId': 'NCT05097235', 'acronym': 'T3PredCohSt', 'briefTitle': 'Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in Low Back Pain Population.', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'Type III PROGRESS Framework for Prognosis Research: Building Prognostic Models for Sensory Profiles in the Development of Central Sensitisation in the Chronic Low Back Pain Population', 'orgStudyIdInfo': {'id': 'T-3LoCoSt'}}, 'armsInterventionsModule': {'armGroups': [{'label': 't0, t1', 'description': 'acute low back pain, inclusion criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8014XE', 'city': 'Zwolle', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Fysiomobilae', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Aldo Scafoglieri, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vrije Universiteit Brussel, Brussels, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pieter Graper', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}