Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05592405
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2022-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 103}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Demograpics', 'timeFrame': '12 weeks', 'description': 'established prognostic factors for low back pain'}], 'primaryOutcomes': [{'measure': 'Central sensitiszation QST', 'timeFrame': '12 weeks follow-up', 'description': 'Quantitative sensory testing'}, {'measure': 'Central senzitization CSI', 'timeFrame': '12 weeks follow-up', 'description': 'Central sensitization inventory'}, {'measure': 'Central sensitization PSQ', 'timeFrame': '12 weeks follow-up', 'description': 'Pain sensitization questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Sensitisation', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Assessing associations between Sensory profiles and nociplastic pain symptoms, and assessing the prognostic value of sensory profiles in the development of nociplastic pain symptoms in a low back pain population.', 'detailedDescription': 'Therefore, the investigators aims are:\n\n* The primary aim of the study is to assess associations between Sensory Profiles (Adolescent/Adult Sensory Profiles) and Nociplastic pain Symptoms, in the acute and chronic low back pain population.\n* The secondary aim is to assess the prognostic value of sensory profiles in the transition to central sensitisation and pain, in the acute and chronic low back pain population at twelve weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Evaluation of eligibility will take place during assessment when the participant reports in primary care physiotherapy practice for the treatment of LBP.\n\nPatients will be included consecutively and measurements will be obtained by the investigator.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with non-specific LBP\n* with or without radiating pain\n* aged 18-65 years\n* able to read and understand the Dutch language\n\nExclusion Criteria:\n\n* previous lumbar spinal surgery\n* radiculopathy or any specific cause of low back pain such as lumbar spinal stenosis, current malignancy, spondyloarthropathy, osteoporosis, spondylolisthesis, major trauma, infection, or systemic disease.'}, 'identificationModule': {'nctId': 'NCT05592405', 'briefTitle': 'Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'Nociplastic Pain Measurement and Sensory Profiles in Patients with Acute and Chronic Low Back Pain: a Longitudinal Observational Cohort Study', 'orgStudyIdInfo': {'id': 'QST_SPs'}}, 'contactsLocationsModule': {'locations': [{'city': 'Zwolle', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Fysiomobilae', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Aldo Scafoglieri, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vrije Universiteit Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sharing is unlikely as the data set includes pseudo-anominizised highly confidential data, of which the participants do not gave their consent to use their provided data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Pieter Graper', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}