Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
Study NCT ID:
NCT03058003
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2017-02-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Central Sensitization Inventory and Posturographic Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D051298', 'term': 'Post-Traumatic Headache'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], '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': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stability Score', 'timeFrame': 'immediately after data collection', 'description': 'The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups'}, {'measure': 'CSI', 'timeFrame': 'immediately after data collection', 'description': 'The sum of all the answers to the Central Sensitization Inventory will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups'}], 'secondaryOutcomes': [{'measure': 'CSI-SS', 'timeFrame': 'immediately after data collection', 'description': 'Correlation between the Stability Score and the CSI result for each individual to determine if balance is an indicator of Central Nervous System Sensitization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['balance, postural', 'postural equilibrium', 'chronic pain', 'Chronic nonspecific low back pain', 'Fibromyalgia', 'Cervicogenic headache', 'Chronic tension type headache', 'Irritable bowel syndrome', 'Whiplash associated disorder', 'Temporomandibular disorder'], 'conditions': ['Central Nervous System Sensitization']}, 'descriptionModule': {'briefSummary': 'To investigate the use of balance as a screening tool for Central Sensitization, a condition of the nervous system that is associated with the development and maintenance of chronic pain. This is done by comparing the scores of a gold standard screening tool (the Central Sensitization Inventory) with balance data.', 'detailedDescription': 'First, subjects will be asked to answer a brief medical questionnaire pertaining their general health status: since some of the subjects will be self-assessed to be "healthy" (no medical examination will be conducted to determine if this is indeed the case), the questionnaire will be used to determine if there are any possible known causes of poor balance performance. The questionnaire will not constitute an inclusion/exclusion criterion, it just has a classification purpose.\n\nSubjects will then be asked to fill in the Central Sensitization Inventory (CSI), scoring each of the 25 items on a scale from 0 (never) to 4 (always).\n\nThen, subjects will stand for 2 minutes on a compliant surface (a 4" tall foam cushion of known mechanical properties) to "learn" how to stand on it. Afterward, they will undergo posturography testing using the extended modified Clinical Testing of Sensory Integration in Balance (ext\\_mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the side and free to move, gazing forward, and breathing normally, with head straight, turned right or left, flexed or extended.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults, self assess to be in good health or diagnosed with Central Nervous System Sensitization', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, self assessed to be in good health, or medically diagnosed with any of the following pathologies: Chronic nonspecific low back pain (CNSLBP), Fibromyalgia (FM), Cervicogenic Headche (CH), Chronic Tension Type Headache (CTT), Irritable Bowel Syndrome (IBS), Whiplash Associated Disorder (WAD), Temporomandibular Disorder (TMD)\n\nExclusion Criteria:\n\n* Pregnant women will be excluded, as will be minors'}, 'identificationModule': {'nctId': 'NCT03058003', 'briefTitle': 'Correlation Between Central Sensitization Inventory and Posturographic Data', 'organization': {'class': 'OTHER', 'fullName': 'Caps Research Network'}, 'officialTitle': 'Correlation Between Central Sensitization Inventory and Posturographic Data', 'orgStudyIdInfo': {'id': 'CI-IRB-20170124001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'subjects suffering from chronic pain undergoing Posturography Evaluation and Central Sensitization Inventory', 'interventionNames': ['Diagnostic Test: Posturography Evaluation', 'Other: Central Sensitization Inventory']}, {'label': 'Healthy', 'description': 'subjects self assessed to be in good health undergoing Posturography Evaluation and Central Sensitization Inventory', 'interventionNames': ['Diagnostic Test: Posturography Evaluation', 'Other: Central Sensitization Inventory']}], 'interventions': [{'name': 'Posturography Evaluation', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Balance Testing', 'CAPS® Testing'], 'description': 'Posturography testing using the extended modified Clinical Testing of Sensory Integration in Balance (ext\\_mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the side and free to move, gazing forward, and breathing normally, with head straight, turned right or left, flexed or extended', 'armGroupLabels': ['Healthy', 'Patients']}, {'name': 'Central Sensitization Inventory', 'type': 'OTHER', 'description': 'Standard chronic pain questionnaire: the subjects will be required to score each of the 25 items on a scale from 0 (never) to 4 (always)', 'armGroupLabels': ['Healthy', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30062', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Innova Brain Rehabilitation', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '3188', 'city': 'Hampton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Small Street Clinic', 'geoPoint': {'lat': -37.95, 'lon': 145.0}}], 'overallOfficials': [{'name': 'Paul Noone, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Caps Research Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caps Research Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}