Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-31 @ 11:13 AM
Study NCT ID:
NCT05062694
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Therapy Management Of The Patient With Central Sensitization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Physical therapists' patient management", 'timeFrame': '1 month', 'description': "Exploring Italian physiotherapists' clinical approach to the patient in question through an online survey"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient Management', 'Central Sensitisation', 'Muscoloskeletal Disease', 'Pain'], 'conditions': ['Central Sensitisation', 'Musculoskeletal Diseases', 'Pain']}, 'referencesModule': {'references': [{'pmid': '37143408', 'type': 'DERIVED', 'citation': 'Baroni A, Margelli M, Saoncella A, Toigo I, Antonellini G, Straudi S. Physiotherapy management of nociplastic pain: A Delphi study of Italian specialists. Pain Pract. 2023 Sep;23(7):734-742. doi: 10.1111/papr.13238. Epub 2023 May 4.'}]}, 'descriptionModule': {'briefSummary': 'In the literature there is still debate about the concept of central sensitization, as a pain mechanism that can support a neuromusculoskeletal pathology and which for Woolf corresponds to an amplification of neural signaling within the Central Nervous System causing hypersensitivity to pain.\n\nThis mechanism is often confused with the concept of chronic pain, as in many conditions such as fibromyalgia, traumatic neck pain, low back pain or osteoarthritis, central sensitization supports its maintenance beyond 6 months.\n\nWe believe it is important to investigate among Italian physiotherapists the management of the patient in which the presence of a central pain sensitization phenomenon is suspected, in order to provide consistent data to direct the education of health professionals towards more effective management of this problem.\n\nTo achieve this goal we aim to:\n\n* Conduct a Delphi study in order to reach consensus, into a panel of experts, on the methods useful for the management, in each phase of the physiotherapy process, of the patient with neuromusculoskeletal problems with pain underlying central sensitization mechanism\n* Investigate, through a survey among Italian physiotherapists, their clinical approach to the patient in question\n* Develop a free online course available to clinical professionals and/or students who wish to deepen this issue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Physical therapists', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Italian physiotherapists who will decide to fill in the questionnaire\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT05062694', 'briefTitle': 'Physical Therapy Management Of The Patient With Central Sensitization', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Physical Therapy Management Of The Patient With Central Sensitization: An Observational Study Among Italian Physiotherapists', 'orgStudyIdInfo': {'id': 'Survey_CS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'It will be created a questionnaire to investigate, among Italian physiotherapists, their clinical approach to the patient with Central Sensitisation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Ferrara', 'state': 'FE', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sofia Straudi', 'investigatorAffiliation': 'University Hospital of Ferrara'}}}}