Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT04879394
Status:
UNKNOWN
Last Update Posted:
2022-05-25
First Post:
2021-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2021-05-04', 'studyFirstSubmitQcDate': '2021-05-04', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)', 'timeFrame': '1 week post-intervention', 'description': 'Pain intensity assessed by NRS'}, {'measure': 'Pain intensity at 1 month as assessed by NRS', 'timeFrame': '1 month post-intervention', 'description': 'Pain intensity assessed by NRS'}, {'measure': 'Pain intensity at 3 months as assessed by NRS', 'timeFrame': '3 months post-intervention', 'description': 'Pain intensity assessed by NRS'}, {'measure': 'Pain intensity at 6 months as assessed by NRS', 'timeFrame': '6 months post-intervention', 'description': 'Pain intensity assessed by NRS'}], 'secondaryOutcomes': [{'measure': 'Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI)', 'timeFrame': '1 week post-intervention', 'description': 'Pain interference assessed by the BPI'}, {'measure': 'Pain interference at 1 month as assessed by the BPI', 'timeFrame': '1 month post-intervention', 'description': 'Pain interference assessed by the BPI'}, {'measure': 'Pain interference at 3 months as assessed by the BPI', 'timeFrame': '3 months post-intervention', 'description': 'Pain interference assessed by the BPI'}, {'measure': 'Pain interference at 6 months as assessed by the BPI', 'timeFrame': '6 months post-intervention', 'description': 'Pain interference assessed by the BPI'}, {'measure': 'Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI)', 'timeFrame': '1 week post-intervention', 'description': 'Functionality assessed by the ODI'}, {'measure': 'Functionality at 1 month as assessed by the ODI', 'timeFrame': '1 month post-intervention', 'description': 'Functionality as assessed by the ODI'}, {'measure': 'Functionality at 3 months as assessed by the ODI', 'timeFrame': '3 months post-intervention', 'description': 'Functionality assessed by the ODI'}, {'measure': 'Functionality at 6 months as assessed by the ODI', 'timeFrame': '6 months post-intervention', 'description': 'Functionality assessed by the ODI'}, {'measure': 'Quality of life at 1 week as assessed by the EuroQol Quality of Life Questionnaire (EQ-5D-5L)', 'timeFrame': '1 week post-intervention', 'description': 'Quality of life assessed by the EQ-5D-5L'}, {'measure': 'Quality of life at 1 month as assessed by the EQ-5D-5L', 'timeFrame': '1 month post-intervention', 'description': 'Quality of life assessed by the EQ-5D-5L'}, {'measure': 'Quality of life at 3 months as assessed by the EQ-5D-5L', 'timeFrame': '3 months post-intervention', 'description': 'Quality of life assessed by the EQ-5D-5L'}, {'measure': 'Quality of life at 6 months as assessed by the EQ-5D-5L', 'timeFrame': '6 months post-intervention', 'description': 'Quality of life assessed by the EQ-5D-5L'}, {'measure': 'Emotional distress at 1 week as assessed by the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '1 week post-intervention', 'description': 'Emotional distress assessed by HADS'}, {'measure': 'Emotional distress at 1 month as assessed by the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '1 month post-intervention', 'description': 'Emotional distress assessed by HADS'}, {'measure': 'Emotional distress at 3 months as assessed by the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '3 months post-intervention', 'description': 'Emotional distress assessed by HADS'}, {'measure': 'Emotional distress at 6 months as assessed by the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '6 months post-intervention', 'description': 'Emotional distress assessed by HADS'}, {'measure': 'Optimism at 1 week as assessed by the Life Orientation Test (LOT)', 'timeFrame': '1 week post-intervention', 'description': 'Optimism assessed by LOT'}, {'measure': 'Optimism at 1 month as assessed by LOT', 'timeFrame': '1 month post-intervention', 'description': 'Optimism assessed by LOT'}, {'measure': 'Optimism at 3 months as assessed by LOT', 'timeFrame': '3 months post-intervention', 'description': 'Optimism assessed by LOT'}, {'measure': 'Optimism at 6 months as assessed by LOT', 'timeFrame': '6 months post-intervention', 'description': 'Optimism assessed by LOT'}, {'measure': 'Pain catastrophizing at 1 week as assessed by the Pain Catastrophizing Scale (PCS)', 'timeFrame': '1 week post-intervention', 'description': 'Pain catastrophizing assessed by PCS'}, {'measure': 'Pain catastrophizing at 1 month as assessed by PCS', 'timeFrame': '1 month post-intervention', 'description': 'Pain catastrophizing assessed by PCS'}, {'measure': 'Pain catastrophizing at 3 months as assessed by PCS', 'timeFrame': '3 months post-intervention', 'description': 'Pain catastrophizing assessed by PCS'}, {'measure': 'Pain catastrophizing at 6 months as assessed by PCS', 'timeFrame': '6 months post-intervention', 'description': 'Pain catastrophizing assessed by PCS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to characterize pain sensitivity and psychological profile of CLBP patients in comparison with pain free adults, and explore their predictive role on hypnosis outcomes, an effective intervention for pain control.', 'detailedDescription': 'Chronic low back pain (CLBP) is a very prevalent condition, associated with high disability and financial costs. Pain sensitization and psychological status have been associated with symptom severity and treatment outcomes, but their prognostic value is not yet well established.\n\nThis is a Prospective Randomized Controlled Trial, with an experimental (hypnosis) and one control group (standard care), and 5 assessment points: baseline, post intervention, 1, 3 and 6 months follow-up. Participants will be 160 CLBP patients and 50 pain free adults, assessed on sociodemographic, clinical, pain, disability, psychophysical (Quantitative Sensory Testing) and psychological variables.\n\nThis work will contribute to a better knowledge of the mechanisms underlying CLBP and of the patient characteristics that can predict treatment outcomes after hypnosis. The findings have the potential to improve patient-targeted treatment approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* persistent or recurrent low back pain lasting over 3 months\n\nExclusion Criteria:\n\n* pain due to other causes (e.g. fibromyalgia, fracture)\n* back surgery in the previous 6 months or planned in the following 6 months\n* debilitating organic, psychiatric or neurological conditions (e.g. cancer, schizophrenia, dementia)\n* disability compensation or litigation related to CLBP\n* unavailability to commit to the hypnosis sessions.'}, 'identificationModule': {'nctId': 'NCT04879394', 'briefTitle': 'Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Minho'}, 'officialTitle': 'Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients: Implications for a Personalized Treatment Approach', 'orgStudyIdInfo': {'id': '2CA2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnosis', 'description': '4 weekly hypnosis sessions, aiming at pain control and distress management. The 90 min. sessions will be conducted in group format by a doctorate-level psychologist trained in hypnosis. Contents will be detailed on hypnosis protocols to ensure standardization.', 'interventionNames': ['Other: Hypnosis']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Receives standard care as usual. Assessments will be made in the same time points as experimental group, but without undergoing intervention.'}], 'interventions': [{'name': 'Hypnosis', 'type': 'OTHER', 'description': '4 weekly hypnosis sessions, aiming at pain control and distress management. The 90 min. sessions will be conducted in group format by a doctorate-level psychologist trained in hypnosis. Contents will be detailed on hypnosis protocols to ensure standardization.', 'armGroupLabels': ['Hypnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4710', 'city': 'Braga', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Joana Reis', 'role': 'CONTACT', 'phone': '+351 253 027 249'}], 'facility': 'Hospital de Braga', 'geoPoint': {'lat': 41.5514, 'lon': -8.42311}}], 'centralContacts': [{'name': 'Patrícia R Pinto, PhD', 'role': 'CONTACT', 'email': 'patipinto@gmail.com', 'phone': '00351253604926'}], 'overallOfficials': [{'name': 'Patrícia R Pinto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minho'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minho', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital de Braga', 'class': 'OTHER'}, {'name': 'Clinical Academic Center (2CA-Braga)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Patrícia Ribeiro Pinto', 'investigatorAffiliation': 'University of Minho'}}}}