Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT05994118
Status:
UNKNOWN
Last Update Posted:
2023-08-16
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subcutaneous injection of Saline solution (NACL 0.9%) in the buttock'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-15', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2023-08-15', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain modulation - Temporal Summation', 'timeFrame': 'Once, at baseline', 'description': 'Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to the first and last electrical noxious stimuli'}, {'measure': 'Pain modulation - Conditioned pain modulation', 'timeFrame': 'Once, at baseline', 'description': 'Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to concurrent noxious stimuli'}, {'measure': 'Biological markers - cortisol', 'timeFrame': '1 day (Before and after administration of saline)', 'description': 'Saliva cortisol levels'}, {'measure': 'Biological markers - secretory IgA', 'timeFrame': '1 day (Before and after administration of saline)', 'description': 'Saliva secretory IgA level'}, {'measure': 'Biological markers - oxytocin', 'timeFrame': '1 day (Before and after administration of saline)', 'description': 'Saliva oxytocin level'}, {'measure': 'Autonomic measures - Heart rate variability', 'timeFrame': '1 day (Before and after administration of saline)', 'description': 'As measured by a monitor'}, {'measure': 'Autonomic measures - blood pressure', 'timeFrame': '1 day (Before and after administration of saline)', 'description': 'As measured by a monitor'}, {'measure': 'Short-term memory', 'timeFrame': 'Once, at baseline', 'description': 'via the Digit Span test'}, {'measure': 'Pain sensitivity via QST', 'timeFrame': '1 day (Before and after administration of saline)', 'description': 'Mechanical pain thresholds'}, {'measure': 'Questionnaire - Optimism', 'timeFrame': 'Once, at baseline', 'description': 'Via the life orientation test revised (LOT-R)'}, {'measure': 'Questionnaire - pain sensitivity', 'timeFrame': 'Once, at baseline', 'description': 'Via the pain sensitivity questionnaire (PSQ)'}, {'measure': 'Questionnaire - interoceptive awareness', 'timeFrame': 'Once, at baseline', 'description': 'Via the Multidimensional assessment of interoceptive awareness (MAIA questionnaire)'}, {'measure': 'Questionnaire - direction of attention', 'timeFrame': 'Once, at baseline', 'description': 'Via the Self consciousness scale revised'}, {'measure': 'Questionnaire Body awareness', 'timeFrame': 'Once, at baseline', 'description': 'via the body awareness Questionnaire (BAQ)'}, {'measure': 'Questionnaire - suggestibility', 'timeFrame': 'Once, at baseline', 'description': 'Via the short suggestibility scale (SSS)'}, {'measure': 'Questionnaire - expectations', 'timeFrame': 'Once, at baseline', 'description': 'via the expect Questionnaire'}, {'measure': 'Questionnaire - perceived stress', 'timeFrame': 'Once, at baseline', 'description': 'via the perceived stress scale'}], 'primaryOutcomes': [{'measure': 'Reduction of pain following placebo injection', 'timeFrame': 'Half an hour after injection', 'description': 'The reduction in pain intensity on the 0-100 numerical rating scale (NRS) after normal saline injection'}, {'measure': 'Within-subjects variability of day-to-day clinical pain reports', 'timeFrame': '7 days before study visit', 'description': 'The variance of within person pain scores reported on a 0-100 Visual Analog Scale VAS during 7 days via pain-dairy at baseline'}], 'secondaryOutcomes': [{'measure': 'The Focused Analgesia selection task (FAST)', 'timeFrame': 'Once, at baseline', 'description': 'Experimental paradigm which allow calculation of within-subjects variability of pain reports in response to thermal stimuli'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Back Pain']}, 'descriptionModule': {'briefSummary': "This study attempt to identify whether and how factors known or considered to be related with analgesic placebo effect or variability of pain reports separately, may contribute to their coupling. Among these factors - personal traits such as optimism, focus of attention, suggestibility, and short-term memory along with characteristics of stress and relaxation. Additionally, the role of pain sensitivity and the individual's pain modulation profile in the relationship between analgesic placebo effect and variability of pain reports will be examined.", 'detailedDescription': 'Data will be collected from 130 patients with non-specific chronic back pain that will be recruited for a prospective cross-sectional study. To characterize the main study variables, the participants will undergo the Focused analgesia selection test (FAST) which evaluates within-subjects variability of pain reports, and placebo manipulation containing administration of an inert injection accompanied by a verbal suggestion, which is expected to produce placebo effects. The involvement of additional factors considered associated with the within-subjects variability of pain reports and the placebo response will be explored. Stress and well-being characteristics will be examined by measuring cortisol levels in saliva and in hair, salivary level of Secretory Immune globulin A (SIgA), and an autonomic nervous system function and a stress perception questionnaire. Personal traits such as suggestibility, optimism, and Focus of attention, will be examined using questionnaires. Memory will be assessed by memory task, and factors related to the pain modulation system will be examined using psychophysical tests, and a pain sensitivity questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Literate adults\n* Aged 18 - 80 years\n* A diagnosis of chronic back pain\n* Sufferings from back pain during the last 3 months or more, with an intensity of 3 or more on a 0-10 NRS\n\nExclusion Criteria:\n\n* Mental retardation or cognitive impairment\n* Pregnancy or breast-feeding\n* Malignancy and a diagnosis of malignant disease'}, 'identificationModule': {'nctId': 'NCT05994118', 'briefTitle': 'Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': 'Exploring the Role of Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports', 'orgStudyIdInfo': {'id': '0044-20-NHR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': '0.5 milliliter of NACL 0.9% subcutaneous saline injection', 'interventionNames': ['Other: NaCl 0.9% (normal saline)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Magnetized Normal Saline', 'description': '0.5 milliliter of magnetized NACL 0.9% subcutaneous saline injection', 'interventionNames': ['Other: Magnetized Normal Saline']}], 'interventions': [{'name': 'NaCl 0.9% (normal saline)', 'type': 'OTHER', 'description': 'Subcutaneous normal saline injection', 'armGroupLabels': ['Normal Saline']}, {'name': 'Magnetized Normal Saline', 'type': 'OTHER', 'description': 'Magnetized Normal Saline', 'armGroupLabels': ['Magnetized Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2210001', 'city': 'Nahariya', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Adi Shani, MA', 'role': 'CONTACT', 'email': 'a.eilat888@gmail.com', 'phone': '+972-524239112'}], 'facility': 'Galilee Medical center', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}], 'centralContacts': [{'name': 'Roi Treister, PhD', 'role': 'CONTACT', 'email': 'rtreister@univ.haifa.ac.il', 'phone': '0533839935'}], 'overallOfficials': [{'name': 'Roi Treister, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Haifa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Once published, the data (without any personal identification) will be available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Haifa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}