Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-04-20 @ 12:00 AM
Study NCT ID:
NCT03376269
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2015-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2015-04-06', 'studyFirstSubmitQcDate': '2017-12-13', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain sensitivity', 'timeFrame': 'Change After 3 months', 'description': 'Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)'}, {'measure': 'Brain microstructure', 'timeFrame': 'Change after 3 months', 'description': 'MRI dynamic tensor imaging sequence will be performed (DTI). Fractional anisotropy (FA) values will be assessed at base line and at 3 months. The changes at 3 months from baseline will be compared'}, {'measure': 'Brain Metabolism', 'timeFrame': 'Change after 3 months', 'description': 'Brain metabolism will be assessed using SPECT at baseline, 3 monthsThe counts for each different Broadmann area values will be calculated. The changes at 3 months from baseline will be compared.'}], 'secondaryOutcomes': [{'measure': 'Fibromyalgia Impact on quality of life', 'timeFrame': 'Change after 3 months', 'description': 'Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100)'}, {'measure': 'Short form health survey (sf-36)', 'timeFrame': 'Change after 3 months', 'description': 'Quality of live will be evaluated by Quality of Life RAND Short form 36 questionnaire (SF36).(scale 0-100) higher score means better outcome.'}, {'measure': 'Stress', 'timeFrame': 'Change after 3 months t', 'description': 'Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51)'}, {'measure': 'Psychological symptoms', 'timeFrame': 'Change after 3 months', 'description': 'Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20)'}, {'measure': 'Sensory symptoms', 'timeFrame': 'Change after 3 months', 'description': 'Sensory symptoms will be evaluated using the Sensory Profile questionnaires .'}, {'measure': 'Somatoform Dissociation Questionnaire (SDQ-20)', 'timeFrame': 'Change after 3 months', 'description': 'Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20).'}, {'measure': 'Childhood trauma psychological effects', 'timeFrame': 'Change after 3 months', 'description': 'Childhood trauma psychological effects will be evaluated using the Childhood Trauma Questionnaire (CTQ) questionnaires.(scale 0-125)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['more than 1 year'], 'conditions': ['Fibromyalgia', 'Chronic Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '30618929', 'type': 'DERIVED', 'citation': 'Hadanny A, Bechor Y, Catalogna M, Daphna-Tekoah S, Sigal T, Cohenpour M, Lev-Wiesel R, Efrati S. Hyperbaric Oxygen Therapy Can Induce Neuroplasticity and Significant Clinical Improvement in Patients Suffering From Fibromyalgia With a History of Childhood Sexual Abuse-Randomized Controlled Trial. Front Psychol. 2018 Dec 17;9:2495. doi: 10.3389/fpsyg.2018.02495. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': "The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on 2 types of patients' population suffering from chronic pain syndrome (Fibromyalgia): patients with history of psychological trauma and patients with history of traumatic brain injury.", 'detailedDescription': 'This study is a prospective clinical trial. After signing a written informed consent, all patients will be invited to medical evaluation including pain sensitivity examination and a series of questionnaires. In addition, all patients will have chest X-ray, cognitive evaluation, brain MRI and brain Single-photon emission computed tomography (SPECT)\n\n. A second brain MRI, brain SPECT, pain sensitivity evaluation and questionnaires will be done after 3 months of treatment (60 sessions of HBOT). The HBOT procedure will be performed at the Sagol center for hyperbaric medicine and research of Assaf Harofeh Medical Center, Israel.\n\nThe following HBOT protocol will be applied for all patients: 12 weeks, 5 times per week, daily administration of 100% O2 for 90 minutes at a pressure of 2 absolute atmospheres (ATA) including 5 minutes air breaks every 30 minutes.\n\nPatients with history of psychological trauma are also being treated with creative art psychotherapy. These patients will be randomly assigned to one of the two groups: (1) single intervention with creative art psychotherapy (psychotherapy group); (2) combined concurrent intervention of HBOT and creative art psychotherapy. Groups 1 will serve as controls during the first 3 months and then will be crossed to get HBOT. Before the cross to the HBOT they will have 2nd full evaluation (questioners and brain imaging).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females\n* Age over 18\n* Known fibromyalgia (chronic pain syndrome) for more than 1 year\n\nExclusion Criteria:\n\n* Any past hyperbaric treatment prior to inclusion\n* Patients with chest x-ray pathology incompatible with hyperbaric environment\n* Patients with middle ear problems\n* Patients, who cannot "pump", equals middle ear pressure, effectively\n* Patients who suffer from claustrophobia\n* Inability or Refusing to sign the Informed Consent Form'}, 'identificationModule': {'nctId': 'NCT03376269', 'acronym': 'HBOTCSA', 'briefTitle': 'HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma', 'orgStudyIdInfo': {'id': '202/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Combined HBOT/psychotherapy', 'description': 'combined concurrent intervention of HBOT and creative art psychotherapy.', 'interventionNames': ['Biological: HBOT', 'Behavioral: Psychotherapy']}, {'type': 'OTHER', 'label': 'psychotherapy', 'description': 'single intervention with creative art psychotherapy', 'interventionNames': ['Behavioral: Psychotherapy']}], 'interventions': [{'name': 'HBOT', 'type': 'BIOLOGICAL', 'description': '•HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments', 'armGroupLabels': ['Combined HBOT/psychotherapy']}, {'name': 'Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions', 'armGroupLabels': ['Combined HBOT/psychotherapy', 'psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ẕerifin', 'country': 'Israel', 'facility': 'Assaf-Harofeh Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'overallOfficials': [{'name': 'Shai a Efrati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asaf-Harofhe MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Sagol Center for Hyperbaric medicine and Research', 'investigatorFullName': 'Prof. Shay Efrati', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}