Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT04316702
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2020-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional 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': 'D006931', 'term': 'Hyperbaric Oxygenation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "randomization by computer, the patient and her primary care physician will know the treatment received. Any side effects during therapy will be reported to the care providers and nurses and physicians unrelated to the study. Investigators and outcome assessors will not know the patient's arm."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomized controlled trial using conventional pharmacotherapy treatment compared to hyperbaric oxygen therapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-18', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibromyalgia Impact Questionnaire (FIQ) questionnaire', 'timeFrame': 'at 3 months', 'description': 'Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of treatment period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome'}, {'measure': 'Fibromyalgia Impact Questionnaire (FIQ) questionnaire', 'timeFrame': 'at 6 months', 'description': 'Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of follow up period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome'}], 'secondaryOutcomes': [{'measure': 'Widespread pain index questionnaire', 'timeFrame': 'at baseline, 3 months, 6 months', 'description': 'Fibromyalgia syndrome symptoms questionnaire named:Wide Spread Pain Index (scale 0-19, higher score means worse outcome)'}, {'measure': 'Symptoms severity scale questionnaire', 'timeFrame': 'at baseline, 3 months, 6 months', 'description': 'Fibromyalgia syndrome symptoms questionnaire named:Symptom Severity Scale (SSS) (scale 0-12, higher score means worse outcome)'}, {'measure': 'Post traumatic stress disorder (PTSD) symptoms scale (PSS) questionnaire', 'timeFrame': 'at baseline, 3 months, 6 months', 'description': 'a 17-item semi-structured interview that assesses the presence and severity of Diagnostic and Statistical Manual (DSM-IV) PTSD symptoms related to a single identified traumatic event in individuals with a known trauma history. scale 0-51, higher score means worse outcome'}, {'measure': 'Medical somatic dissociation questionnaire (MSDQ)', 'timeFrame': 'at baseline, 3 months, 6 months', 'description': 'assess somatic dissociation in the healthcare system setting, Scale 5-130, higher score means worse outcome'}, {'measure': 'Recovery promoting relationships scale (RPRS)', 'timeFrame': 'at baseline, 3 months, 6 months', 'description': "assesses patient-therapist relationships from the patient's perspective."}, {'measure': 'the brief symptom inventory (BSI-18)', 'timeFrame': 'at baseline, 3 months, 6 months', 'description': 'evaluate psychological distress, three sub-scales: depression, anxiety, and somatization. scale of 0-24, higher score means worse outcome.'}, {'measure': 'Beck depression inventory (BDI)', 'timeFrame': 'at baseline, 3 months, 6 months', 'description': 'a 21-question multiple choice self-report inventory, designed to measure severity of depression. scale of 0-63, higher score means worse outcome'}, {'measure': 'Short form health survey (sf-36)', 'timeFrame': 'at baseline, 3 months, 6 months', 'description': 'Quality of life questionnaire, scale of 0-100, higher score means better outcome'}, {'measure': "patient's global impression of change PGIC questionnaire", 'timeFrame': 'at 3 months, at 6 months', 'description': "patient's global impression of change questionnaire, scale of 1-7, higher score means better outcome"}, {'measure': 'draw a person (DAP) assignment', 'timeFrame': 'at baseline, 3 months, 6 months', 'description': 'self drawing tool, allows the expression of hidden or repressed thoughts and feelings in a relatively rapid and simple way by passing the censorship defensive mechanism'}, {'measure': 'Heat pain threshold', 'timeFrame': 'at baseline, 3 months', 'description': 'Heat pain threshold is determined as the minimum temperature causing pain. Thermal pain is induced with thermal electrode (thermode). Thermode temperature will initially be set at 32.0°C and gradually increase at a rate of 0.3°C/sec. Participants will be instructed to report when the sensation produced by the thermode changed from heat sensation to pain (heat-pain threshold). This procedure will be conducted three times for every subject and the mean of the trials will be calculated.'}, {'measure': 'conditioned pain modulation using Heat test-stimulus (HTS)', 'timeFrame': 'at baseline, 3 months', 'description': "Following heat pain thresholds assessments, the thermode will be applied on the forearm for 120 seconds at constant temperature. The temperature will be individually adapted to induce a mean pain intensity of 50/100, Participant's pain intensity will be evaluated by numeric pain rating scale (NPRS) ranging from 0 (no pain) to 100 (most intense pain tolerable). The 120-second HTS will be done before and during cold water immersion of the contralateral hand in 10 Celsius degrees, using the same thermode temperature to measure conditioned pain modulation (CPM). CPM efficiency will be evaluated by computing the difference in mean pain intensity induced by the pressure stimulus and the Heat test-stimulus (HTS) before and during the Cold water immersion of the opposite hand. Thus, effective pain inhibitory mechanisms are represented by higher (positive) values"}, {'measure': 'Cerebral blood volume', 'timeFrame': 'at baseline, 3 months', 'description': 'Cerebral blood volume (in milliliter) will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).'}, {'measure': 'Cerebral blood Flow', 'timeFrame': 'at baseline, 3 months', 'description': 'Cerebral blood volume (in milliliter/min) will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).'}, {'measure': 'Fractional anisotropy', 'timeFrame': 'at baseline, 3 months', 'description': 'Brain microstructure imaging will evaluate fractional anisotropy (FA , scale 0-1 in each region of interest. The MRI protocol will include diffusion tensor imaging (DTI)'}, {'measure': 'Mean diffusivity', 'timeFrame': 'at baseline, 3 months', 'description': 'Brain microstructure imaging will evaluate mean diffusivity (MD, scale 0-1 in each region of interest. The MRI protocol will include diffusion tensor imaging (DTI).'}, {'measure': 'Brain function imaging', 'timeFrame': 'at baseline, 3 months', 'description': 'Resting state fMRI(rsfMRI or R-fMRI)- a method of functional brain imaging that can be used to evaluate regional interactions that occur when a subject is not performing an explicit task. This resting brain activity is observed through changes in blood flow in the brain which creates what is referred to as a blood-oxygen-level dependent (BOLD) signal that can be measured using functional Magnetic Resonance Imaging (fMRI).'}, {'measure': 'Metabolic Brain function imaging', 'timeFrame': 'at baseline, 3 months', 'description': 'Brain Single photon emission computed tomography (SPECT) will be conducted.'}, {'measure': 'Brain functionality', 'timeFrame': 'at baseline, 3 months', 'description': 'FMRI tasks will evaluate brain function during cognitive (working memory task) and emotional tasks (emotion recognition task)'}, {'measure': 'NeuroTrax', 'timeFrame': 'at baseline, 3 months', 'description': 'computerized cognitive evaluation battery'}, {'measure': 'CANTAB Cambridge Neuropsychological Test Automated Battery', 'timeFrame': 'at baseline, 3 months', 'description': 'computerized cognitive evaluation battery'}, {'measure': 'Physical activity', 'timeFrame': 'at baseline, 3 months', 'description': 'The daily physical activity will be objectively tracked by Garmin watch technology. The watch will be also wired during night for measurements of the time asleep, restless and awake, trackers help you understand each night to make the most of each day'}, {'measure': 'Inflammatory cytokines', 'timeFrame': 'at baseline, 3 months', 'description': 'Blood Tests will include: IL-1, IL-6, Tumor necrosis factor-alpha, C-reactive protein (CRP).'}, {'measure': 'Endocrine system', 'timeFrame': 'at baseline, 3 months', 'description': 'Free cortisol, Adrenocorticotropic hormone (ACTH) in blood tests and a hair sample for cortisol levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia', 'Emotional Trauma']}, 'descriptionModule': {'briefSummary': "The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with significant improvement in life quality; furthermore, the investigators were able to demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the hyperactivity in posterior regions and elevation of the reduced activity in frontal areas.\n\nIn this study, the investigators intend to both repeat and expand the investigator's previous findings, treating FMS patients with history of emotional trauma with HBOT, while performing an extensive of evaluation both before and after treatment.\n\nIn the current study, the investigators plan to compare HBOT to current standard of care of FMS (pharmacological and non - pharmacological).", 'detailedDescription': 'The study will include 60 fibromyalgia patients in whom emotional trauma, such as childhood abuse, could be considered as the trigger for FMS. Each participant will be examined at the time of recruitment and a diagnosis of FMS will be verified, based on the updated 2016 diagnostic criteria. In the current study the investigators will recruit patients not currently being treated with the target medications (Lyrica or Cymbalta).\n\nPatients will undergo randomization upon recruitment to one of the two study groups. One group will proceed to a course of HBOT treatment while the second group will commence with standard treatment for FMS, as outlined in the Israeli guidelines for the diagnosis and treatment of FMS .\n\nHBOT protocol: a total of 60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. 60 sessions will include exposure of 90 minutes to 100% at 2 Absolute atmospheres (ATA), with 5 minutes air breaks every 20 minutes.\n\nPharmaceutical protocol: patients will be offered pharmacological treatment with one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 2 weeks, patients will be evaluated and dose will be adjusted as necessary and tolerated, up to the maximum dosage recommended for FM. Patients may also be switched from one medication to the other according to clinical judgment of the physician.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FM diagnosis based on the widespread pain index (WPI) and the Symptom Severity Score (SSS).\n* Score at the trauma questionnaire indicating low, moderate or severe trauma in one of the criteria specified in the questionnaire.\n* Ability to provide informed consent\n* Age\\>18\n\nExclusion Criteria:\n\n* Presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.\n* History of traumatic brain injury (TBI)\n* Other FM etiologies\n* Currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica)\n* Contraindications to both Lyrica and Cymbalta\n* Major psychiatric disorder (such as major depression, schizophrenia, bi-polar disorder)\n* Previous suicidal attempt/s\n* Does not take part in psychotherapy on a weekly basis (minimum)\n* Previous HBOT for any other reason prior to their inclusion\n* Chest pathology (including active asthma)\n* Inner ear disease\n* Claustrophobia\n* Inability to perform awake brain MRI test\n* Chronic renal failure (eGFR\\< 60 ml/min)\n* Previous neurological conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.); Brain tumors; Skull base fractures; Active malignancy; s/p neurosurgery\n* Active Smoking\n* Pregnancy or not committing to not getting pregnant during the study period'}, 'identificationModule': {'nctId': 'NCT04316702', 'briefTitle': 'Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Hyperbaric Oxygen Therapy vs. Pharmaceutical Therapy in Patients Suffering From Fibromyalgia That Was Induced by Emotional Trauma: Prospective, Randomized, Two Active Arms Clinical Trial', 'orgStudyIdInfo': {'id': 'ASF-20-0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hyperbaric Oxygen', 'description': '60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes', 'interventionNames': ['Device: Hyperbaric oxygen therapy (HBOT) treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacotherapy', 'description': 'Two medications currently licensed for the treatment of FM in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 2 weeks, patients will be evaluated and dose will be adjusted as necessary and tolerated, up to the maximum dosage recommended for FM. Patients may also be switched from one medication to the other according to clinical judgment of the physician.', 'interventionNames': ['Drug: Cymbalta / Lyrica - Drug treatment']}], 'interventions': [{'name': 'Hyperbaric oxygen therapy (HBOT) treatment', 'type': 'DEVICE', 'description': '60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes', 'armGroupLabels': ['Hyperbaric Oxygen']}, {'name': 'Cymbalta / Lyrica - Drug treatment', 'type': 'DRUG', 'description': 'one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Two medications currently licensed for the treatment of FM in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning).', 'armGroupLabels': ['Pharmacotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rishon LeZiyyon', 'country': 'Israel', 'facility': 'hyperbaric center Asaf harofe medical center', 'geoPoint': {'lat': 31.97102, 'lon': 34.78939}}], 'overallOfficials': [{'name': 'Shai a Efrati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asaf-Harofhe MC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The Emili Sagol Creative Arts Therapies Research Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Sagol center for hyperbaric medicine and research', 'investigatorFullName': 'Prof. Shay Efrati', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}