Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-01-26 @ 4:43 AM
Study NCT ID:
NCT02467218
Status:
COMPLETED
Last Update Posted:
2019-05-17
First Post:
2015-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HBOT in Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-15', 'studyFirstSubmitDate': '2015-04-20', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants finishing the study protocol', 'timeFrame': '3 months post treatment', 'description': 'Feasibility as a number of participants finishing the study protocol'}, {'measure': 'Number of participants experiencing intervention related adverse events', 'timeFrame': 'Start of Treatment to post 3 months', 'description': 'Safety as a proportion of patients experiencing intervention-related adverse events during the study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyperbaric Oxygen Treatment', 'Fibromyalgia', 'Global Function', 'Sleep', 'Chronic Pain', 'Depression', 'Anxiety'], 'conditions': ['Fibromyalgia', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '33594439', 'type': 'DERIVED', 'citation': "Curtis K, Katz J, Djaiani C, O'Leary G, Uehling J, Carroll J, Santa Mina D, Clarke H, Gofeld M, Katznelson R. Evaluation of a Hyperbaric Oxygen Therapy Intervention in Individuals with Fibromyalgia. Pain Med. 2021 Jun 4;22(6):1324-1332. doi: 10.1093/pm/pnaa416."}]}, 'descriptionModule': {'briefSummary': 'Fibromyalgia (FM) is a chronic pain condition affecting several millions of Canadians. Although the etiology and pathophysiology are poorly understood, there is a well-recognized association between muscular pain in fibromyalgia and muscular hypoperfusion, hypoxia, abnormal muscle metabolism and oxidative stress. Currently there is no cure for FM. Pharmacological and non-pharmacological strategies are directed to control symptoms such as pain, fatigue, non-restorative sleep and depression.\n\nHyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than 1 absolute atmosphere. Physiological effect of HBOT is based on a dramatic increase in the amount of dissolved oxygen carried by the blood which enables oxygenation of ischemic areas with compromised circulation. It also activates oxidant-antioxidant system, stimulates angio- and neurogenesis, modulates inflammatory response, induces brain neuroplasticity and possesses analgesic effect.\n\nWhile some interventions offer benefit for some patients, additional treatment alternatives are needed for patients with FM in whom currently available options are either ineffective or poorly tolerated. Given its physiological effect, HBOT could be considered as a potential therapy for treatment of underlying muscular hypoxia, optimizing oxidant- antioxidant system and controlling FM symptoms. The results from this study could therefore provide new information supporting the basic science underling the pathophysiology of this disease and stimulate novel therapies for patients suffering with FM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Function Improvement Questionnaire (Revised) score ≥ 60 during the baseline assessment.\n\nExclusion Criteria:\n\n* Women with positive pregnancy test or plans to become pregnant during the study period\n* Claustrophobia\n* Seizure disorder\n* Active asthma\n* Severe chronic obstructive pulmonary disease\n* Previous thoracic surgery\n* History of pneumothorax\n* History of severe congestive heart failure with left ventricular ejection fraction \\< 30%\n* Unstable angina\n* Chronic sinusitis\n* Chronic or acute otitis media or major ear drum trauma\n* Current treatment with bleomycin, cisplatin, doxorubicin and disulfiram\n* Participation in another investigative drug or device trial currently or within the last 30 days'}, 'identificationModule': {'nctId': 'NCT02467218', 'briefTitle': 'HBOT in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function', 'orgStudyIdInfo': {'id': '14-7888-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Hyperbaric Oxygen Treatment', 'description': 'If a participant is randomized to the group receiving the intervention, the participant will be receiving a baseline assessment functional magnetic resonance imaging (fMRI) and subsequently receiving hyperbaric oxygen treatment for 90 minutes, once daily, five times a week for 8 consecutive weeks (40 treatments with 100% oxygen at 2.0 ATA). A follow-up fMRI will be performed after the last day of treatment.', 'interventionNames': ['Other: Hyperbaric Oxygen Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed Hyperbaric Oxygen Treatment', 'description': 'If the participant is assigned to the cross group, the participant will also receive a baseline assessment functional magnetic resonance imaging (fMRI). However, it will be followed-up in a controlled manner for 3 months. After 3 months, the participant will be receiving hyperbaric oxygen treatment identical to Group A and a follow-up fMRI will be performed after the last treatment.', 'interventionNames': ['Other: Hyperbaric Oxygen Treatment']}], 'interventions': [{'name': 'Hyperbaric Oxygen Treatment', 'type': 'OTHER', 'description': 'Baseline and follow up fMRI and Oxygen treatment, 90 minutes, once daily, five times a week for 8 consecutive weeks in the hyperbaric chamber (40 treatments with 100% oxygen at 2.0 ATA)', 'armGroupLabels': ['Delayed Hyperbaric Oxygen Treatment', 'Immediate Hyperbaric Oxygen Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Rita Katznelson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}