Hyperbaric oxygen treatment
OtherBaseline 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)
NCT Number: NCT02467218
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.
Hyperbaric 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.
While 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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Mount Sinai Hospital, Toronto, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 3 months post treatment
Feasibility as a number of participants finishing the study protocol
Time frame: Start of Treatment to post 3 months
Safety as a proportion of patients experiencing intervention-related adverse events during the study period
University Health Network, Toronto
Other
Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06353100
Anxiety Disorders, Behavior
Santiago, RM, Chile
View Trial DetailsNCT00524420
Behavior, Behavioral Symptoms
Seattle, Washington, United States
View Trial DetailsNCT07642882
Behavior, Behavioral Symptoms
Boulogne-Billancourt, Île-de-France Region, France
View Trial DetailsNCT05067998
Anxiety Disorders, Anxiety Disorders and Symptoms
Dover, Delaware, United States
View Trial Details