Fibromyalgia, Chronic Pain
Conditions
Keywords
Hyperbaric Oxygen Treatment, Fibromyalgia, Global Function, Sleep, Chronic Pain, Depression, Anxiety
Brief summary
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.
Interventions
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)
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Function Improvement Questionnaire (Revised) score ≥ 60 during the baseline assessment.
Exclusion criteria
* Women with positive pregnancy test or plans to become pregnant during the study period * Claustrophobia * Seizure disorder * Active asthma * Severe chronic obstructive pulmonary disease * Previous thoracic surgery * History of pneumothorax * History of severe congestive heart failure with left ventricular ejection fraction \< 30% * Unstable angina * Chronic sinusitis * Chronic or acute otitis media or major ear drum trauma * Current treatment with bleomycin, cisplatin, doxorubicin and disulfiram * Participation in another investigative drug or device trial currently or within the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants finishing the study protocol | 3 months post treatment | Feasibility as a number of participants finishing the study protocol |
| Number of participants experiencing intervention related adverse events | Start of Treatment to post 3 months | Safety as a proportion of patients experiencing intervention-related adverse events during the study period |
Countries
Canada
Outcome results
None listed