HBOT in Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function

Conditions
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Fibromyalgia, Chronic Pain

Intervention / Treatment
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* Other: Hyperbaric Oxygen Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Hyperbaric Oxygen Treatment<br>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. | Other: Hyperbaric Oxygen Treatment<br>* 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)<br>|
| Experimental: Delayed Hyperbaric Oxygen Treatment<br>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. | Other: Hyperbaric Oxygen Treatment<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants finishing the study protocol | Feasibility as a number of participants finishing the study protocol | 3 months post treatment | 
| Number of participants experiencing intervention related adverse events | Safety as a proportion of patients experiencing intervention-related adverse events during the study period | Start of Treatment to post 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Hyperbaric Oxygen Treatment, Fibromyalgia, Global Function, Chronic Pain, Depression, Anxiety