HBOT in Fibromyalgia
Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Mount Sinai Hospital
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Hyperbaric Oxygen Treatment
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.
|
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)
|
|
Experimental: Delayed Hyperbaric Oxygen Treatment
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.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants finishing the study protocol
Time Frame: 3 months post treatment
|
Feasibility as a number of participants finishing the study protocol
|
3 months post treatment
|
|
Number of participants experiencing intervention related adverse events
Time Frame: Start of Treatment to post 3 months
|
Safety as a proportion of patients experiencing intervention-related adverse events during the study period
|
Start of Treatment to post 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rita Katznelson, University Health Network, Toronto
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-7888-A
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