Chronic Pain Clinical Trial
Official title:
Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function
NCT number | NCT02467218 |
Other study ID # | 14-7888-A |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | December 2018 |
Verified date | October 2018 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 2018 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants finishing the study protocol | Feasibility as a number of participants finishing the study protocol | 3 months post treatment | |
Primary | 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 |
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