Clinical Trial – Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome

The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as
a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover
clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with
significant improvement in life quality; furthermore, the investigators were able to
demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the
hyperactivity in posterior regions and elevation of the reduced activity in frontal areas.

In the proposed study, the investigators intend to both repeat and expand our previous
findings, treating FMS patients with HBOT while performing an extensive of evaluation both
before and after treatment.

In the current study, the investigators plan to compare HBOT to current standard of care of
FMS (pharmacological and non – pharmacological).

Hyperbaric Oxygen Therapy: A New Treatment for Chronic Pain?

Abstract: BACKGROUND AND OBJECTIVE: Hyperbaric oxygen therapy (HBOT) is a treatment providing 100% oxygen at a pressure greater than that at sea level. HBOT is becoming increasingly recognized as a potential treatment modality for a broad range of ailments, including...

Clinical Trial – HBOT in Fibromyalgia

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.