Clinical trial NCT02467218: HBOT in Fibromyalgia
Official title: Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Keywords: Hyperbaric Oxygen Treatment
Fibromyalgia
Global Function
Sleep
Chronic Pain
Depression
Anxiety
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants finishing the study protocol
timeFrame: 3 months post treatment
measure: Number of participants experiencing intervention related adverse events
timeFrame: Start of Treatment to post 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Rita Katznelson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curtis K, Katz J, Djaiani C, O'Leary G, Uehling J, Carroll J, Santa Mina D, Clarke H, Gofeld M, Katznelson R. Evaluation of a Hyperbaric Oxygen Therapy Intervention in Individuals with Fibromyalgia. Pain Med. 2021 Jun 4;22(6):1324-1332. doi: 10.1093/pm/pnaa416.