HBOT in Fibromyalgia

Chronic Pain Clinical Trial

Official title:

Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467218
• Other study ID #: 14-7888-A
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2018

Study information

• Verified date: October 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Hyperbaric Oxygen 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)

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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