Skip to main content
OpenTrials
Completed

NCT Number: NCT02467218

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric oxygen treatment

Other

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)

Primary outcomes

  1. Number of participants finishing the study protocol

    Time frame: 3 months post treatment

    Feasibility as a number of participants finishing the study protocol

  2. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 9, 2015
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.