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HBOT in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT02467218
Recruitment Status : Completed
First Posted : June 9, 2015
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Pain Other: Hyperbaric Oxygen Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function
Actual Study Start Date : November 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Hyperbaric Oxygen Treatment
If a participant is randomized to the group receiving the intervention, the participant will be receiving a baseline assessment functional magnetic resonance imaging (fMRI) and subsequently receiving hyperbaric oxygen treatment for 90 minutes, once daily, five times a week for 8 consecutive weeks (40 treatments with 100% oxygen at 2.0 ATA). A follow-up fMRI will be performed after the last day of treatment.
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)

Experimental: Delayed Hyperbaric Oxygen Treatment
If the participant is assigned to the cross group, the participant will also receive a baseline assessment functional magnetic resonance imaging (fMRI). However, it will be followed-up in a controlled manner for 3 months. After 3 months, the participant will be receiving hyperbaric oxygen treatment identical to Group A and a follow-up fMRI will be performed after the last treatment.
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)




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467218


Locations
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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Mount Sinai Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Rita Katznelson University Health Network, Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02467218    
Other Study ID Numbers: 14-7888-A
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: October 2018
Keywords provided by University Health Network, Toronto:
Hyperbaric Oxygen Treatment
Fibromyalgia
Global Function
Sleep
Chronic Pain
Depression
Anxiety
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases