HBOT in Fibromyalgia

May 15, 2019 updated by: University Health Network, Toronto

Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants finishing the study protocol
Time Frame: 3 months post treatment
Feasibility as a number of participants finishing the study protocol
3 months post treatment
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
Start of Treatment to post 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Rita Katznelson, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

May 17, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-7888-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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