HBOT in Fibromyalgia
Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function
1 other identifier
interventional
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2015
CompletedFirst Posted
Study publicly available on registry
June 9, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 17, 2019
October 1, 2018
1.8 years
April 20, 2015
May 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants finishing the study protocol
Feasibility as a number of participants finishing the study protocol
3 months post treatment
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
Study Arms (2)
Immediate Hyperbaric Oxygen Treatment
EXPERIMENTALIf 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.
Delayed Hyperbaric Oxygen Treatment
EXPERIMENTALIf 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.
Interventions
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)
Eligibility Criteria
You may qualify if:
- Function Improvement Questionnaire (Revised) score ≥ 60 during the baseline assessment.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Related Publications (1)
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.
PMID: 33594439DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rita Katznelson
University Health Network, Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2015
First Posted
June 9, 2015
Study Start
November 1, 2015
Primary Completion
August 1, 2017
Study Completion
December 1, 2018
Last Updated
May 17, 2019
Record last verified: 2018-10