Overview

This trial is active, not recruiting.

Conditions fibromyalgia, chronic pain
Treatment hyperbaric oxygen treatment
Sponsor University Health Network, Toronto
Start date November 2015
End date September 2016
Trial size 16 participants
Trial identifier NCT02467218, 14-7888-A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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)
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.
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 Outcomes

Measure
Number of participants finishing the study protocol
time frame: 3 months post treatment
Number of participants experiencing intervention related adverse events
time frame: Start of Treatment to post 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function
Principal investigator Rita Katznelson
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.