HBOT in Fibromyalgia

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02467218

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Nov 1, 2015

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Number of participants finishing the study protocol [3 months post treatment]
Feasibility as a number of participants finishing the study protocol
Number of participants experiencing intervention related adverse events [Start of Treatment to post 3 months]
Safety as a proportion of patients experiencing intervention-related adverse events during the study period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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