HBOT in Fibromyalgia

NCT ID: NCT02467218

Last Updated: 2019-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-12-31

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.

Conditions

Fibromyalgia; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hyperbaric Oxygen Treatment

Intervention Type: OTHER

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)

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.

Group Type: EXPERIMENTAL

Hyperbaric Oxygen Treatment

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rita Katznelson

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33594439 (View on PubMed)

Other Identifiers

14-7888-A

Identifier Type: -

Identifier Source: org_study_id