Trial record 9 of 126 for:    fibromyalgia | Open Studies | Interventional Studies

HBOT in Fibromyalgia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2015 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02467218
First received: April 20, 2015
Last updated: June 8, 2015
Last verified: June 2015
  Purpose

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 Intervention
Fibromyalgia
Chronic Pain
Other: Hyperbaric Oxygen Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Global Function (Fibromyalgia Impact Revised Questionnaire) [ Time Frame: 3 months post treatment ] [ Designated as safety issue: No ]
    Fibromyalgia Impact Revised Questionnaire will be used to determine Global Function, the impact on patients well being describing physical functioning, symptoms and overall impact of fibromyalgia on function.


Estimated Enrollment: 72
Study Start Date: June 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Hyperbaric Oxygen Treatment
If you are randomized to the group receiving the intervention, you will be receiving a baseline assessment MRI and subsequently receiving hyperbaric oxygen treatment for 90 minutes, once daily, five times a week for 4 consecutive weeks (20 treatments with 100% oxygen at 2.4 ATA). A follow-up MRI will be performed after your last day of treatment.
Other: Hyperbaric Oxygen Treatment
Baseline and follow up MRI and Oxygen treatrment, 90 minutes, once daily, five times a week for 4 consecutive weeks in the hyperbaric chamber (20 treatments with 100% oxygen at 2.4 ATA)
Experimental: Delayed Hyperbaric Oxygen Treament
If you are assigned to the cross group, you will also receive a baseline assessment MRI. However, you will be followed-up in a controlled manner for 3 months. After 3 months, you will be receiving hyperbaric oxygen treatment identical to Group A and a follow-up MRI will be performed after your last treatment.
Other: Hyperbaric Oxygen Treatment
Baseline and follow up MRI and Oxygen treatrment, 90 minutes, once daily, five times a week for 4 consecutive weeks in the hyperbaric chamber (20 treatments with 100% oxygen at 2.4 ATA)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02467218

Contacts
Contact: Rita Katznelson, MD 416-340-4800 ext 6273 rita.katznelson@uhn.ca

Locations
Canada, Ontario
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada
Contact: Rita Katznelson, MD    416-586-4800 (2831)    rita.katznelson@uhn.ca   
University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Rita Katznelson, MD    416-340-4800 (6273)    rita.katznelson@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02467218     History of Changes
Other Study ID Numbers: 14-7888-A
Study First Received: April 20, 2015
Last Updated: June 8, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Hyperbaric Oxygen Treatment
Fibromyalgia
Global Function
Sleep
Chronic Pain
Depression
Anxiety

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2015