Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01827683
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
Judith Ben Zvi, Assaf-Harofeh Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients suffering from chronic pain syndrome (Fibromyalgia).

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Hyperbaric oxygen Not Applicable

Detailed Description:

The study is a prospective, randomized, cross-over trial. Patients will be randomized into two groups (test and control) to receive the HBOT at the beginning of the trial or 2 months afterwards. The control group will receive its treatment after the elapsed two months.

This study will be a prospective, randomized cross over study. After signing a written informed consent, all patients will be invited to a 2 hour examination, including pain sensitivity examination and a series of questionnaires. In addition, prior to the beginning of the treatment all patients will have chest X-ray, neurological examination, cognitive evaluation and brain metabolism evaluation (SPECT scan). A similar evaluation will be done after the 8 weeks, test versus control time period, and another evaluation will be held after 16 weeks. The HBOT procedure will be performed in the hyperbaric chamber at Assaf Harofeh Medical Center, Israel.

The following HBOT protocol will be applied for the treated group: 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA. After 8 weeks the control group, that did not received HBOT, will receive the same HBOT protocols.

At baseline, after 2 months and after 4 months all patients will undergo complete neurologic and pain evaluation and brain SPECT scan (total of 3 evaluation and scan per patient).

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia)
Study Start Date : May 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Hyperbaric oxygen therapy group
hyperbaric oxygen therapy during the first 2 months
 Other: Hyperbaric oxygen
8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
Crossed group
no active intervention during the first 2 months.After 2 months will be crossed to HBOT
 Other: Hyperbaric oxygen
8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pain evaluation [ Time Frame: up to 4 months ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 0,2,4 months ]
  2. Brain SPECT scan [ Time Frame: 0,2,4 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fibromyalgia diagnosed by physical examination of pain sensitivity, by Dolorimeter and finger pressure.

Exclusion Criteria:

  • any past hyperbaric oxygen therapy
  • chest x-ray pathology which does not allow the income into the hyperbaric chamber.
  • middle ear problems.
  • patients, who cannot "pump", equals middle ear pressure, effectively.
  • patients who suffer from claustrophobia.
  • inability or Refusing to sign the Informed Consent Form
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827683


Locations
Layout table for location information
Israel
Hyperbaric unit, Assaf- Harofe Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Judith Ben Zvi, medical center, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01827683    
Other Study ID Numbers: HBOT-Fibro
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: April 9, 2013
Last Verified: April 2013
Keywords provided by Judith Ben Zvi, Assaf-Harofeh Medical Center:
hyperbaric oxygen
fibromyalgia
chronic pain syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases