Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial
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ClinicalTrials.gov Identifier: NCT01827683 |
Recruitment Status :
Completed
First Posted : April 9, 2013
Last Update Posted : April 9, 2013
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Condition or disease | Intervention/treatment | Phase |
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Fibromyalgia | Other: Hyperbaric oxygen | Not Applicable |
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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Hyperbaric oxygen therapy group
hyperbaric oxygen therapy during the first 2 months
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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
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Other: Hyperbaric oxygen
8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA. |
- Pain evaluation [ Time Frame: up to 4 months ]
- Quality of Life [ Time Frame: 0,2,4 months ]
- Brain SPECT scan [ Time Frame: 0,2,4 months ]

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Ages Eligible for Study: | 45 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
Israel | |
Hyperbaric unit, Assaf- Harofe Medical Center | |
Zerifin, Israel, 70300 |
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 |
hyperbaric oxygen fibromyalgia chronic pain syndrome |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |