Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients suffering from chronic pain syndrome (Fibromyalgia).

Detailed Description
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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).

Official Title
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The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia)

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Hyperbaric oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evaluation |  | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 0,2,4 months | 
| Brain SPECT scan |  | 0,2,4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperbaric oxygen, fibromyalgia, chronic pain syndrome