Fibromyalgia Clinical Trial
Official title:
The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia)
The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients suffering from chronic pain syndrome (Fibromyalgia).
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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