An interventional study of Hyperbaric oxygen in Fibromyalgia, sponsored by Assaf-Harofeh Medical Center. Completed at 1 site in Israel. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-04-09.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment
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).
1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
hyperbaric oxygen therapy during the first 2 months
Other: Hyperbaric oxygen
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.
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
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Assaf-Harofeh Medical Center →