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Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome
Sponsor: Assaf-Harofeh Medical Center
Summary
The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with significant improvement in life quality; furthermore, the investigators were able to demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the hyperactivity in posterior regions and elevation of the reduced activity in frontal areas. In the proposed study, the investigators intend to both repeat and expand our previous findings, treating FMS patients with HBOT while performing an extensive of evaluation both before and after treatment. In the current study, the investigators plan to compare HBOT to current standard of care of FMS (pharmacological and non - pharmacological).
Official title: Hyperbaric Oxygen vs. Standard Pharmaceutical Therapies for Fibromyalgia Syndrome - Prospective, Randomized Crossover Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2017-03-01
Completion Date
2022-06-01
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
Hyperbaric oxygen therapy (HBOT) treatment
60 HBOT sessions at 2 ATA 100% oxygen
Cymbalta / Lyrica treatment
one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica.
Crossover Hyperbaric oxygen therapy
60 HBOT sessions at 2 ATA 100% oxygen after crossover
Locations (1)
Assaf-Harofeh Medical Center
Ẕerifin, Israel