Hyperbaric Oxygen vs. Standard Pharmaceutical Therapies for Fibromyalgia Syndrome – Prospective, Randomized Crossover Clinical Trial


The study will include 70 fibromyalgia patients in whom physical trauma, such mild traumatic
brain injury (mTBI), could be considered as the trigger for FMS. Each participant will be
examined at the time of recruitment and a diagnosis of FMS will be verified, based on the
updated 2016 diagnostic criteria In the current study the investigators will recruit patients
not currently being treated with medications specific for FMS, including anti-depression
drugs, gabapentanoids and tricyclics, opiods and medical cannabis. Patients who are on such
treatment will be required to discontinue treatment 2 weeks before recruitment.

Patients will undergo randomization upon recruitment to one of the two study groups. One
group will proceed to a course of HBOT treatment while the second group will commence with
standard treatment for FMS, as outlined in the Israeli guidelines for the diagnosis and
treatment of FMS [41]. These patients will be given detailed education regarding the nature
of FMS as well as recommendations regarding non – pharmacological interventions recommended
for FMS, including graded physical exercise, hydrotherapy, movement-meditative treatments
(e.g. Tai Chi) and cognitive behavioral treatment (CBT).

HBOT protocol: a total of 60 daily hyperbaric oxygen treatment sessions will be administrated
5 days per week. 60 sessions will include exposure of 90 minutes to 100% at 2 Absolute
atmospheres (ATA), with 5 minutes air breaks every 20 minutes.

Pharmaceutical protocol: patients will be offered pharmacological treatment with one of the
two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and
Lyrica. Treatment with Lyrica will start at a dose of 75 mg at bedtime while treatment with
Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 6 weeks
patients will be evaluated and dose will be adjusted as necessary. Patients may also be
switched from one medication to the other based according to clinical judgment.

Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is
completed, all patients in both groups will be offered to switch to the alternative treatment




Hyperbaric oxygen therapy

Start Date:

November 1, 2017


Assaf-Harofeh Medical Center

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