drugset / Trial / NCT03325959

Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome

NCT03325959

Completed 76 enrolled Assaf-Harofeh Medical Center
RandomizedCrossoverDouble-blindTreatment

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).

Timeline

Start
2017-03-01
Primary completion
2022-06-01
Completion
2022-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Duloxetine Small molecule 30 mg
Comparator Pregabalin Small molecule 75 mg

Indications