drugset / Trial / NCT04316702

Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma

NCT04316702

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 this study, the investigators intend to both repeat and expand the investigator's previous findings, treating FMS patients with history of emotional trauma 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
2020-03-01
Primary completion
2023-11-30
Completion
2023-11-30

Drugs

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

Indications