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COMPLETED
NCT03325959
NA

Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome

Sponsor: Assaf-Harofeh Medical Center

View on ClinicalTrials.gov

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

Interventions

DEVICE

Hyperbaric oxygen therapy (HBOT) treatment

60 HBOT sessions at 2 ATA 100% oxygen

DRUG

Cymbalta / Lyrica treatment

one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica.

DEVICE

Crossover Hyperbaric oxygen therapy

60 HBOT sessions at 2 ATA 100% oxygen after crossover

Locations (1)

Assaf-Harofeh Medical Center

Ẕerifin, Israel