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Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome

NCT03325959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-04-22

No results posted yet for this study

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).

Conditions

  • Fibromyalgia
  • Hyperbaric Oxygen

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

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • Shai a Efrati, MD · Asaf-Harofhe MC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03325959 on ClinicalTrials.gov