CompletedNot Applicable

Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome

Israel76 participantsStarted 2017-03-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * FMS diagnosis, based on the updated 2016 diagnostic criteria * previous physical trauma (such as traumatic brain injury) Exclusion Criteria: * the presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders. * active malignancy, * chronic ongoing infection * major psychiatric disorders (excluding anxiety) * Patients currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica) will also be excluded * previous HBOT for any other reason prior to their inclusion; * Chest pathology incompatible with pressure changes (including active asthma); * Inner ear disease * Claustrophobia; * Inability to perform awake brain MRI test; * Previous neurologic conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.); * Brain tumors; * Skull base fractures; * s/p neurosurgery that included: ventricular drainage, subdural hematomas drainage, epidural hematomas drainage, intracerebral hemorrhage evacuation. Depressed fracture surgery, (Patients suffering from Encephalomalacia per MRI imaging will not be excluded). * Inability to provide informed consent

What they're measuring

Visual analogue Scale (VAS)

Timeframe: at 3 months

Visual analogue Scale (VAS)

Timeframe: at 6 months

Trial details

NCT IDNCT03325959

SponsorAssaf-Harofeh Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-06-01