Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma
Key facts
- Who runs it
- Assaf-Harofeh Medical Center
- Where
- Israel1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 48 people enrolled
- Started
- 1 Mar 2020
- Ended
- 30 Nov 2023
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Hyperbaric oxygen therapy (HBOT) treatment
- Cymbalta / Lyrica - Drug treatment
- Record updated
- 21 April 2026
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- FM diagnosis based on the widespread pain index (WPI) and the Symptom Severity Score (SSS)
- Score at the trauma questionnaire indicating low, moderate or severe trauma in one of the criteria specified in the questionnaire
- Ability to provide informed consent
- Age>18
Who cannot take part
- Currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica)
- Previous suicidal attempt/s
- Previous HBOT for any other reason prior to their inclusion
- Previous neurological conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.); Brain tumors; Skull base fractures; Active malignancy; s/p neurosurgery
- Presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders
- History of traumatic brain injury (TBI)
- Major psychiatric disorder (such as major depression, schizophrenia, bi-polar disorder)
- Inner ear disease
- Chronic renal failure (eGFR< 60 ml/min)
- Other FM etiologies
- Contraindications to both Lyrica and Cymbalta
- Does not take part in psychotherapy on a weekly basis (minimum)
- Chest pathology (including active asthma)
- Claustrophobia
- Inability to perform awake brain MRI test
- Active Smoking
- Pregnancy or not committing to not getting pregnant during the study period
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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).
The 2 groups in the trial
- Hyperbaric OxygenExisting treatment, for comparison
60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Treatment: Hyperbaric oxygen therapy (HBOT) treatment
- PharmacotherapyExisting treatment, for comparison
Two medications currently licensed for the treatment of FM in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 2 weeks, patients will be evaluated and dose will be adjusted as necessary and tolerated, up to the maximum dosage recommended for FM. Patients may also be switched from one medication to the other according to clinical judgment of the physician.
Treatment: Cymbalta / Lyrica - Drug treatment
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Hyperbaric Oxygen Therapy vs. Pharmaceutical Therapy in Patients Suffering From Fibromyalgia That Was Induced by Emotional Trauma: Prospective, Randomized, Two Active Arms Clinical Trial
- Record updated
- 21 April 2026