Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma (NCT04316702) | Clinical Trial Compass
CompletedNot Applicable
Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma
Israel48 participantsStarted 2020-03-01
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 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).
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.
* History of traumatic brain injury (TBI)
* Other FM etiologies
* Currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica)
* Contraindications to both Lyrica and Cymbalta
* Major psychiatric disorder (such as major depression, schizophrenia, bi-polar disorder)
* Previous suicidal attempt/s
* Does not take part in psychotherapy on a weekly basis (minimum)
* Previous HBOT for any other reason prior to their inclusion
* Chest pathology (including active asthma)
* Inner ear disease
* Claustrophobia
* Inability to perform awake brain MRI test
* Chronic renal failure (eGFR\< 60 ml/min)
* Previous neurological conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.); Brain tumors; Skull base fractures; Active malignancy; s/p neurosurgery
* Active Smoking
* Pregnancy or not committing to not getting pregnant during the study period
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.