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Oxygen chamber vs. pills: new hope for Trauma-Linked fibromyalgia?

NCT ID NCT04316702

Disease control Sponsor: Assaf-Harofeh Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) works better than standard medications (Cymbalta or Lyrica) for fibromyalgia triggered by emotional trauma. 48 adults completed the trial, and researchers measured symptom improvement using questionnaires. The goal was to see if this oxygen therapy could offer a drug-free way to manage fibromyalgia symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hyperbaric oxygen therapy (HBOT) and standard drugs (Cymbalta or Lyrica)
What this could lead to
If HBOT proves better than drugs, it could offer a new, non-drug option for managing fibromyalgia symptoms in people with a history of emotional trauma.
What could go wrong
This is a small, completed trial with only 48 participants. Results may not apply to all fibromyalgia patients, and HBOT requires many sessions, which may not be practical or accessible for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

48 people

The number who actually took part.

Started

Mar 2020

Finished

Nov 2023

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Emotional trauma Fibromyalgia

Contacts and locations

Locations

  • hyperbaric center Asaf harofe medical center

    Rishon LeZiyyon, Israel

More trials for these conditions

Other studies related to the condition(s) this trial covers.