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Oxygen therapy shows promise for fibromyalgia pain relief

NCT ID NCT03325959

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) could reduce pain and improve quality of life in people with fibromyalgia, compared to standard medications like Cymbalta or Lyrica. Seventy-six adults with fibromyalgia and a history of physical trauma took part. The goal was to see if this non-drug approach could offer a new way to manage 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
What this could lead to
If it works, this could provide a non-drug option to ease fibromyalgia pain and improve daily life.
What could go wrong
This is a small, completed trial with 76 participants. The results may not apply to everyone, and hyperbaric oxygen therapy is time-consuming and not widely available.

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

76 people

The number who actually took part.

Started

Mar 2017

Finished

Jun 2022

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 years and older

Sex

Anyone

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: * 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

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Conditions

The condition(s) this trial relates to.

fibromyalgia Pain

As listed by the trial registrant

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

Fibromyalgia Hyperbaric oxygen

Contacts and locations

Locations

  • Assaf-Harofeh Medical Center

    Ẕerifin, 70300, Israel

More trials for these conditions

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