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Can pressurized oxygen ease fibromyalgia pain? small study tests HBOT plus therapy

NCT ID NCT03376269

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study tested whether hyperbaric oxygen therapy (HBOT) combined with creative art psychotherapy can help women with fibromyalgia who have a history of psychological trauma. Thirty women received 60 sessions of HBOT plus psychotherapy. Researchers measured pain sensitivity, brain structure, and quality of life. The study is small and early, so results are not conclusive.

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) plus creative art psychotherapy
What this could lead to
If it works, this could point toward a non-drug treatment option for fibromyalgia pain, especially in patients with a history of psychological trauma.
What could go wrong
This is a very small, early study with only 30 women, so results may not apply to everyone. HBOT requires many sessions and can be uncomfortable or risky for people with certain lung or ear conditions.

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

30 people

The number who actually took part.

Started

Dec 2014

Finished

Nov 2017

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

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: * Females * Age over 18 * Known fibromyalgia (chronic pain syndrome) for more than 1 year Exclusion Criteria: * Any past hyperbaric treatment prior to inclusion * Patients with chest x-ray pathology incompatible with hyperbaric environment * Patients with middle ear problems * Patients, who cannot "pump", equals middle ear pressure, effectively * Patients who suffer from claustrophobia * Inability or Refusing to sign the Informed Consent Form

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Conditions

The condition(s) this trial relates to.

chronic pain syndrome fibromyalgia

As listed by the trial registrant

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

Chronic pain syndrome Fibromyalgia

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.