FibromyalgiaHBOTCSANCT03376269
HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma
A study testing HBOT and Psychotherapy in people with Fibromyalgia and Chronic Pain Syndrome, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on 2 types of patients' population suffering from chronic pain syndrome (Fibromyalgia): patients with history of psychological trauma and patients with history of traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia, Chronic Pain Syndrome
- What is being tested?
- HBOT and Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females
- Age over 18
- Known fibromyalgia (chronic pain syndrome) for more than 1 year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma
The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on 2 types of patients' population suffering from chronic pain syndrome (Fibromyalgia): patients with history of psychological trauma and patients with history of traumatic brain injury.
Read the detailed description
This study is a prospective clinical trial. After signing a written informed consent, all patients will be invited to medical evaluation including pain sensitivity examination and a series of questionnaires. In addition, all patients will have chest X-ray, cognitive evaluation, brain MRI and brain Single-photon emission computed tomography (SPECT)
. A second brain MRI, brain SPECT, pain sensitivity evaluation and questionnaires will be done after 3 months of treatment (60 sessions of HBOT). The HBOT procedure will be performed at the Sagol center for hyperbaric medicine and research of Assaf Harofeh Medical Center, Israel.
The following HBOT protocol will be applied for all patients: 12 weeks, 5 times per week, daily administration of 100% O2 for 90 minutes at a pressure of 2 absolute atmospheres (ATA) including 5 minutes air breaks every 30 minutes.
Patients with history of psychological trauma are also being treated with creative art psychotherapy. These patients will be randomly assigned to one of the two groups: (1) single intervention with creative art psychotherapy (psychotherapy group); (2) combined concurrent intervention of HBOT and creative art psychotherapy. Groups 1 will serve as controls during the first 3 months and then will be crossed to get HBOT. Before the cross to the HBOT they will have 2nd full evaluation (questioners and brain imaging).
- Conditions
- Fibromyalgia, Chronic Pain Syndrome
- Being tested
- HBOT, Psychotherapy
- Keywords
- more than 1 year
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOTBiological
•HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments
PsychotherapyBehavioural
creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions
| Study group | Role | What they receive |
|---|---|---|
| Combined HBOT/psychotherapy | Active comparator | combined concurrent intervention of HBOT and creative art psychotherapy. Receives: Biological: HBOT; Behavioral: Psychotherapy |
| psychotherapy | Other | single intervention with creative art psychotherapy Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensitivity
Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)
Measured: Change After 3 months
Brain microstructure
MRI dynamic tensor imaging sequence will be performed (DTI). Fractional anisotropy (FA) values will be assessed at base line and at 3 months. The changes at 3 months from baseline will be compared
Measured: Change after 3 months
Brain Metabolism
Brain metabolism will be assessed using SPECT at baseline, 3 monthsThe counts for each different Broadmann area values will be calculated. The changes at 3 months from baseline will be compared.
Measured: Change after 3 months
Secondary outcomes (7)
Fibromyalgia Impact on quality of life
Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100)
Measured: Change after 3 months
Short form health survey (sf-36)
Quality of live will be evaluated by Quality of Life RAND Short form 36 questionnaire (SF36).(scale 0-100) higher score means better outcome.
Measured: Change after 3 months
Stress
Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51)
Measured: Change after 3 months t
Psychological symptoms
Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20)
Measured: Change after 3 months
Sensory symptoms
Sensory symptoms will be evaluated using the Sensory Profile questionnaires .
Measured: Change after 3 months
Somatoform Dissociation Questionnaire (SDQ-20)
Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20).
Measured: Change after 3 months
Childhood trauma psychological effects
Childhood trauma psychological effects will be evaluated using the Childhood Trauma Questionnaire (CTQ) questionnaires.(scale 0-125)
Measured: Change after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study startDec 2014
- Primary completionJun 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Efrati, Assaf-Harofeh Medical Center
- Investigators
- Shai a Efrati, MD, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376269
- Sponsor's protocol ID
- 0202-14
- Acronym
- HBOTCSA
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2015
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Hadanny A, Bechor Y, Catalogna M, Daphna-Tekoah S, Sigal T, Cohenpour M, Lev-Wiesel R, Efrati S. Hyperbaric Oxygen Therapy Can Induce Neuroplasticity and Significant Clinical Improvement in Patients Suffering From Fibromyalgia With a History of Childhood Sexual Abuse-Randomized Controlled Trial. Front Psychol. 2018 Dec 17;9:2495. doi: 10.3389/fpsyg.2018.02495. eCollection 2018.
PubMed 30618929
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma
- ClinicalTrials.gov ID
- NCT03376269
- Acronym / sponsor ID
- HBOTCSA / 0202-14
- Conditions
- Fibromyalgia, Chronic Pain Syndrome
- Keywords
- more than 1 year
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on 2 types of patients' population suffering from chronic pain syndrome (Fibromyalgia): patients with history of psychological trauma and patients with history of traumatic brain injury.
Detailed description
This study is a prospective clinical trial. After signing a written informed consent, all patients will be invited to medical evaluation including pain sensitivity examination and a series of questionnaires. In addition, all patients will have chest X-ray, cognitive evaluation, brain MRI and brain Single-photon emission computed tomography (SPECT)
. A second brain MRI, brain SPECT, pain sensitivity evaluation and questionnaires will be done after 3 months of treatment (60 sessions of HBOT). The HBOT procedure will be performed at the Sagol center for hyperbaric medicine and research of Assaf Harofeh Medical Center, Israel.
The following HBOT protocol will be applied for all patients: 12 weeks, 5 times per week, daily administration of 100% O2 for 90 minutes at a pressure of 2 absolute atmospheres (ATA) including 5 minutes air breaks every 30 minutes.
Patients with history of psychological trauma are also being treated with creative art psychotherapy. These patients will be randomly assigned to one of the two groups: (1) single intervention with creative art psychotherapy (psychotherapy group); (2) combined concurrent intervention of HBOT and creative art psychotherapy. Groups 1 will serve as controls during the first 3 months and then will be crossed to get HBOT. Before the cross to the HBOT they will have 2nd full evaluation (questioners and brain imaging).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined HBOT/psychotherapy | Active comparator | Biological: HBOT, Behavioral: Psychotherapycombined concurrent intervention of HBOT and creative art psychotherapy. |
| psychotherapy | Other | Behavioral: Psychotherapysingle intervention with creative art psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females
- Age over 18
- Known fibromyalgia (chronic pain syndrome) for more than 1 year
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBOT•HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments | Biological | Combined HBOT/psychotherapy |
| Psychotherapycreative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions | Behavioural | Combined HBOT/psychotherapy, psychotherapy |
Primary outcome
Pain sensitivity
Time frame: Change After 3 months
Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)
Brain microstructure
Time frame: Change after 3 months
MRI dynamic tensor imaging sequence will be performed (DTI). Fractional anisotropy (FA) values will be assessed at base line and at 3 months. The changes at 3 months from baseline will be compared
Brain Metabolism
Time frame: Change after 3 months
Brain metabolism will be assessed using SPECT at baseline, 3 monthsThe counts for each different Broadmann area values will be calculated. The changes at 3 months from baseline will be compared.
7 secondary outcomes
Fibromyalgia Impact on quality of life
Time frame: Change after 3 months
Short form health survey (sf-36)
Time frame: Change after 3 months
Stress
Time frame: Change after 3 months t
Psychological symptoms
Time frame: Change after 3 months
Sensory symptoms
Time frame: Change after 3 months
Somatoform Dissociation Questionnaire (SDQ-20)
Time frame: Change after 3 months
Childhood trauma psychological effects
Time frame: Change after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 30618929Hadanny A, Bechor Y, Catalogna M, Daphna-Tekoah S, Sigal T, Cohenpour M, Lev-Wiesel R, Efrati S. Hyperbaric Oxygen Therapy Can Induce Neuroplasticity and Significant Clinical Improvement in Patients Suffering From Fibromyalgia With a History of Childhood Sexual Abuse-Randomized Controlled Trial. Front Psychol. 2018 Dec 17;9:2495. doi: 10.3389/fpsyg.2018.02495. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shai a Efrati, MD principal investigator
Asaf-Harofhe MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBOT and Psychotherapy in people with Fibromyalgia and Chronic Pain Syndrome, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain sensitivity (time frame: Change After 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.