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NCT Number: NCT03376269

HBOT Effect on Chronic Pain Syndrome 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.

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Key information

Conditions

Fibromyalgia Chronic Pain Syndrome Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBOT

Biological

•HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments

Psychotherapy

Behavioral

creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions

Primary outcomes

  1. Pain sensitivity

    Time frame: Change After 3 months

    Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)

  2. 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

  3. 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.

Secondary outcomes

  1. Fibromyalgia Impact on quality of life

    Time frame: Change after 3 months

    Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100)

  2. Short form health survey (sf-36)

    Time frame: Change after 3 months

    Quality of live will be evaluated by Quality of Life RAND Short form 36 questionnaire (SF36).(scale 0-100) higher score means better outcome.

  3. Stress

    Time frame: Change after 3 months t

    Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51)

  4. Psychological symptoms

    Time frame: Change after 3 months

    Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20)

  5. Sensory symptoms

    Time frame: Change after 3 months

    Sensory symptoms will be evaluated using the Sensory Profile questionnaires .

  6. Somatoform Dissociation Questionnaire (SDQ-20)

    Time frame: Change after 3 months

    Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20).

  7. Childhood trauma psychological effects

    Time frame: Change after 3 months

    Childhood trauma psychological effects will be evaluated using the Childhood Trauma Questionnaire (CTQ) questionnaires.(scale 0-125)

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma

Acronym: HBOTCSA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2017
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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