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HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma (HBOTCSA)

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ClinicalTrials.gov Identifier: NCT03376269
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Shay Efrati, Assaf-Harofeh Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Pain Syndrome Biological: HBOT Behavioral: Psychotherapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma
Actual Study Start Date : December 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Combined HBOT/psychotherapy
combined concurrent intervention of HBOT and creative art psychotherapy.
Biological: HBOT
•HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments

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

psychotherapy
single intervention with creative art psychotherapy
Behavioral: Psychotherapy
creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions




Primary Outcome Measures :
  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 Outcome Measures :
  1. Fibromyalgia Impact on quality of life [ Time Frame: Change after 3 months ]
    Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100)

  2. Quality of Life [ Time Frame: Change after 3 months ]
    Quality of live will be evaluated by Quality of Life RAND hort form 36 questionnaire (SF36).(scale 0-100)

  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376269


Locations
Israel
Assaf-Harofeh Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Responsible Party: Prof. Shay Efrati, Director of Sagol Center for Hyperbaric medicine and Research, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT03376269     History of Changes
Other Study ID Numbers: 202/14
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Keywords provided by Prof. Shay Efrati, Assaf-Harofeh Medical Center:
more than 1 year

Additional relevant MeSH terms:
Syndrome
Chronic Pain
Fibromyalgia
Myofascial Pain Syndromes
Somatoform Disorders
Psychological Trauma
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders