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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 6, 2015
First Posted Date  ICMJE December 18, 2017
Last Update Posted Date December 18, 2017
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
  • Fibromyalgia Impact on quality of life [ Time Frame: Change after 3 months ]
    Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100)
  • 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)
  • Stress [ Time Frame: Change after 3 months t ]
    Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51)
  • Psychological symptoms [ Time Frame: Change after 3 months ]
    Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20)
  • Sensory symptoms [ Time Frame: Change after 3 months ]
    Sensory symptoms will be evaluated using the Sensory Profile questionnaires .
  • Somatoform Dissociation Questionnaire (SDQ‐20) [ Time Frame: Change after 3 months ]
    Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ‐20).
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma
Official Title  ICMJE The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fibromyalgia
  • Chronic Pain Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Combined HBOT/psychotherapy
    combined concurrent intervention of HBOT and creative art psychotherapy.
    Interventions:
    • Biological: HBOT
    • Behavioral: Psychotherapy
  • psychotherapy
    single intervention with creative art psychotherapy
    Intervention: Behavioral: Psychotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2017)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03376269
Other Study ID Numbers  ICMJE 202/14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Shay Efrati, Assaf-Harofeh Medical Center
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assaf-Harofeh Medical Center
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP