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

Primary Purpose

Fibromyalgia, Chronic Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
HBOT
Psychotherapy
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring more than 1 year

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assaf-Harofeh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Combined HBOT/psychotherapy

psychotherapy

Arm Description

combined concurrent intervention of HBOT and creative art psychotherapy.

single intervention with creative art psychotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fibromyalgia Impact on quality of life
Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100)
Quality of Life
Quality of live will be evaluated by Quality of Life RAND hort form 36 questionnaire (SF36).(scale 0-100)
Stress
Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51)
Psychological symptoms
Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20)
Sensory symptoms
Sensory symptoms will be evaluated using the Sensory Profile questionnaires .
Somatoform Dissociation Questionnaire (SDQ-20)
Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20).
Childhood trauma psychological effects
Childhood trauma psychological effects will be evaluated using the Childhood Trauma Questionnaire (CTQ) questionnaires.(scale 0-125)

Full Information

First Posted
April 6, 2015
Last Updated
December 13, 2017
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03376269
Brief Title
HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma
Acronym
HBOTCSA
Official Title
The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Pain Syndrome
Keywords
more than 1 year

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined HBOT/psychotherapy
Arm Type
Active Comparator
Arm Description
combined concurrent intervention of HBOT and creative art psychotherapy.
Arm Title
psychotherapy
Arm Type
Other
Arm Description
single intervention with creative art psychotherapy
Intervention Type
Biological
Intervention Name(s)
HBOT
Intervention Description
•HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions
Primary Outcome Measure Information:
Title
Pain sensitivity
Description
Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)
Time Frame
Change After 3 months
Title
Brain microstructure
Description
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
Time Frame
Change after 3 months
Title
Brain Metabolism
Description
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.
Time Frame
Change after 3 months
Secondary Outcome Measure Information:
Title
Fibromyalgia Impact on quality of life
Description
Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100)
Time Frame
Change after 3 months
Title
Quality of Life
Description
Quality of live will be evaluated by Quality of Life RAND hort form 36 questionnaire (SF36).(scale 0-100)
Time Frame
Change after 3 months
Title
Stress
Description
Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51)
Time Frame
Change after 3 months t
Title
Psychological symptoms
Description
Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20)
Time Frame
Change after 3 months
Title
Sensory symptoms
Description
Sensory symptoms will be evaluated using the Sensory Profile questionnaires .
Time Frame
Change after 3 months
Title
Somatoform Dissociation Questionnaire (SDQ-20)
Description
Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20).
Time Frame
Change after 3 months
Title
Childhood trauma psychological effects
Description
Childhood trauma psychological effects will be evaluated using the Childhood Trauma Questionnaire (CTQ) questionnaires.(scale 0-125)
Time Frame
Change after 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Assaf-Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
30618929
Citation
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.
Results Reference
derived

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

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