Clinical trial NCT03376269: HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma
Official title: The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Pain Syndrome
Keywords: more than 1 year
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-12-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pain sensitivity
timeFrame: Change After 3 months
measure: Brain microstructure
timeFrame: Change after 3 months
measure: Brain Metabolism
timeFrame: Change after 3 months
Secondary outcomes:
measure: Fibromyalgia Impact on quality of life
timeFrame: Change after 3 months
measure: Short form health survey (sf-36)
timeFrame: Change after 3 months
measure: Stress
timeFrame: Change after 3 months t
measure: Psychological symptoms
timeFrame: Change after 3 months
measure: Sensory symptoms
timeFrame: Change after 3 months
measure: Somatoform Dissociation Questionnaire (SDQ-20)
timeFrame: Change after 3 months
measure: Childhood trauma psychological effects
timeFrame: Change after 3 months
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
affiliation: Asaf-Harofhe MC
name: Shai a Efrati, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.