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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-11-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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Fibromyalgia Chronic Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Combined HBOT/psychotherapy

combined concurrent intervention of HBOT and creative art psychotherapy.

Group Type ACTIVE_COMPARATOR

HBOT

Intervention Type BIOLOGICAL

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

Psychotherapy

Intervention Type BEHAVIORAL

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

psychotherapy

single intervention with creative art psychotherapy

Group Type OTHER

Psychotherapy

Intervention Type BEHAVIORAL

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

Interventions

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HBOT

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

Intervention Type BIOLOGICAL

Psychotherapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No