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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03376269
Other study ID # 202/14
Secondary ID
Status Completed
Phase N/A
First received April 6, 2015
Last updated December 13, 2017
Start date December 2014
Est. completion date November 2017

Study information

Verified date December 2017
Source Assaf-Harofeh Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Israel Assaf-Harofeh Medical Center Zerifin

Sponsors (1)

Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain sensitivity Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18) Change After 3 months
Primary 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 Change after 3 months
Primary 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. Change after 3 months
Secondary Fibromyalgia Impact on quality of life Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100) Change after 3 months
Secondary Quality of Life Quality of live will be evaluated by Quality of Life RAND hort form 36 questionnaire (SF36).(scale 0-100) Change after 3 months
Secondary Stress Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51) Change after 3 months t
Secondary Psychological symptoms Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20) Change after 3 months
Secondary Sensory symptoms Sensory symptoms will be evaluated using the Sensory Profile questionnaires . Change after 3 months
Secondary Somatoform Dissociation Questionnaire (SDQ-20) Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20). Change after 3 months
Secondary Childhood trauma psychological effects Childhood trauma psychological effects will be evaluated using the Childhood Trauma Questionnaire (CTQ) questionnaires.(scale 0-125) Change after 3 months
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