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

Fibromyalgia Clinical Trial

— HBOTCSA  

Official title:

The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376269
• Other study ID #: 202/14
• 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
• 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

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Fibromyalgia
• Myofascial Pain Syndromes
• Psychological Trauma
• Somatoform Disorders
• Syndrome

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