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

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Chronic Pain Syndrome
• Intervention / Treatment: Biological: HBOT; Behavioral: Psychotherapy

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zerifin, Israel, 70300
    • Assaf-Harofeh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Combined HBOT/psychotherapy; combined concurrent intervention of HBOT and creative art psychotherapy.	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
Other: psychotherapy; single intervention with creative art psychotherapy	Behavioral: Psychotherapy; creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain sensitivity	Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)	Change After 3 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibromyalgia Impact on quality of life	Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100)	Change after 3 months
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
Stress	Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51)	Change after 3 months t
Psychological symptoms	Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20)	Change after 3 months
Sensory symptoms	Sensory symptoms will be evaluated using the Sensory Profile questionnaires .	Change after 3 months
Somatoform Dissociation Questionnaire (SDQ-20)	Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20).	Change after 3 months
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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: more than 1 year
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Syndrome; Chronic Pain; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes; Psychological Trauma
• Other Study ID Numbers: 202/14