NCT03376269

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Fibromyalgia
• Chronic Pain Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-06-01
• Completion: 2017-11-01
• First posted: 2017-12-18
• Last updated: 2024-07-03

Locations

1 site across 1 country: Israel