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

Shamir Medical Center (Assaf-Harofeh)

Status: Completed

Conditions: Fibromyalgia; Chronic Pain Syndrome

Treatments: Behavioral: Psychotherapy; Biological: HBOT

Study type: Interventional

Funder types: Other

Identifiers

NCT03376269

202/14

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Combined HBOT/psychotherapy

Active Comparator group

Description:

combined concurrent intervention of HBOT and creative art psychotherapy.

Treatment:

Biological: HBOT

Behavioral: Psychotherapy

psychotherapy

Other group

Description:

single intervention with creative art psychotherapy

Treatment:

Behavioral: Psychotherapy