Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with significant improvement in life quality; furthermore, the investigators were able to demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the hyperactivity in posterior regions and elevation of the reduced activity in frontal areas.

In this study, the investigators intend to both repeat and expand the investigator's previous findings, treating FMS patients with history of emotional trauma with HBOT, while performing an extensive of evaluation both before and after treatment.

In the current study, the investigators plan to compare HBOT to current standard of care of FMS (pharmacological and non - pharmacological).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assaf-Harofeh Medical Center
• Collaborator: The Emili Sagol Creative Arts Therapies Research Center
• Treatments: Duloxetine Hydrochloride; Pregabalin

Criteria

Inclusion Criteria:

• FM diagnosis based on the widespread pain index (WPI) and the Symptom Severity Score (SSS).

• Score at the trauma questionnaire indicating low, moderate or severe trauma in one of the criteria specified in the questionnaire.

• Ability to provide informed consent

• Age>18

Exclusion Criteria:

• Presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.

• History of traumatic brain injury (TBI)

• Other FM etiologies

• Currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica)

• Contraindications to both Lyrica and Cymbalta

• Major psychiatric disorder (such as major depression, schizophrenia, bi-polar disorder)

• Previous suicidal attempt/s

• Does not take part in psychotherapy on a weekly basis (minimum)

• Previous HBOT for any other reason prior to their inclusion

• Chest pathology (including active asthma)

• Inner ear disease

• Claustrophobia

• Inability to perform awake brain MRI test

• Chronic renal failure (eGFR< 60 ml/min)

• Previous neurological conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.); Brain tumors; Skull base fractures; Active malignancy; s/p neurosurgery

• Active Smoking

• Pregnancy or not committing to not getting pregnant during the study period