Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma

NCT04316702 | Completed

• 1 other identifier: 0008-20
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Fibromyalgia; Emotional Trauma

Outcome Measures

Primary Outcomes (2)

• Fibromyalgia Impact Questionnaire (FIQ) questionnaire

  Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of treatment period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome

  at 3 months

• Fibromyalgia Impact Questionnaire (FIQ) questionnaire

  Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of follow up period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome

  at 6 months

Secondary Outcomes (24)

• Widespread pain index questionnaire

  at baseline, 3 months, 6 months

• Symptoms severity scale questionnaire

  at baseline, 3 months, 6 months

• Post traumatic stress disorder (PTSD) symptoms scale (PSS) questionnaire

  at baseline, 3 months, 6 months

• Medical somatic dissociation questionnaire (MSDQ)

  at baseline, 3 months, 6 months

• Recovery promoting relationships scale (RPRS)

  at baseline, 3 months, 6 months

Study Arms (2)

Hyperbaric Oxygen

ACTIVE COMPARATOR

60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes

Device: Hyperbaric oxygen therapy (HBOT) treatment

Pharmacotherapy

ACTIVE COMPARATOR

Two medications currently licensed for the treatment of FM in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 2 weeks, patients will be evaluated and dose will be adjusted as necessary and tolerated, up to the maximum dosage recommended for FM. Patients may also be switched from one medication to the other according to clinical judgment of the physician.

Drug: Cymbalta / Lyrica - Drug treatment

Interventions

Hyperbaric oxygen therapy (HBOT) treatment DEVICE

60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes

Hyperbaric Oxygen

Cymbalta / Lyrica - Drug treatment DRUG

one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Two medications currently licensed for the treatment of FM in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning).

Pharmacotherapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• The Emili Sagol Creative Arts Therapies Research Center: collaborator

Study Sites (1)

hyperbaric center Asaf harofe medical center

Rishon LeZiyyon, Israel

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Hyperbaric Oxygenation; Therapeutics; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shai a Efrati, MD

  Asaf-Harofhe MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomization by computer, the patient and her primary care physician will know the treatment received. Any side effects during therapy will be reported to the care providers and nurses and physicians unrelated to the study. Investigators and outcome assessors will not know the patient's arm.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Sagol center for hyperbaric medicine and research

Model Details: randomized controlled trial using conventional pharmacotherapy treatment compared to hyperbaric oxygen therapy

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 20, 2020
• Study Start: March 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)