Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome

NCT03325959 | Completed

• 1 other identifier: 0058-17-ASF
• Study Type: interventional
• Target: 76
• 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 the proposed study, the investigators intend to both repeat and expand our previous findings, treating FMS patients 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; Hyperbaric Oxygen

Keywords

hyperbaric oxygen; HBOT; fibromyalgia; pain

Outcome Measures

Primary Outcomes (2)

• Visual analogue Scale (VAS)

  The primary end point of the study will be the measurement of daily pain on a (0-10) Visual analogue Scale

  at 3 months

• Visual analogue Scale (VAS)

  The primary end point of the study will be the measurement of daily pain on a (0-10 scale) Visual analogue Scale

  at 6 months

Secondary Outcomes (30)

• Global Pain Scale (GPS)

  baseline, at 3 months, at 6 months

• Patient global impression of change

  baseline, at 3 months, at 6 months

• Fibromyalgia Impact Questionnaire

  baseline, at 3 months, at 6 months

• Wide Spread Pain Index

  baseline, at 3 months, at 6 months

• Symptom Severity Scale

  baseline, at 3 months, at 6 months

Study Arms (2)

Hyperbaric oxygen therapy

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 Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group.

Device: Hyperbaric oxygen therapy (HBOT) treatment

Pharmacotherapy

ACTIVE COMPARATOR

patients will be offered pharmacological treatment with one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg at bedtime while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 6 weeks patients will be evaluated and dose will be adjusted as necessary. Patients may also be switched from one medication to the other based according to clinical judgment. Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group.

Drug: Cymbalta / Lyrica treatment; Device: Crossover Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapy (HBOT) treatment DEVICE

60 HBOT sessions at 2 ATA 100% oxygen

Hyperbaric oxygen therapy

Cymbalta / Lyrica treatment DRUG

one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica.

Also known as: Cymbalta / Lyrica

Pharmacotherapy

Crossover Hyperbaric oxygen therapy DEVICE

60 HBOT sessions at 2 ATA 100% oxygen after crossover

Pharmacotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FMS diagnosis, based on the updated 2016 diagnostic criteria
• previous physical trauma (such as traumatic brain injury)

You may not qualify if:

• the presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.
• active malignancy,
• chronic ongoing infection
• major psychiatric disorders (excluding anxiety)
• Patients currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica) will also be excluded
• Chest pathology incompatible with pressure changes (including active asthma);
• Inner ear disease
• Claustrophobia;
• Inability to perform awake brain MRI test;
• Previous neurologic conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.);
• Brain tumors;
• Skull base fractures;
• s/p neurosurgery that included: ventricular drainage, subdural hematomas drainage, epidural hematomas drainage, intracerebral hemorrhage evacuation. Depressed fracture surgery, (Patients suffering from Encephalomalacia per MRI imaging will not be excluded).
• Inability to provide informed consent

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Hyperbaric Oxygenation; Therapeutics; Duloxetine Hydrochloride; Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

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: Prof.

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

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 30, 2017
• Study Start: March 1, 2017
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)