Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma

NCT ID: NCT04316702

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-11-30

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).

Detailed Description

The study will include 60 fibromyalgia patients in whom emotional trauma, such as childhood abuse, could be considered as the trigger for FMS. Each participant will be examined at the time of recruitment and a diagnosis of FMS will be verified, based on the updated 2016 diagnostic criteria. In the current study the investigators will recruit patients not currently being treated with the target medications (Lyrica or Cymbalta).

Patients will undergo randomization upon recruitment to one of the two study groups. One group will proceed to a course of HBOT treatment while the second group will commence with standard treatment for FMS, as outlined in the Israeli guidelines for the diagnosis and treatment of FMS .

HBOT protocol: a total of 60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. 60 sessions will include exposure of 90 minutes to 100% at 2 Absolute atmospheres (ATA), with 5 minutes air breaks every 20 minutes.

Pharmaceutical protocol: 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 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.

Conditions

Fibromyalgia; Emotional Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hyperbaric Oxygen

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

Group Type: ACTIVE_COMPARATOR

Hyperbaric oxygen therapy (HBOT) treatment

Intervention Type: 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

Pharmacotherapy

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.

Group Type: ACTIVE_COMPARATOR

Cymbalta / Lyrica - Drug treatment

Intervention Type: 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).

Interventions

Hyperbaric oxygen therapy (HBOT) treatment

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

Intervention Type: DEVICE

Cymbalta / Lyrica - Drug treatment

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).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Emili Sagol Creative Arts Therapies Research Center

UNKNOWN

Sponsor Role: collaborator

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Shay Efrati

Head of Sagol center for hyperbaric medicine and research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shai a Efrati, MD

Role: PRINCIPAL_INVESTIGATOR

Asaf-Harofhe MC

Locations

hyperbaric center Asaf harofe medical center

Rishon LeZiyyon, , Israel

Countries

Israel

Other Identifiers

ASF-20-0008

Identifier Type: -

Identifier Source: org_study_id