Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome

NCT ID: NCT03325959

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2022-06-01

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).

Detailed Description

The study will include 70 fibromyalgia patients in whom physical trauma, such mild traumatic brain injury (mTBI), 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 medications specific for FMS, including anti-depression drugs, gabapentanoids and tricyclics, opiods and medical cannabis. Patients who are on such treatment will be required to discontinue treatment 2 weeks before recruitment.

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 [41]. These patients will be given detailed education regarding the nature of FMS as well as recommendations regarding non - pharmacological interventions recommended for FMS, including graded physical exercise, hydrotherapy, movement-meditative treatments (e.g. Tai Chi) and cognitive behavioral treatment (CBT).

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 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.

Conditions

Fibromyalgia; Hyperbaric Oxygen

Study Design

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

Study Groups

Hyperbaric oxygen therapy

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.

Group Type: ACTIVE_COMPARATOR

Hyperbaric oxygen therapy (HBOT) treatment

Intervention Type: DEVICE

60 HBOT sessions at 2 ATA 100% oxygen

Pharmacotherapy

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.

Group Type: ACTIVE_COMPARATOR

Cymbalta / Lyrica treatment

Intervention Type: DRUG

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

Crossover Hyperbaric oxygen therapy

Intervention Type: DEVICE

60 HBOT sessions at 2 ATA 100% oxygen after crossover

Interventions

Hyperbaric oxygen therapy (HBOT) treatment

60 HBOT sessions at 2 ATA 100% oxygen

Intervention Type: DEVICE

Cymbalta / Lyrica treatment

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

Intervention Type: DRUG

Crossover Hyperbaric oxygen therapy

60 HBOT sessions at 2 ATA 100% oxygen after crossover

Intervention Type: DEVICE

Other Intervention Names

Cymbalta / Lyrica

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• previous HBOT for any other reason prior to their inclusion;
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shai a Efrati, MD

Role: PRINCIPAL_INVESTIGATOR

Asaf-Harofhe MC

Locations

Assaf-Harofeh Medical Center

Ẕerifin, , Israel

Countries

Israel

Other Identifiers

0058-17-ASF

Identifier Type: -

Identifier Source: org_study_id