Status:
COMPLETED
Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Fibromyalgia
Hyperbaric Oxygen
Eligibility:
All Genders
18+ years
Phase:
NA
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. Th...
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 t...
Eligibility Criteria
Inclusion
- FMS diagnosis, based on the updated 2016 diagnostic criteria
- previous physical trauma (such as traumatic brain injury)
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03325959
Start Date
March 1 2017
End Date
June 1 2022
Last Update
July 3 2024
Active Locations (1)
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1
Assaf-Harofeh Medical Center
Ẕerifin, Israel, 70300