Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma

NACompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 1, 2020

Primary Completion Date

November 30, 2023

Study Completion Date

November 30, 2023

Conditions
FibromyalgiaEmotional Trauma
Interventions
DEVICE

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

DRUG

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).

Trial Locations (1)

Unknown

hyperbaric center Asaf harofe medical center, Rishon LeZiyyon

All Listed Sponsors
collaborator

The Emili Sagol Creative Arts Therapies Research Center

UNKNOWN

lead

Assaf-Harofeh Medical Center

OTHER_GOV

NCT04316702 - Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma | Biotech Hunter | Biotech Hunter