Hyperbaric Oxygen Therapy vs. Pharmaceutical Therapy in Patients Suffering From Fibromyalgia That Was Induced by Emotional Trauma: Prospective, Randomized, Two Active Arms Clinical Trial
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.
Condition:
Fibromyalgia
Treatment:
Hyperbaric oxygen therapy
Start Date:
March 2020
Sponsor:
Assaf-Harofeh Medical Center
For More Information:
https://clinicaltrials.gov/show/NCT04316702