Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT04316702
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2020-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Study Overview
Official Title:
Hyperbaric Oxygen Therapy vs. Pharmaceutical Therapy in Patients Suffering From Fibromyalgia That Was Induced by Emotional Trauma: Prospective, Randomized, Two Active Arms Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: