Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial
The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia)
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients suffering from chronic pain syndrome (Fibromyalgia).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedApril 9, 2013
April 1, 2013
2.6 years
April 6, 2011
April 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain evaluation
up to 4 months
Secondary Outcomes (2)
Quality of Life
0,2,4 months
Brain SPECT scan
0,2,4 months
Study Arms (2)
Hyperbaric oxygen therapy group
ACTIVE COMPARATORhyperbaric oxygen therapy during the first 2 months
Crossed group
OTHERno active intervention during the first 2 months.After 2 months will be crossed to HBOT
Interventions
8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
Eligibility Criteria
You may qualify if:
- fibromyalgia diagnosed by physical examination of pain sensitivity, by Dolorimeter and finger pressure.
You may not qualify if:
- any past hyperbaric oxygen therapy
- chest x-ray pathology which does not allow the income into the hyperbaric chamber.
- middle ear problems.
- patients, who cannot "pump", equals middle ear pressure, effectively.
- patients who suffer from claustrophobia.
- inability or Refusing to sign the Informed Consent Form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hyperbaric unit, Assaf- Harofe Medical Center
Ẕerifin, Zerifin, 70300, Israel
Related Publications (1)
Efrati S, Golan H, Bechor Y, Faran Y, Daphna-Tekoah S, Sekler G, Fishlev G, Ablin JN, Bergan J, Volkov O, Friedman M, Ben-Jacob E, Buskila D. Hyperbaric oxygen therapy can diminish fibromyalgia syndrome--prospective clinical trial. PLoS One. 2015 May 26;10(5):e0127012. doi: 10.1371/journal.pone.0127012. eCollection 2015.
PMID: 26010952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical center
Study Record Dates
First Submitted
April 6, 2011
First Posted
April 9, 2013
Study Start
May 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
April 9, 2013
Record last verified: 2013-04