Skip to main content
Clinical Trials/NCT01827683
NCT01827683
Completed
Not Applicable

The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia)

Assaf-Harofeh Medical Center1 site in 1 country60 target enrollmentMay 2010
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Assaf-Harofeh Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Pain evaluation
Status
Completed
Last Updated
13 years ago

Overview

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).

Detailed Description

The study is a prospective, randomized, cross-over trial. Patients will be randomized into two groups (test and control) to receive the HBOT at the beginning of the trial or 2 months afterwards. The control group will receive its treatment after the elapsed two months. This study will be a prospective, randomized cross over study. After signing a written informed consent, all patients will be invited to a 2 hour examination, including pain sensitivity examination and a series of questionnaires. In addition, prior to the beginning of the treatment all patients will have chest X-ray, neurological examination, cognitive evaluation and brain metabolism evaluation (SPECT scan). A similar evaluation will be done after the 8 weeks, test versus control time period, and another evaluation will be held after 16 weeks. The HBOT procedure will be performed in the hyperbaric chamber at Assaf Harofeh Medical Center, Israel. The following HBOT protocol will be applied for the treated group: 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA. After 8 weeks the control group, that did not received HBOT, will receive the same HBOT protocols. At baseline, after 2 months and after 4 months all patients will undergo complete neurologic and pain evaluation and brain SPECT scan (total of 3 evaluation and scan per patient).

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Judith Ben Zvi

medical center

Assaf-Harofeh Medical Center

Eligibility Criteria

Inclusion Criteria

  • fibromyalgia diagnosed by physical examination of pain sensitivity, by Dolorimeter and finger pressure.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Pain evaluation

Time Frame: up to 4 months

Secondary Outcomes

  • Quality of Life(0,2,4 months)
  • Brain SPECT scan(0,2,4 months)

Study Sites (1)

Loading locations...

Similar Trials