Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Hyperbaric oxygen

• Registration Number: NCT01827683
• Lead Sponsor: Assaf-Harofeh Medical Center

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).

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-04-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-08
• Last Update Submitted: 2013-04-08
• Study First Posted: 2013-04-09
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hyperbaric oxygen therapy group	Hyperbaric oxygen	hyperbaric oxygen therapy during the first 2 months
Crossed group	Hyperbaric oxygen	no active intervention during the first 2 months.After 2 months will be crossed to HBOT

Primary Outcome Measures

Name	Time	Method
Pain evaluation	up to 4 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life	0,2,4 months
Brain SPECT scan	0,2,4 months

Trial Locations

Locations (1)

Hyperbaric unit, Assaf- Harofe Medical Center; 🇮🇱 Zerifin, Israel