Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827683
• Other study ID #: HBOT-Fibro
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: April 8, 2013
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients suffering from chronic pain syndrome (Fibromyalgia).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Hyperbaric oxygen
8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.

Locations

Country	Name	City	State
Israel	Hyperbaric unit, Assaf- Harofe Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain evaluation		up to 4 months	No
Secondary	Quality of Life		0,2,4 months	No
Secondary	Brain SPECT scan		0,2,4 months	No