Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial

NCT ID: NCT01827683

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-12-31

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).

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hyperbaric oxygen therapy group

hyperbaric oxygen therapy during the first 2 months

Group Type: ACTIVE_COMPARATOR

Hyperbaric oxygen

Intervention Type: OTHER

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

Crossed group

no active intervention during the first 2 months.After 2 months will be crossed to HBOT

Group Type: OTHER

Hyperbaric oxygen

Intervention Type: OTHER

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

Interventions

Hyperbaric oxygen

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Judith Ben Zvi

medical center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hyperbaric unit, Assaf- Harofe Medical Center

Ẕerifin, Zerifin, Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 26010952 (View on PubMed)

Other Identifiers

HBOT-Fibro

Identifier Type: -

Identifier Source: org_study_id