Clinical trial NCT01827683: Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial
Official title: The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: hyperbaric oxygen
fibromyalgia
chronic pain syndrome
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-04-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pain evaluation
timeFrame: up to 4 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 0,2,4 months
measure: Brain SPECT scan
timeFrame: 0,2,4 months
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Hyperbaric unit, Assaf- Harofe Medical Center
Study officials:
References:
citation: 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.