Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients suffering from chronic pain syndrome (Fibromyalgia).
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric oxygen therapy group | Active Comparator | hyperbaric oxygen therapy during the first 2 months |
|
| Crossed group | Other | no active intervention during the first 2 months.After 2 months will be crossed to HBOT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen | Other | 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain evaluation | up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | 0,2,4 months | |
| Brain SPECT scan | 0,2,4 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyperbaric unit, Assaf- Harofe Medical Center | Ẕerifin | Zerifin | 70300 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26010952 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009422 |
| Nervous System Diseases |