The Effect of Epiduroscopy and Ozone Therapy in Patients With Failed Back Surgery Syndrome (Epiduroscopy)
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ClinicalTrials.gov Identifier: NCT01172457 |
Recruitment Status
:
Completed
First Posted
: July 29, 2010
Last Update Posted
: August 30, 2013
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Condition or disease | Intervention/treatment | Phase |
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Low Back Pain Failed Back Surgery Syndrome | Procedure: Epiduroscopy with oxygen therapy Procedure: Epiduroscopy with ozone therapy | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind Study to Evaluate the Effect of Epiduroscopy and Ozone Therapy in Patients With Failed Back Surgery Syndrome |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Epiduroscopy with ozone therapy
Patients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy.
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Procedure: Epiduroscopy with ozone therapy
Patients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy.
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Placebo Comparator: Epiduroscopy with oxygen therapy
Patients in this group will receive 30 mL of oxygen by epiduroscopy.
|
Procedure: Epiduroscopy with oxygen therapy
Patients in this group will receive 30 mL of oxygen by epiduroscopy.
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- To evaluate the efficacy of ozone versus placebo (oxygen) applied into the epidural space of patients with Failed Back Surgery Syndrome (FBSS) through epiduroscopy. [ Time Frame: up to 01 year ]The pain intensity is measured by visual analog pain scale - VAS
- To evaluate the psychological aspects. [ Time Frame: up to 01 year ]To evaluate the effects of ozone applied into the epidural space of patients with Failed Back Surgery Syndrome (FBSS) through epiduroscopy about the psychological aspects. The investigators are using the Beck Depression Inventory.
- The quality of life. [ Time Frame: up to 01 year ]To evaluate the effects of ozone applied into the epidural space of patients with chronic pain syndrome post-laminectomy through epiduroscopy about the quality of life using the WHOQOL questionaire.
- To evaluate the physical capacity [ Time Frame: up to 01 year ]To evaluate the effects of ozone applied into the epidural space of patients with chronic pain syndrome post-laminectomy through epiduroscopy about physical capacity. The investigators are using the Oswestry Disability Index.
- To evaluate the use of analgesic medications [ Time Frame: up to 01 year ]The researchers will evaluate the amount of analgesic medications used during the monitoring period.
- To evaluate the rate of side effects or complications [ Time Frame: up to 01 year ]The side effects or adverse effects will be assessed according to Common Terminology Criteria for Adverse Effect 4.0. In case of complications, will be recorded and analyzed.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Sciatic pain of 5 or more on Visual Analogue Scale
- Previous lumbar spine surgery
- More than six months into group interdisciplinary pain with pain refractory to medical treatment
- Patients with FBSS of the nonsurgical etiology
- Patients without labor dispute ort secondary gain
Exclusion Criteria:
- Inability to fill out questionnaires (VAS, Roland Morris, WHOQOL, OSWESTRY DISABILITY SCALE, f. ex.)
- Presence of other spinal pathology
- Allergy to ozone
- Treatment with oral anticoagulants
- Hyperthyroidism
- Diabetic neuropathy
- favism (Significant glucose-6-phosphate-dehydrogenase deficit)and hyperthyroidism that are contra-indications for ozone therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172457
Brazil | |
University of São Paulo Medical School | |
São Paulo, Brazil, 01060-970 |
Additional Information:
Publications of Results:
Other Publications:
Responsible Party: | Neuton Magalhaes, MD, University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT01172457 History of Changes |
Other Study ID Numbers: |
Epiduroscopy trial |
First Posted: | July 29, 2010 Key Record Dates |
Last Update Posted: | August 30, 2013 |
Last Verified: | August 2013 |
Keywords provided by Neuton Magalhaes, University of Sao Paulo:
low back pain failed back surgery syndrome (FBSS) epidural fibrosis ozone therapy |
oxygen therapy epiduroscopy spinal endoscopy |
Additional relevant MeSH terms:
Syndrome Back Pain Low Back Pain Failed Back Surgery Syndrome Disease Pathologic Processes |
Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Postoperative Complications |