Status:
COMPLETED
The Effect of Epiduroscopy and Ozone Therapy in Patients With Failed Back Surgery Syndrome
Lead Sponsor:
University of Sao Paulo
Conditions:
Low Back Pain
Failed Back Surgery Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The aim of this study is to assess the efficacy and safety of ozone therapy (vs. placebo) applied into the epidural space through epiduroscopy in Patients with Failed Back Surgery Syndrome. It´s a Pro...
Detailed Description
Although surgical discectomy for disc herniation produces better short-term pain relief than conservative therapy, there is no convincing evidence for the long-term (10 years) advantage of surgery. Be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01172457
Start Date
May 1 2009
End Date
July 1 2012
Last Update
August 30 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of São Paulo Medical School
São Paulo, São Paulo, Brazil, 01060-970