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Double-blind controlled study on the effect of ozone applied for spinal endoscopy in the treatment of post-laminectomy pain syndrome: differential analysis in neuropathic and non-neuropathic pain and its correlation with the level of epidural cytokines

Grant number: 11/08529-5
Support type:Regular Research Grants
Duration: October 01, 2011 - September 30, 2013
Field of knowledge:Health Sciences - Medicine - Surgery
Principal Investigator:Erich Talamoni Fonoff
Grantee:Erich Talamoni Fonoff
Home Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
Assoc. researchers:Camila Squarzoni Dale ; Francisco Nêuton de Oliveira Magalhães ; Manoel Jacobsen Teixeira ; Rosana de Lima Pagano

Abstract

Introduction: In the last two decades, particularly in Europe, some authors have been devoted to the study of ozone as a treatment for low back pain, applied by means of minimally invasive techniques. Nevertheless, ozone therapy remains unknown to most physicians because of the lack of controlled studies. Various mechanisms have been proposed for the effects of ozone as, the analgesic, anti-inflammatory and oxidizing algiogenic substances, however no study has focused the correlation proposed mechanisms and the clinical effect of ozone. Objectives: Evaluation of the effects of ozone, compared with placebo in the pain related to failed back surgery syndrome and correlate levels of cytokines in the epidural space with clinical response to the ozone therapy. Clinical grading of pain at one year of follow up will be the primary endpoint of this study. Materials and Methods: A prospective, double-blind, randomized study. We will study 40 patients with chronic back pain after lumbar spine surgery for more than six months. Complete clinical and neurological evaluation will be performed before and after (1, 3, 6 and 12 months) the procedure, pain scales (VAS, McGill, DN4, NPSI), quality of life scale (WHOQOL), scales of disability in back pain (Roland and Morris Disability Scale Oswestry). The injection of either ozone or oxygen (placebo) in the lumbar epidural space will be made by minimal invasive spinal endoscopy through the sacral hiatus under local anesthesia and light sedation. Both the medical team and the patients will be blinded which gas will be injected. Twenty additional patients will undergo the two procedures with an interval of 30 days. Twenty additional patients will undergo two procedures as commonly performed in the literature with the interval of 4 weeks. In both procedures the epidural fluid will be collected for the dosage of cytokines and their levels will be correlated to the clinical findings. (AU)

Scientific publications (7)
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
FLORENCE, GERSON; SAMESHIMA, KOICHI; FONOFF, ERICH T.; HAMANI, CLEMENT. Deep Brain Stimulation: More Complex than the Inhibition of Cells and Excitation of Fibers. NEUROSCIENTIST, v. 22, n. 4, p. 332-345, AUG 2016. Web of Science Citations: 23.
FONOFF, ERICH TALAMONI; CONTRERAS LOPEZ, WILLIAM OMAR; ALMEIDA DE OLIVEIRA, YWZHE SIFUENTES; TEIXEIRA, MANOEL JACOBSEN. Microendoscopy-guided percutaneous cordotomy for intractable pain: case series of 24 patients. JOURNAL OF NEUROSURGERY, v. 124, n. 2, p. 389-396, FEB 2016. Web of Science Citations: 1.
VALVERDE-FILHO, JOAO; CARNEIRO DA CUNHA NETO, MALEBRANCHE BERARDO; FONOFF, ERICH TALAMONI; MEIRELLES, EDUARDO DE SOUZA; TEIXEIRA, MANOEL JACOBSEN. Chronic Spinal and Oral Morphine-Induced Neuroendocrine and Metabolic Changes in Noncancer Pain Patients. PAIN MEDICINE, v. 16, n. 4, p. 715-725, APR 2015. Web of Science Citations: 5.
FONOFF, FERNANDA COLUCCI; FONOFF, ERICH TALAMONI; BARBOSA, EGBERTO REIS; QUARANTA, THAIS; MACHADO, RACHAEL BRANT; DE ANDRADE, DANIEL CIAMPI; TEIXEIRA, MANOEL JACOBSEN; FUENTES, DANIEL. Correlation Between Impulsivity and Executive Function in Patients With Parkinson Disease Experiencing Depression and Anxiety Symptoms. JOURNAL OF GERIATRIC PSYCHIATRY AND NEUROLOGY, v. 28, n. 1, p. 49-56, MAR 2015. Web of Science Citations: 10.
DE OLIVEIRA MAGALHAES, FRANCISCO NEUTON; SOARES, SANDRA CORREIA; TORRES, JAQUELINE MELO; UNGARETTI, ARTHUR; CACCIACARRO, MARIANA FILLIPI; TEIXEIRA, MANOEL JACOBSEN; FONOFF, ERICH TALAMONI. Effects of ozone applied by spinal endoscopy in patients with chronic pain related to failed back surgery syndrome: a pilot study. NEUROPSYCHIATRIC DISEASE AND TREATMENT, v. 9, p. 1759-1766, 2013. Web of Science Citations: 11.
DE OLIVEIRA MAGALHAES, FRANCISCO N.; DOTTA, LUCIANA; SASSE, ANDRE; TEIXEIRA, MANOEL J.; FONOFF, ERICH T. Ozone Therapy as a Treatment for Low Back Pain Secondary to Herniated Disc: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician, v. 15, n. 2, p. E115-E129, MAR-APR 2012. Web of Science Citations: 52.
TEIXEIRA, MANOEL JACOBSEN; DE ALMEIDA, FABRICIO FREITAS; ALMEIDA DE OLIVEIRA, YWZHE SIFUENTES; FONOFF, ERICH TALAMONI. Microendoscopic stereotactic-guided percutaneous radiofrequency trigeminal nucleotractotomy. JOURNAL OF NEUROSURGERY, v. 116, n. 2, p. 331-335, FEB 2012. Web of Science Citations: 2.

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