The Effect of Epiduroscopy and Ozone Therapy in Patients With Failed Back Surgery Syndrome - Full Text View

Purpose

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 Prospective, double-blind, randomized study. The investigators will study 30 patients of both sexes between 18 and 70 years with chronic back pain after lumbar spine surgery for more than six months.The patients will receive the ozone gas or placebo (oxygen) in the lumbar epidural space, using a spinal endoscope inserted through the sacral hiatus by local anesthesia or sedation. The patients will be evaluated before the procedure, with 30 days, with 3, 6 and 12 months after intervention. This will be run by a researcher who will have no knowledge of the gas (oxygen or ozone) to be injected into the lumbar epidural space with the aid of an epiduroscopic. Will be applied before and after the procedure, pain scales (VAS, McGill, DN4, NPSI), quality of life scale (WHOQOL), scales of back pain disability (Roland Morris and Oswestry Disabilities Scales). Only one researcher will keep the data confidential until the end of the study.

Condition	Intervention	Phase
Low Back Pain Failed Back Surgery Syndrome	Procedure: Epiduroscopy with oxygen therapy Procedure: Epiduroscopy with ozone therapy	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Oxygen Therapy Ozone

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

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: 01 year ] [ Designated as safety issue: Yes ]
The pain intensity is measured by visual analog pain scale - VAS

Secondary Outcome Measures:

To evaluate the psychological aspects. [ Time Frame: 01 year ] [ Designated as safety issue: Yes ]
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 - BDI.
The quality of life. [ Time Frame: 01 year ] [ Designated as safety issue: Yes ]
To evaluate the effects of ozone applied into the epidural space of patients with chronic pain syndrome post-laminectomy through epiduroscopia about the quality of life using the WHOQOL questionaire.
To evaluate the physical capacity [ Time Frame: 01 year ] [ Designated as safety issue: Yes ]
To evaluate the effects of ozone applied into the epidural space of patients with chronic pain syndrome post-laminectomy through epiduroscopia about physical capacity. The investigators are using the Oswestry Disability Index - ODI.
To evaluate the use of analgesic medications [ Time Frame: 01 year ] [ Designated as safety issue: Yes ]
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: 01 year ] [ Designated as safety issue: Yes ]
The side effects or adverse effects will be assessed according to CTCAE 4.0. In case of complications, will be recorded and analyzed.

Estimated Enrollment:	30
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Procedure: Epiduroscopy with ozone therapy Patients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy.
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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Sciatic pain of 5 or more on Visual Analogue Scale
Previus 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172457

Contacts

Contact: Francisco Nêuton O Magalhães, MD

+ 55 11 8085 8666

neuton11@yahoo.com

Locations

Brazil
University of São Paulo Medical School	Recruiting
São Paulo, Brazil, 01060-970
Contact: Erich T Fonoff, PhD +55 11 32372031 fonoffet@usp.br
Contact: Welligson Paiva, MD +55 11 75992245 wellingsonpaiva@yahoo.com.br
Principal Investigator: Francisco Neuton O Magalhaes, MD
Sub-Investigator: Erich T Fonoff, PhD
Sub-Investigator: Arthur Ungaretti, MD

Sponsors and Collaborators

University of Sao Paulo

More Information

Publications:

Fai KR, Engleback M, Norman JB, Griffiths R. Interlaminar approach for epiduroscopy in patients with failed back surgery syndrome. Br J Anaesth. 2009 Feb;102(2):280; author reply 280-1. No abstract available.

Gillespie G, MacKenzie P. Epiduroscopy--a review. Scott Med J. 2004 Aug;49(3):79-81. Review. No abstract available.

Geurts JW, Kallewaard JW, Richardson J, Groen GJ. Targeted methylprednisolone acetate/hyaluronidase/clonidine injection after diagnostic epiduroscopy for chronic sciatica: a prospective, 1-year follow-up study. Reg Anesth Pain Med. 2002 Jul-Aug;27(4):343-52.

Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adhesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician. 2010 Mar;13(2):E91-E110.

Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. A comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing lumbar post surgery syndrome: a randomized, equivalence controlled trial. Pain Physician. 2009 Nov-Dec;12(6):E355-68.

Manchikanti L, Boswell MV, Datta S, Fellows B, Abdi S, Singh V, Benyamin RM, Falco FJ, Helm S, Hayek SM, Smith HS; ASIPP. Comprehensive review of therapeutic interventions in managing chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):E123-98. Review.

Hayek SM, Helm S, Benyamin RM, Singh V, Bryce DA, Smith HS. Effectiveness of spinal endoscopic adhesiolysis in post lumbar surgery syndrome: a systematic review. Pain Physician. 2009 Mar-Apr;12(2):419-35. Review.

Epter RS, Helm S 2nd, Hayek SM, Benyamin RM, Smith HS, Abdi S. Systematic review of percutaneous adhesiolysis and management of chronic low back pain in post lumbar surgery syndrome. Pain Physician. 2009 Mar-Apr;12(2):361-78. Review.

Sakai T, Aoki H, Hojo M, Takada M, Murata H, Sumikawa K. Adhesiolysis and targeted steroid/local anesthetic injection during epiduroscopy alleviates pain and reduces sensory nerve dysfunction in patients with chronic sciatica. J Anesth. 2008;22(3):242-7. Epub 2008 Aug 7.

Racz GB, Heavner JE, Trescot A. Percutaneous lysis of epidural adhesions--evidence for safety and efficacy. Pain Pract. 2008 Jul-Aug;8(4):277-86. Epub 2008 May 23. Review. Erratum in: Pain Pract. 2009 May-Jun;9(3):244.

Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L; American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007 Jan;10(1):7-111.

Manchikanti L, Pampati V, Fellows B, Rivera JJ, Damron KS, Beyer C, Cash KA. Effectiveness of percutaneous adhesiolysis with hypertonic saline neurolysis in refractory spinal stenosis. Pain Physician. 2001 Oct;4(4):366-73.

Mavrocordatos P, Cahana A. Minimally invasive procedures for the treatment of failed back surgery syndrome. Adv Tech Stand Neurosurg. 2006;31:221-52. Review.

Steppan J, Meaders T, Muto M, Murphy KJ. A metaanalysis of the effectiveness and safety of ozone treatments for herniated lumbar discs. J Vasc Interv Radiol. 2010 Apr;21(4):534-48. Epub 2010 Feb 25. Review.

Das G, Ray S, Ishwarari S, Roy M, Ghosh P. Ozone nucleolysis for management of pain and disability in prolapsed lumber intervertebral disc. A prospective cohort study. Interv Neuroradiol. 2009 Sep;15(3):330-4. Epub 2009 Nov 4.

Paoloni M, Di Sante L, Cacchio A, Apuzzo D, Marotta S, Razzano M, Franzini M, Santilli V. Intramuscular oxygen-ozone therapy in the treatment of acute back pain with lumbar disc herniation: a multicenter, randomized, double-blind, clinical trial of active and simulated lumbar paravertebral injection. Spine. 2009 Jun 1;34(13):1337-44.

Staal JB, de Bie RA, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low back pain: an updated Cochrane review. Spine. 2009 Jan 1;34(1):49-59. Review.

Muto M, Ambrosanio G, Guarnieri G, Capobianco E, Piccolo G, Annunziata G, Rotondo A. Low back pain and sciatica: treatment with intradiscal-intraforaminal O(2)-O (3) injection. Our experience. Radiol Med. 2008 Aug;113(5):695-706. Epub 2008 Jul 1. English, Italian.

Oder B, Loewe M, Reisegger M, Lang W, Ilias W, Thurnher SA. CT-guided ozone/steroid therapy for the treatment of degenerative spinal disease--effect of age, gender, disc pathology and multi-segmental changes. Neuroradiology. 2008 Sep;50(9):777-85. Epub 2008 May 16.

Gallucci M, Limbucci N, Zugaro L, Barile A, Stavroulis E, Ricci A, Galzio R, Masciocchi C. Sciatica: treatment with intradiscal and intraforaminal injections of steroid and oxygen-ozone versus steroid only. Radiology. 2007 Mar;242(3):907-13. Epub 2007 Jan 5.

Bertoli AM, Alarcón GS. Ozone therapy and lower back pain. AJNR Am J Neuroradiol. 2006 Mar;27(3):471; author reply 471. No abstract available.

Bonetti M, Fontana A, Cotticelli B, Volta GD, Guindani M, Leonardi M. Intraforaminal O(2)-O(3) versus periradicular steroidal infiltrations in lower back pain: randomized controlled study. AJNR Am J Neuroradiol. 2005 May;26(5):996-1000.

Bonetti M, Fontana A, Albertini F. CT-guided oxygen-ozone treatment for first degree spondylolisthesis and spondylolysis. Acta Neurochir Suppl. 2005;92:87-92.

Muto M, Andreula C, Leonardi M. Treatment of herniated lumbar disc by intradiscal and intraforaminal oxygen-ozone (O2-O3) injection. J Neuroradiol. 2004 Jun;31(3):183-9.

Responsible Party:	University of São Paulo, Manoel Jacobsen Teixeira
ClinicalTrials.gov Identifier:	NCT01172457 History of Changes
Other Study ID Numbers:	Epiduroscopy trial
Study First Received:	July 28, 2010
Last Updated:	July 28, 2010
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by 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:

Back Pain
Low Back Pain
Failed Back Surgery Syndrome
Pain
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013