The Effect of Epiduroscopy and Ozone Therapy in Patients With Failed Back Surgery Syndrome

NCT ID: NCT01172457

Last Updated: 2013-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-07-31

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 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, Neuropathic Pain 4, Neuropathic Pain Symptom Inventory), quality of life scale (WHOQOL), functional scales of pain disability (Roland Morris and Oswestry Disabilities Scales). Only one researcher will keep the data confidential until the end of the study.

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. Between 40% and 80% of patients undergoing back surgery continue to experience persistent pain, a condition called Failed Back Surgery Syndrome (FBSS). The symptoms of FBSS are of persistent or recurring low back pain and / or leg pain after one or more spinal operations. The precise cause of the pain can be difficult to determine due to the complex interaction of biological and psychosocial factors. Possible organic causes of FBSS include epidural fibrosis, arachnoiditis, mechanical factors, pressure induced changes in the nerve root, structural changes in the vertebral column, and lumbar degenerative disease. With a second surgical intervention for fibrosis, there is a 65-70% failure rate, with 15-20% of the patients reporting worsening of symptoms. Thus, repeated surgery tends to yield poorer results.

The ozone therapy has emerged as an option or additional treatment for these patients, mostly in Europe. Despite of its wide use to treat a variety of conditions, ozone therapy is still unknown to most physicians. Ozone (O3) is an allotropic form of oxygen, primarily known for its ecological properties, industrial applications, but also by its therapeutic effects. Some questions persist concerning its potential toxicity as an oxidant agent versus the reported clinical efficacy. Several mechanisms of action have been proposed to explain the efficacy of the ozone therapy: analgesic, anti-inflammatory and oxidant action on proteoglycan (e.g. in the nucleus pulpous). Ozone is administered in the form of an oxygen-ozone gas mixture at nontoxic concentrations varying from 1 to 40 µg of ozone per milliliter of oxygen by various percutaneous methods for treatment of low back pain. However, still no well-designed studies that allow conclusions about the safety and efficacy of ozone in the treatment of low back pain.

Spinal endoscopy, or "epiduroscopy", is the examination of the epidural space by a minimally invasive technique that allows the diagnosis and treatment of chronic back pain and radiculopathy. The therapeutic potential of epiduroscopy and adhesiolysis, a minimally invasive but potentially useful treatment modality in the management of refractory radiculopathy, emerged during the 1990s.

Epiduroscopy is carried out under local anesthesia with the patient awake, thus avoiding potential unrecognized pressure effects in the epidural canal. Light intravenous sedation and analgesia may be required to ensure full patient cooperation while maintaining verbal contact. The patient is positioned prone with a pillow under his/her hips. The procedure is carried out under aseptic conditions with antibiotic prophylaxis and requires the use of an imagine intensifier. Sacrococcygeal ligament puncture is made with a 17g Tuohy needle and followed by a caudal epidurogram to confirm needle placement. A Seldinger technique is then used to place an introducer sheath in the sacral epidural canal. A 0.9mm fiber optic scope is placed with its tip and the end of a steerable video guided catheter.

The Video Guided Catheter and endoscope are then advanced via the introducer into epidural space. Slow irrigation with saline allows visualization of epidural space by gentle distension. Adhesiolysis can be carried out under direct vision by blunt dissection of the adhesions using the tip of the video guided catheter. Blunt dissection coupled with hydrostatic distension of the epidural space thus creates a pocket through which injected drug can access symptomatic nerve roots.

Several drugs have been used within the epidural space through the spinal endoscopy including steroid, local anesthetic, hyaluronidase, saline solution, clonidine and ozone most recently. Blind epidural injections of these therapeutic substances can, in some patients; fail to flow towards a symptomatic root due to obstruction by epidural fibrosis. Such patients may, therefore, benefit more from epidural injection if flow of inject towards the symptomatic root is facilitated following endoscopic division of epidural adhesions.

Thus, the investigators find this model of pain would be appropriate to evaluate the effects of ozone in treatment for the lumbar pain by comparison with a placebo, using the epiduroscopy to apply it.

Conditions

Low Back Pain; Failed Back Surgery Syndrome

Keywords

low back pain; failed back surgery syndrome (FBSS); epidural fibrosis; ozone therapy; oxygen therapy; epiduroscopy; spinal endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Epiduroscopy with ozone therapy

Patients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy.

Group Type: ACTIVE_COMPARATOR

Epiduroscopy with ozone therapy

Intervention Type: PROCEDURE

Patients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy.

Epiduroscopy with oxygen therapy

Patients in this group will receive 30 mL of oxygen by epiduroscopy.

Group Type: PLACEBO_COMPARATOR

Epiduroscopy with oxygen therapy

Intervention Type: PROCEDURE

Patients in this group will receive 30 mL of oxygen by epiduroscopy.

Interventions

Epiduroscopy with oxygen therapy

Patients in this group will receive 30 mL of oxygen by epiduroscopy.

Intervention Type: PROCEDURE

Epiduroscopy with ozone therapy

Patients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Neuton Magalhaes

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of São Paulo Medical School

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Gillespie G, MacKenzie P. Epiduroscopy--a review. Scott Med J. 2004 Aug;49(3):79-81. doi: 10.1177/003693300404900301. No abstract available.

Reference Type: BACKGROUND

PMID: 15462218 (View on PubMed)

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. doi: 10.1053/rapm.2002.27175.

Reference Type: BACKGROUND

PMID: 12132057 (View on PubMed)

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-Apr;13(2):E91-E110.

Reference Type: BACKGROUND

PMID: 20309389 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19935992 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19668281 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19305488 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19305485 (View on PubMed)

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. doi: 10.1007/s00540-008-0616-4. Epub 2008 Aug 7.

Reference Type: BACKGROUND

PMID: 18685930 (View on PubMed)

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. doi: 10.1111/j.1533-2500.2008.00203.x. Epub 2008 May 23.

Reference Type: BACKGROUND

PMID: 18503627 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17256025 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16902683 (View on PubMed)

Mavrocordatos P, Cahana A. Minimally invasive procedures for the treatment of failed back surgery syndrome. Adv Tech Stand Neurosurg. 2006;31:221-52. doi: 10.1007/3-211-32234-5_5.

Reference Type: BACKGROUND

PMID: 16768306 (View on PubMed)

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. doi: 10.1016/j.jvir.2009.12.393. Epub 2010 Feb 25.

Reference Type: BACKGROUND

PMID: 20188591 (View on PubMed)

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. doi: 10.1177/159101990901500311. Epub 2009 Nov 4.

Reference Type: BACKGROUND

PMID: 20465917 (View on PubMed)

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 (Phila Pa 1976). 2009 Jun 1;34(13):1337-44. doi: 10.1097/BRS.0b013e3181a3c18d.

Reference Type: BACKGROUND

PMID: 19478653 (View on PubMed)

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 (Phila Pa 1976). 2009 Jan 1;34(1):49-59. doi: 10.1097/BRS.0b013e3181909558.

Reference Type: BACKGROUND

PMID: 19127161 (View on PubMed)

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. doi: 10.1007/s11547-008-0302-5. Epub 2008 Jul 1. English, Italian.

Reference Type: BACKGROUND

PMID: 18594765 (View on PubMed)

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. doi: 10.1007/s00234-008-0398-2. Epub 2008 May 16.

Reference Type: BACKGROUND

PMID: 18483728 (View on PubMed)

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. doi: 10.1148/radiol.2423051934. Epub 2007 Jan 5.

Reference Type: BACKGROUND

PMID: 17209164 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 16551979 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15891150 (View on PubMed)

Bonetti M, Fontana A, Albertini F. CT-guided oxygen-ozone treatment for first degree spondylolisthesis and spondylolysis. Acta Neurochir Suppl. 2005;92:87-92. doi: 10.1007/3-211-27458-8_19.

Reference Type: BACKGROUND

PMID: 15830975 (View on PubMed)

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. doi: 10.1016/s0150-9861(04)96989-1.

Reference Type: BACKGROUND

PMID: 15356443 (View on PubMed)

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. doi: 10.1093/bja/aen371. No abstract available.

Reference Type: RESULT

PMID: 19151054 (View on PubMed)

Related Links

http://www.aboz.com.br

Related Info

Other Identifiers

Epiduroscopy trial

Identifier Type: -

Identifier Source: org_study_id