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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neuton Magalhaes, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01172457
First received: July 28, 2010
Last updated: August 28, 2013
Last verified: August 2013
  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, 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.


Condition Intervention Phase
Low Back Pain
Failed Back Surgery Syndrome
Procedure: Epiduroscopy with oxygen therapy
Procedure: Epiduroscopy with ozone therapy
Phase 2

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:


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: up to 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: up to 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.

  • The quality of life. [ Time Frame: up to 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 epiduroscopy about the quality of life using the WHOQOL questionaire.

  • To evaluate the physical capacity [ Time Frame: up to 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 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 ] [ 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: up to 01 year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 40
Study Start Date: May 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
University of São Paulo Medical School
São Paulo, Brazil, 01060-970
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications:

Responsible Party: Neuton Magalhaes, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01172457     History of Changes
Other Study ID Numbers: Epiduroscopy trial
Study First Received: July 28, 2010
Last Updated: August 28, 2013
Health Authority: Brazil: National Committee of Ethics in Research (CONEP)

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:
Syndrome
Back Pain
Low Back Pain
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications

ClinicalTrials.gov processed this record on September 18, 2014