Low Back PainPhase 2EpiduroscopyNCT01172457
The Effect of Epiduroscopy and Ozone Therapy in Patients With Failed Back Surgery Syndrome
A Phase 2 study testing Epiduroscopy with oxygen therapy and Epiduroscopy with ozone therapy in people with Low Back Pain and Failed Back Surgery Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain, Failed Back Surgery Syndrome
- What is being tested?
- Epiduroscopy with oxygen therapy and Epiduroscopy with ozone therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2009to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo Medical School
São Paulo, São Paulo, 01060-970
About this study
Official title: A Randomized, Double-Blind Study to Evaluate the Effect of Epiduroscopy and Ozone Therapy in Patients With Failed Back Surgery Syndrome
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.
Read the 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
- Being tested
- Epiduroscopy with oxygen therapy, Epiduroscopy with ozone therapy
- Keywords
- low back pain, failed back surgery syndrome (FBSS), epidural fibrosis, ozone therapy, oxygen therapy, epiduroscopy, spinal endoscopy
- Medical subject headings
- Low Back Pain, Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiduroscopy with oxygen therapyProcedure or surgery
Patients in this group will receive 30 mL of oxygen by epiduroscopy.
Epiduroscopy with ozone therapyProcedure or surgery
Patients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Epiduroscopy with ozone therapy | Active comparator | Patients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy. Receives: Procedure: Epiduroscopy with ozone therapy |
| Epiduroscopy with oxygen therapy | Placebo comparator | Patients in this group will receive 30 mL of oxygen by epiduroscopy. Receives: Procedure: Epiduroscopy with oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of ozone versus placebo (oxygen) applied into the epidural space of patients with Failed Back Surgery Syndrome (FBSS) through epiduroscopy.
The pain intensity is measured by visual analog pain scale - VAS
Measured: up to 01 year
Secondary outcomes (5)
To evaluate the psychological aspects.
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.
Measured: up to 01 year
The quality of life.
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.
Measured: up to 01 year
To evaluate the physical capacity
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.
Measured: up to 01 year
To evaluate the use of analgesic medications
The researchers will evaluate the amount of analgesic medications used during the monitoring period.
Measured: up to 01 year
To evaluate the rate of side effects or complications
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.
Measured: up to 01 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startMay 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neuton Magalhaes, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172457
- Sponsor's protocol ID
- Epiduroscopy trial
- Acronym
- Epiduroscopy
- Status last verified
- Aug 2013
- First submitted
- 28 Jul 2010
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gillespie G, MacKenzie P. Epiduroscopy--a review. Scott Med J. 2004 Aug;49(3):79-81. doi: 10.1177/003693300404900301. No abstract available.
PubMed 15462218Geurts 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.
PubMed 12132057Manchikanti 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.
PubMed 20309389Manchikanti 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.
PubMed 19935992Manchikanti 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.
PubMed 19668281Hayek 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.
PubMed 19305488Epter 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.
PubMed 19305485Sakai 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.
PubMed 18685930Racz 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.
PubMed 18503627Boswell 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.
PubMed 17256025Manchikanti 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.
PubMed 16902683Mavrocordatos 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.
PubMed 16768306Steppan 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.
PubMed 20188591Das 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.
PubMed 20465917Paoloni 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.
PubMed 19478653
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study to Evaluate the Effect of Epiduroscopy and Ozone Therapy in Patients With Failed Back Surgery Syndrome
- ClinicalTrials.gov ID
- NCT01172457
- Acronym / sponsor ID
- Epiduroscopy / Epiduroscopy trial
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epiduroscopy with ozone therapy | Active comparator | Procedure: Epiduroscopy with ozone therapyPatients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy. |
| Epiduroscopy with oxygen therapy | Placebo comparator | Procedure: Epiduroscopy with oxygen therapyPatients in this group will receive 30 mL of oxygen by epiduroscopy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epiduroscopy with oxygen therapyPatients in this group will receive 30 mL of oxygen by epiduroscopy. | Procedure or surgery | Epiduroscopy with oxygen therapy |
| Epiduroscopy with ozone therapyPatients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy. | Procedure or surgery | Epiduroscopy with ozone therapy |
Primary outcome
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
The pain intensity is measured by visual analog pain scale - VAS
5 secondary outcomes
To evaluate the psychological aspects.
Time frame: up to 01 year
The quality of life.
Time frame: up to 01 year
To evaluate the physical capacity
Time frame: up to 01 year
To evaluate the use of analgesic medications
Time frame: up to 01 year
To evaluate the rate of side effects or complications
Time frame: up to 01 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
- Background: PubMed 15462218Gillespie G, MacKenzie P. Epiduroscopy--a review. Scott Med J. 2004 Aug;49(3):79-81. doi: 10.1177/003693300404900301. No abstract available.
- Background: PubMed 12132057Geurts 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.
- Background: PubMed 20309389Manchikanti 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.
- Background: PubMed 19935992Manchikanti 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.
- Background: PubMed 19668281Manchikanti 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.
- Background: PubMed 19305488Hayek 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.
- Background: PubMed 19305485Epter 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.
- Background: PubMed 18685930Sakai 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.
- Background: PubMed 18503627Racz 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.
- Background: PubMed 17256025Boswell 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.
- Background: PubMed 16902683Manchikanti 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.
- Background: PubMed 16768306Mavrocordatos 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epiduroscopy with oxygen therapy and Epiduroscopy with ozone therapy in people with Low Back Pain and Failed Back Surgery Syndrome, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172457, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.