Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain
NCT ID: NCT00749554
Last Updated: 2010-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
40 participants
INTERVENTIONAL
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Disc biacuplasty
Disc biacuplasty
The lesion duration will be 15 minutes with a ramp rate of 2°C per minute and a peak set temperature of 45°C (Temperature in posterior annulus of disc reaches 65°C).
Sham treatment.
Sham biacuplasty
Probes not inserted into disc, no RF electricity applied.
Interventions
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Disc biacuplasty
The lesion duration will be 15 minutes with a ramp rate of 2°C per minute and a peak set temperature of 45°C (Temperature in posterior annulus of disc reaches 65°C).
Sham biacuplasty
Probes not inserted into disc, no RF electricity applied.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to understand the informed consent and baseline/follow-up questionnaires
* Chronic low back pain \> leg pain for longer than 6 months, unresponsive to comprehensive non-operative treatment
* No clinical evidence of SI joint mediated pain
* Concordant pain reproduced on provocative discography at an intensity of \>6/10 at low pressure (\<50 psi) at not more than 2 discs and a negative response at an adjacent control disc
* Preservation of at least 50% height of the symptomatic disc(s)
Exclusion Criteria
* Nucleus pulposus herniation \> 5 mm, extrusion or sequestration on MRI
* Spondylolithesis at the symptomatic level
* Prior surgery at the symptomatic level
* Concomitant cervical or thoracic pain \>2/10 (VAS) in severity
* Other chronic pain conditions (i.e. Fibromyalgia Syndrome)
* Immunosuppression (i.e. Cancer, AIDS, Rheumatoid arthritis)
* Third-party (WSIB, litigation or insurance) involvement
* Psychological issues impeding recovery by history, examination and/or a Beck Depression Inventory score of \>20
* Systemic or localized infection (at the anticipated needle entry sites)
* BMI \> 35 (Obesity)
* Substance or opioid abuse
* Coagulopathy
18 Years
ALL
No
Sponsors
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University of Alberta
OTHER
Baylis Medical Company
INDUSTRY
Responsible Party
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University of Alberta
Principal Investigators
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Robert S Burnham, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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Lacombe Hospital
Lacombe, Alberta, Canada
Countries
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References
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Kapural L, Ng A, Dalton J, Mascha E, Kapural M, de la Garza M, Mekhail N. Intervertebral disc biacuplasty for the treatment of lumbar discogenic pain: results of a six-month follow-up. Pain Med. 2008 Jan-Feb;9(1):60-7. doi: 10.1111/j.1526-4637.2007.00407.x.
Kapural L. Intervertebral disk cooled bipolar radiofrequency (intradiskal biacuplasty) for the treatment of lumbar diskogenic pain: a 12-month follow-up of the pilot study. Pain Med. 2008 May-Jun;9(4):407-8. doi: 10.1111/j.1526-4637.2008.00464.x. No abstract available.
Other Identifiers
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TD-RCT-Burnham
Identifier Type: -
Identifier Source: org_study_id
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