Status:
TERMINATED
Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain
Lead Sponsor:
Baylis Medical Company
Collaborating Sponsors:
University of Alberta
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this randomized controlled trial is to evaluate the effectiveness of Disc Biacuplasty in relieving pain, reducing medication intake and improving function, satisfaction and quality of l...
Eligibility Criteria
Inclusion
- Age \>18 years
- 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
- Active radicular pain
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00749554
Start Date
April 1 2008
Last Update
June 7 2010
Active Locations (1)
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1
Lacombe Hospital
Lacombe, Alberta, Canada, T4L 1G8