Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain
TerminatedPhase 4NCT00749554
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Brief summary (from the registry)
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 life of patients with chronic mechanical discogenic low back pain.
Study details
- Official title
- Blinded Randomised Placebo-Controlled Trial of TransDiscal Biacuplasty for Patients With Mechanical Low Back Pain of Disc Origin
- Conditions
- Interventions
- Device: Disc biacuplasty
- Device: Sham biacuplasty
- Sponsor
- Baylis Medical Company
- Collaborators
- University of Alberta
- Start date
- 2008-04
- Primary completion
- 2010-08
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00749554