Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain

Blinded Randomised Placebo-Controlled Trial of TransDiscal Biacuplasty for Patients With Mechanical Low Back Pain of Disc Origin

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.

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