Clinical trial NCT00749554: Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain
Official title: Blinded Randomised Placebo-Controlled Trial of TransDiscal Biacuplasty for Patients With Mechanical Low Back Pain of Disc Origin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: Cooled Radiofrequency
Disc biacuplasty
TransDiscal system
Discogenic pain
Lead sponsor: Baylis Medical Company
Sponsor class: INDUSTRY
Collaborators: name: University of Alberta
First posted: 2008-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 life of patients with chronic mechanical discogenic low back pain.


Eligibility criteria: 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

Primary outcomes:
measure: Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS).
timeFrame: 12 months
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 12 months
measure: Assessment of Quality of Life
timeFrame: 12 months
measure: SF-36 for physical functioning
timeFrame: 12 months
measure: Reduction in Medication Intake
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Lacombe
country: Canada
facility: Lacombe Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Robert S Burnham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.