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

Baylis Medical Company1 site in 1 country40 target enrollmentApril 2008

ConditionsLow Back Pain

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: Baylis Medical Company
Enrollment: 40
Locations: 1
Primary Endpoint: Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS).
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

August 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baylis Medical Company

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)