Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain

Phase 4

Terminated

• Conditions: Low Back Pain
• Interventions: Device: Disc biacuplasty; Device: Sham biacuplasty

• Registration Number: NCT00749554
• Lead Sponsor: Baylis Medical Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-04
• Last Update Posted: 2010-06-07
• Primary Completion: 2010-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disc biacuplasty	Disc biacuplasty	-
Sham treatment.	Sham biacuplasty	-

Primary Outcome Measures

Name	Time	Method
Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS).	12 months

Secondary Outcome Measures

Name	Time	Method
Reduction in Medication Intake	12 months
Patient satisfaction	12 months
Assessment of Quality of Life	12 months
SF-36 for physical functioning	12 months
Oswestry Disability Index	12 months

Trial Locations

Locations (1)

Lacombe Hospital; 🇨🇦 Lacombe, Alberta, Canada