Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain (TD-RCT-002)

This study has been terminated.
(Primary Investigator Retired.)
Sponsor:
Collaborator:
University of Alberta
Information provided by:
Baylis Medical Company
ClinicalTrials.gov Identifier:
NCT00749554
First received: September 8, 2008
Last updated: June 4, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Device: Disc biacuplasty
Device: Sham biacuplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Blinded Randomised Placebo-Controlled Trial of TransDiscal Biacuplasty for Patients With Mechanical Low Back Pain of Disc Origin

Resource links provided by NLM:


Further study details as provided by Baylis Medical Company:

Primary Outcome Measures:
  • Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assessment of Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • SF-36 for physical functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Reduction in Medication Intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2008
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Disc biacuplasty Device: Disc biacuplasty
The lesion duration will be 15 minutes with a ramp rate of 2°C per minute and a peak set temperature of 45°C (Temperature in posterior annulus of disc reaches 65°C).
Other Names:
  • TransDiscal
  • Cooled Radiofrequency
  • Intradiscal biacuplasty
Placebo Comparator: Sham treatment. Device: Sham biacuplasty
Probes not inserted into disc, no RF electricity applied.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749554

Locations
Canada, Alberta
Lacombe Hospital
Lacombe, Alberta, Canada, T4L 1G8
Sponsors and Collaborators
Baylis Medical Company
University of Alberta
Investigators
Principal Investigator: Robert S Burnham, MD University of Alberta
  More Information

Publications:
Responsible Party: Dr. Robert S. Burnham, University of Alberta
ClinicalTrials.gov Identifier: NCT00749554     History of Changes
Other Study ID Numbers: TD-RCT-Burnham
Study First Received: September 8, 2008
Last Updated: June 4, 2010
Health Authority: Canada: Health Canada

Keywords provided by Baylis Medical Company:
Cooled Radiofrequency
Disc biacuplasty
TransDiscal system
Discogenic pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014