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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749554
Recruitment Status : Terminated (Primary Investigator Retired.)
First Posted : September 9, 2008
Last Update Posted : June 7, 2010
University of Alberta
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Disc biacuplasty Device: Sham biacuplasty Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : April 2008
Estimated Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS). [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 12 months ]
  2. Assessment of Quality of Life [ Time Frame: 12 months ]
  3. SF-36 for physical functioning [ Time Frame: 12 months ]
  4. Reduction in Medication Intake [ Time Frame: 12 months ]
  5. Patient satisfaction [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00749554

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

Responsible Party: Dr. Robert S. Burnham, University of Alberta Identifier: NCT00749554     History of Changes
Other Study ID Numbers: TD-RCT-Burnham
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: June 2010

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

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