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

June 4, 2010 updated by: Baylis Medical Company

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Lacombe, Alberta, Canada, T4L 1G8
        • Lacombe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Oswestry Disability Index
Time Frame: 12 months
12 months
Assessment of Quality of Life
Time Frame: 12 months
12 months
SF-36 for physical functioning
Time Frame: 12 months
12 months
Reduction in Medication Intake
Time Frame: 12 months
12 months
Patient satisfaction
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylis Medical Company

Collaborators

University of Alberta

Investigators

  • Principal Investigator: Robert S Burnham, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

September 8, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

June 7, 2010

Last Update Submitted That Met QC Criteria

June 4, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD-RCT-Burnham

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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