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Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain

NCT00749554 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-06-07

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

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).

DEVICE

Sham biacuplasty

Probes not inserted into disc, no RF electricity applied.

Sponsors & Collaborators

  • University of Alberta

    collaborator OTHER

  • Baylis Medical Company

    lead INDUSTRY

Principal Investigators

  • Robert S Burnham, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00749554 on ClinicalTrials.gov