search
Back to results

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

Primary Purpose

Low Back Pain

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Disc biacuplasty
Sham biacuplasty
Sponsored by
Baylis Medical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Cooled Radiofrequency, Disc biacuplasty, TransDiscal system, Discogenic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lacombe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Disc biacuplasty

Sham treatment.

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oswestry Disability Index
Assessment of Quality of Life
SF-36 for physical functioning
Reduction in Medication Intake
Patient satisfaction

Full Information

First Posted
September 8, 2008
Last Updated
June 4, 2010
Sponsor
Baylis Medical Company
Collaborators
University of Alberta
search

1. Study Identification

Unique Protocol Identification Number
NCT00749554
Brief Title
Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain
Acronym
TD-RCT-002
Official Title
Blinded Randomised Placebo-Controlled Trial of TransDiscal Biacuplasty for Patients With Mechanical Low Back Pain of Disc Origin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Primary Investigator Retired.
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Baylis Medical Company
Collaborators
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Cooled Radiofrequency, Disc biacuplasty, TransDiscal system, Discogenic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Disc biacuplasty
Arm Type
Active Comparator
Arm Title
Sham treatment.
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Disc biacuplasty
Other Intervention Name(s)
TransDiscal, Cooled Radiofrequency, Intradiscal biacuplasty
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Sham biacuplasty
Intervention Description
Probes not inserted into disc, no RF electricity applied.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Oswestry Disability Index
Time Frame
12 months
Title
Assessment of Quality of Life
Time Frame
12 months
Title
SF-36 for physical functioning
Time Frame
12 months
Title
Reduction in Medication Intake
Time Frame
12 months
Title
Patient satisfaction
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Burnham, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lacombe Hospital
City
Lacombe
State/Province
Alberta
ZIP/Postal Code
T4L 1G8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18254768
Citation
Kapural L, Ng A, Dalton J, Mascha E, Kapural M, de la Garza M, Mekhail N. Intervertebral disc biacuplasty for the treatment of lumbar discogenic pain: results of a six-month follow-up. Pain Med. 2008 Jan-Feb;9(1):60-7. doi: 10.1111/j.1526-4637.2007.00407.x.
Results Reference
background
PubMed Identifier
18489632
Citation
Kapural L. Intervertebral disk cooled bipolar radiofrequency (intradiskal biacuplasty) for the treatment of lumbar diskogenic pain: a 12-month follow-up of the pilot study. Pain Med. 2008 May-Jun;9(4):407-8. doi: 10.1111/j.1526-4637.2008.00464.x. No abstract available.
Results Reference
background

Learn more about this trial

Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain

We'll reach out to this number within 24 hrs