NCT00749554

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_4 low-back-pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Last Updated

June 7, 2010

Status Verified

June 1, 2010

Enrollment Period

2.3 years

First QC Date

September 8, 2008

Last Update Submit

June 4, 2010

Conditions

Low Back Pain

Keywords

Cooled RadiofrequencyDisc biacuplastyTransDiscal systemDiscogenic pain

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (5)

  • Oswestry Disability Index

    12 months

  • Assessment of Quality of Life

    12 months

  • SF-36 for physical functioning

    12 months

  • Reduction in Medication Intake

    12 months

  • Patient satisfaction

    12 months

Study Arms (2)

Disc biacuplasty

ACTIVE COMPARATOR
Device: Disc biacuplasty

Sham treatment.

PLACEBO COMPARATOR
Device: Sham biacuplasty

Interventions

Disc biacuplastyDEVICE

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).

Also known as: TransDiscal, Cooled Radiofrequency, Intradiscal biacuplasty
Disc biacuplasty
Sham biacuplastyDEVICE

Probes not inserted into disc, no RF electricity applied.

Sham treatment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lacombe Hospital

Lacombe, Alberta, T4L 1G8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 18254768BACKGROUND

  • 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.

    PMID: 18489632BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert S Burnham, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2010

Last Updated

June 7, 2010

Record last verified: 2010-06

Locations

CA(1)