Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain

Low Back Pain Clinical Trial

— TD-RCT-002  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00749554
• Other study ID #: TD-RCT-Burnham
• Status: Terminated
• Phase: Phase 4
• First received: September 8, 2008
• Last updated: June 4, 2010
• Start date: April 2008

Study information

• Verified date: June 2010
• Source: Baylis Medical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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).
• Sham biacuplasty
Probes not inserted into disc, no RF electricity applied.

Locations

Country	Name	City	State
Canada	Lacombe Hospital	Lacombe	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Baylis Medical Company	University of Alberta

Country where clinical trial is conducted

Canada, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS).		12 months	No
Secondary	Oswestry Disability Index		12 months	No
Secondary	Assessment of Quality of Life		12 months	No
Secondary	SF-36 for physical functioning		12 months	No
Secondary	Reduction in Medication Intake		12 months	No
Secondary	Patient satisfaction		12 months	No