Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00749554

Acronym

TD-RCT-002

Enrollment

Registered

2008-09-09

Start date

2008-04-30

Completion date

Unknown

Last updated

2010-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Cooled Radiofrequency, Disc biacuplasty, TransDiscal system, Discogenic pain

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.

Interventions

DEVICEDisc 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).

DEVICESham biacuplasty

Probes not inserted into disc, no RF electricity applied.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026