Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Disc biacuplasty
* Device: Sham biacuplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Disc biacuplasty<br> | Device: Disc biacuplasty<br>* 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).<br>* Other names: Intradiscal biacuplasty;|
| Placebo Comparator: Sham treatment.<br> | Device: Sham biacuplasty<br>* Probes not inserted into disc, no RF electricity applied.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cooled Radiofrequency, Disc biacuplasty, TransDiscal system, Discogenic pain