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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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).
Probes not inserted into disc, no RF electricity applied.
Lacombe Hospital
Lacombe, Alberta, Canada
Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS).
Time frame: 12 months
Oswestry Disability Index
Time frame: 12 months
Assessment of Quality of Life
Time frame: 12 months
SF-36 for physical functioning
Time frame: 12 months
Reduction in Medication Intake
Time frame: 12 months
Patient satisfaction
Time frame: 12 months
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