To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. This is a prospective, double-blind, randomized, sham-controlled clinical trial with an optional crossover component.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
225
Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.
Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.
Desert Institute for Spine Care
Phoenix, Arizona, United States
SpineCare Medical Group
Daly City, California, United States
Memorial Orthopedic Surgical Group
Long Beach, California, United States
Change in ODI From Baseline to 3 Months Post-treatment
The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain. ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.
Time frame: 3 months
Patient Success at 3 Months
Proportion of subjects with clinical success at 3 months, where clinical success was defined as: * 3 month ODI score represented at least a 15-point reduction from baseline * no device or procedure related SAE between baseline and 3 mos. * no increase in opioid use between procedure and 3 mos. * no deficit in a motor or dermatomal sensory group at the treated level at 3 mos. * no operative interventions or invasive procedures for lumbar back pain by a pain management or spinal specialist between procedure and 3 mos.
Time frame: 3 months
Change in ODI From Baseline to 6 Months Post-treatment
The improvement in ODI at 6 months compared to baseline. ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Spine Institute
Santa Monica, California, United States
Pain Center Solutions
Marietta, Georgia, United States
Indiana Spine Group
Carmel, Indiana, United States
Maine Medical Partners
Scarborough, Maine, United States
Partners in Research and Educational Studies of Spinal Disorders (PressD)
Southfield, Michigan, United States
OrthoCarolina
Charlotte, North Carolina, United States
NeuroSpine Institute
Eugene, Oregon, United States
...and 3 more locations