Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Relievant Medsystems, Inc.
Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up).
Control arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of 176.5 days.
Age
25–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Skeletally mature subjects at least 25 years of age
Chronic lower back pain for at least 6 months
Failure to respond to at least 6 months of non-operative conservative management
You may not be if
Radicular pain
Current or history of spinal infection
Modic changes at vertebral bodies other than L3 to S1
Contraindication to MRI
Pregnant, lactating or plan to become pregnant in next year
Has life expectancy of less than 2 years
Compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired
