The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.
This is a prospective multi-center, nonintervention, observational, single arm post market data collection of the 5+ year effectiveness and satisfaction outcome for the SMART trial population.
Study Type
OBSERVATIONAL
Enrollment
117
Single follow-up visit of previously treated participants from the SMART trial.
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
LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline
Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Difference in mean ODI at baseline and 5 years post treatment measurements.
Time frame: Difference between baseline and 5 year post treatment measurements
LS Mean Reduction in VAS From Baseline
Numeric pain scale with minimum of 0 to maximum of 10; with 0 being no pain and 10 being worst imaginable pain. Difference in mean VAS at baseline and at 5 years post treatment.
Time frame: Difference between baseline and 5 year post treatment measurements
Responder Rates
Proportion of participants that achieve a threshold of \> 15 point reduction in ODI and \> 2 point reduction in VAS calculated as the difference between the baseline measurements and the 5 year post treatment measurements.
Time frame: At 5 year post treatment
Narcotics Use
Proportion of participants using a narcotic more than once per week in the 30 days prior to the study visit. Difference in baseline to 5 year post treatment percentage measurements.
Time frame: Difference between baseline and 5 years post treatment.
Injections
Proportion of participants receiving an injection for low back pain (adjudicated as same location and etiology as BVN ablation treatment) compared to baseline. Difference in percentage of participants at baseline and 5 years post treatment measurements.
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Cedars Sinai Spine Center
Los Angeles, California, United States
Drug Studies of America
Marietta, Georgia, United States
Indiana Spine Group
Carmel, Indiana, United States
Maine Medical Partners
Scarborough, Maine, United States
Michigan Orthopedics Instititute
Southfield, Michigan, United States
OrthoCarolina
Charlotte, North Carolina, United States
Pacific Sports and Spine
Eugene, Oregon, United States
...and 3 more locations
Time frame: Difference from baseline percentage measurement to 5 years post treatment measurement
Interventions
Proportion of participants receiving a pain intervention or surgery for low back pain (adjudicated as the same location and etiology as BVN ablation treatment) from procedure date to 5 year visit date.
Time frame: Measured form treatment data to 5 years post treatment visit date