Five-Plus Year Follow-Up of SMART Randomized Controlled Trial

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

-Control Arm Subjects from SMART Trial

Primary Outcome Measures

Name	Time	Method
LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline	Difference between baseline and 5 year post treatment measurements	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.

Secondary Outcome Measures

Name	Time	Method
LS Mean Reduction in VAS From Baseline	Difference between baseline and 5 year post treatment measurements	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.
Responder Rates	At 5 year post treatment	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.
Narcotics Use	Difference between baseline and 5 years post treatment.	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.
Injections	Difference from baseline percentage measurement to 5 years post treatment measurement	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.
Interventions	Measured form treatment data to 5 years post treatment visit date	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.

Locations (13): Desert Institute for Spine Care
🇺🇸
Phoenix, Arizona, United States
Maine Medical Partners
🇺🇸
Scarborough, Maine, United States
Michigan Orthopedics Instititute
🇺🇸
Southfield, Michigan, United States
Pacific Sports and Spine
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Eugene, Oregon, United States
Cedars Sinai Spine Center
🇺🇸
Los Angeles, California, United States
SpineCare Medical Group
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Daly City, California, United States
Memorial Orthopedic Surgical Group
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Long Beach, California, United States
Indiana Spine Group
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Carmel, Indiana, United States
Drug Studies of America
🇺🇸
Marietta, Georgia, United States
Virginia iSpine Physicians
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Richmond, Virginia, United States
OrthoCarolina
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Charlotte, North Carolina, United States
Rothman Orthopedic Institute
🇺🇸
Bensalem, Pennsylvania, United States
Seton Spine and Scoliosis Center
🇺🇸
Austin, Texas, United States