Five-Plus Year Follow-Up of SMART Randomized Controlled Trial (SMART)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03997825|
Recruitment Status : Completed
First Posted : June 25, 2019
Results First Posted : November 4, 2020
Last Update Posted : January 13, 2021
|Condition or disease||Intervention/treatment|
|Chronic Low Back Pain||Device: Basivertebral Nerve (BVN) Ablation|
|Study Type :||Observational|
|Actual Enrollment :||117 participants|
|Official Title:||Five-Plus Year Follow-Up of SMART (Surgical Multicenter Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) Trial|
|Actual Study Start Date :||June 13, 2019|
|Actual Primary Completion Date :||November 8, 2019|
|Actual Study Completion Date :||November 8, 2019|
- Device: Basivertebral Nerve (BVN) Ablation
Single follow-up visit of previously treated participants from the SMART trial.
- LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline [ Time Frame: 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.
- LS Mean Reduction in VAS From Baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997825
|United States, Arizona|
|Desert Institute for Spine Care|
|Phoenix, Arizona, United States, 85020|
|United States, California|
|SpineCare Medical Group|
|Daly City, California, United States, 94015|
|Memorial Orthopedic Surgical Group|
|Long Beach, California, United States, 90806|
|Cedars Sinai Spine Center|
|Los Angeles, California, United States, 90048|
|United States, Georgia|
|Drug Studies of America|
|Marietta, Georgia, United States, 30060|
|United States, Indiana|
|Indiana Spine Group|
|Carmel, Indiana, United States, 46032|
|United States, Maine|
|Maine Medical Partners|
|Scarborough, Maine, United States, 04074|
|United States, Michigan|
|Michigan Orthopedics Instititute|
|Southfield, Michigan, United States, 48033|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28207|
|United States, Oregon|
|Pacific Sports and Spine|
|Eugene, Oregon, United States, 97401|
|United States, Pennsylvania|
|Rothman Orthopedic Institute|
|Bensalem, Pennsylvania, United States, 19020|
|United States, Texas|
|Seton Spine and Scoliosis Center|
|Austin, Texas, United States, 78731|
|United States, Virginia|
|Virginia iSpine Physicians|
|Richmond, Virginia, United States, 23235|
|Principal Investigator:||Jeff Fischgrund, MD||William Beaumont Hospitals|