Skip to main content
OpenTrials
Completed

NCT Number: NCT03997825

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Low Back Pain

Sex eligibility

All sexes

Study type

Observational

Primary location

Desert Institute for Spine Care, Phoenix, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LBP at least 6 months from original SMART Trial
  • RF Ablation Arm from SMART Trial

Exclusion criteria

-Control Arm Subjects from SMART Trial

Treatment and study plan

Basivertebral Nerve (BVN) Ablation

Device

Single follow-up visit of previously treated participants from the SMART trial.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Relievant Medsystems, Inc.

Industry

Registry information

Official study title

Five-Plus Year Follow-Up of SMART (Surgical Multicenter Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) Trial

Acronym: SMART

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2019
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.