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NCT03997825 Clinical Trial

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

Chronic Low Back Pain Clinical Trial

— SMART  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03997825
Other study ID # CIP 0011
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 13, 2019
Est. completion date November 8, 2019

Study information
Verified date December 2020
Source Relievant Medsystems, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 117
Est. completion date November 8, 2019
Est. primary completion date November 8, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Basivertebral Nerve (BVN) Ablation
Single follow-up visit of previously treated participants from the SMART trial.

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

Sponsors (1)
Lead Sponsor Collaborator
Relievant Medsystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Difference between baseline and 5 year post treatment measurements
Secondary 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. Difference between baseline and 5 year post treatment measurements
Secondary 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. At 5 year post treatment
Secondary 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. Difference between baseline and 5 years post treatment.
Secondary 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. Difference from baseline percentage measurement to 5 years post treatment measurement
Secondary 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. Measured form treatment data to 5 years post treatment visit date
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