Trial Outcomes & Findings for Five-Plus Year Follow-Up of SMART Randomized Controlled Trial (NCT NCT03997825)

Last Updated: 2021-01-13

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

117 participants

Primary outcome timeframe

Difference between baseline and 5 year post treatment measurements

Results posted on

2021-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	BVN Ablation Arm Per protocol successfully treated United States participants randomized to BVN Ablation arm in the original SMART RCT
Overall Study STARTED	117
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	BVN Ablation Arm Per protocol successfully treated United States participants randomized to BVN Ablation arm in the original SMART RCT
Overall Study Death	3
Overall Study Lost to Follow-up	10
Overall Study Withdrawal by Subject	3
Overall Study Refused participation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BVN Ablation Arm n=100 Participants Randomized and successfully treated with basivertebral nerve ablation
Age, Continuous	47.2 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants
Baseline Oswestry Disability Index (ODI)	42.8 units on a scale STANDARD_DEVIATION 11.6 • n=5 Participants
Baseline Visual Analog Scale (VAS)	6.73 units on a scale STANDARD_DEVIATION 1.43 • n=5 Participants

PRIMARY outcome

Timeframe: Difference between baseline and 5 year post treatment measurements

Population: US per protocol BVN ablation treated participants who consented to participate

Outcome measures

Outcome measures
Measure	BVN Ablation Arm n=100 Participants Randomized and successfully treated with basivertebral nerve ablation
LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline	25.95 units on a scale of 0 to 100 points Standard Deviation 18.54

SECONDARY outcome

Timeframe: Difference between baseline and 5 year post treatment measurements

Population: US per protocol BVN ablation treated participants who consented to participate

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.

Outcome measures

Outcome measures
Measure	BVN Ablation Arm n=100 Participants Randomized and successfully treated with basivertebral nerve ablation
LS Mean Reduction in VAS From Baseline	4.38 score on a scale of 0 to 10 Standard Deviation 2.35

SECONDARY outcome

Timeframe: At 5 year post treatment

Population: US per protocol BVN ablation treated participants who consented to participate

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.

Outcome measures

Outcome measures
Measure	BVN Ablation Arm n=100 Participants Randomized and successfully treated with basivertebral nerve ablation
Responder Rates	75 Participants

SECONDARY outcome

Timeframe: Difference between baseline and 5 years post treatment.

Population: US per protocol BVN ablation treated participants that consented to participate

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.

Outcome measures

Outcome measures
Measure	BVN Ablation Arm n=100 Participants Randomized and successfully treated with basivertebral nerve ablation
Narcotics Use	8 Participants

SECONDARY outcome

Timeframe: Difference from baseline percentage measurement to 5 years post treatment measurement

Population: US per protocol BVN ablation treated participants that consented to participate

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.

Outcome measures

Outcome measures
Measure	BVN Ablation Arm n=100 Participants Randomized and successfully treated with basivertebral nerve ablation
Injections	1 Participants

SECONDARY outcome

Timeframe: Measured form treatment data to 5 years post treatment visit date

Population: US per protocol BVN ablation treated participants that consented to participate

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.

Outcome measures

Outcome measures
Measure	BVN Ablation Arm n=100 Participants Randomized and successfully treated with basivertebral nerve ablation
Interventions	11 Participants

Adverse Events

BVN Ablation Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Diane Sahr, VP of Clinical Research

Relievant Medsystems

Phone: (650) 368-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place