Trial Outcomes & Findings for Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain (NCT NCT03266107)

NCT ID: NCT03266107

Last Updated: 2020-12-22

Results Overview

Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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). The minimally clinically important difference in ODI from baseline is considered to be a 10 points reduction from baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-12-22

Participant Flow

Patients for the study were drawn from current low back pain clinic populations, referrals, and patient self-referral at two investigative sites in the U.S. from February 2018 to February 2019. Consecutively identified patients were screened for medical history and review of MRI for Modic/endplate changes and any excluded pain sources.

Participant milestones

Measure	Treatment Intracept - Intraosseous radiofrequency ablation of the basivertebral nerve using the Intracept System
Enrollment to Procedure STARTED	50
Enrollment to Procedure COMPLETED	47
Enrollment to Procedure NOT COMPLETED	3
3-Month Follow-up Visit STARTED	47
3-Month Follow-up Visit COMPLETED	46
3-Month Follow-up Visit NOT COMPLETED	1
12-Month Follow-up Visit STARTED	46
12-Month Follow-up Visit COMPLETED	45
12-Month Follow-up Visit NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment Intracept - Intraosseous radiofrequency ablation of the basivertebral nerve using the Intracept System
Enrollment to Procedure Failure to Access Due to Hardened Bone	1
Enrollment to Procedure Study stopped prior to Procedure	2
3-Month Follow-up Visit Lost to Follow-up	1
12-Month Follow-up Visit Lost to Follow-up	1

Baseline Characteristics

Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain

Baseline characteristics by cohort

Measure	Treatment n=47 Participants Intracept Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System
Age, Continuous	44.47 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	22 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	1 Participants n=5 Participants
Race (NIH/OMB) White	46 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	47 participants n=5 Participants
Baseline Oswestry Disability Index (ODI)	47.13 Total score on a scale of 0 to 100 STANDARD_DEVIATION 9.87 • n=5 Participants
Baseline Visual Analog Scale (VAS) for Low Back Pain	6.82 Scale 0 to 10 STANDARD_DEVIATION 1.03 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Basivertebral nerve ablation treated participants

Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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). The minimally clinically important difference in ODI from baseline is considered to be a 10 points reduction from baseline.

Outcome measures

Measure	Treatment n=46 Participants BVN Ablation Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System
Oswestry Disability Index (ODI) - 3 Months	-30.33 units on a scale Standard Deviation 12.71

SECONDARY outcome

Timeframe: 3 Months

Population: Basivertebral nerve ablation treated participants with a 3 month visit

Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline.

Outcome measures

Measure	Treatment n=46 Participants BVN Ablation Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System
Visual Analog Scale (VAS) - 3 Months	-3.79 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 3 Months

Population: Basivertebral nerve ablation treated participants with a 3 month visit

Number & percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. 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). The minimally clinically important difference for this tool is considered to be 10 points.

Outcome measures

Measure	Treatment n=46 Participants BVN Ablation Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System
ODI Responder Rate - 3-Month	42 Participants

SECONDARY outcome

Timeframe: 3 Months

Population: Basivertebral nerve ablation treated participants with a 3 month follow-up visit

Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.

Outcome measures

Measure	Treatment n=46 Participants BVN Ablation Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System
VAS Responder Rate - 3 Month	36 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Basivertebral nerve ablation treated participants with a 12 month visit

Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score is 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). The minimally clinically important difference for this tool is considered to be 10 point reduction in ODI.

Outcome measures

Measure	Treatment n=45 Participants BVN Ablation Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System
ODI -12 Months	-32.31 units on a scale Standard Deviation 14.07

SECONDARY outcome

Timeframe: 12 Months

Population: Basivertebral nerve ablation treated participants with 12-month follow-up visit

Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.

Outcome measures

Measure	Treatment n=45 Participants BVN Ablation Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System
VAS - 12 Month	-4.31 units on a scale Standard Deviation 2.51

SECONDARY outcome

Timeframe: 12 Months

Population: Basivertebral ablation treated participants with a 12 month follow-up visit

Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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). The minimally clinically important difference for this tool is considered to be 10 points.

Outcome measures

Measure	Treatment n=45 Participants BVN Ablation Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System
ODI Responder Rate - 12-Month	40 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Basivertebral nerve ablation treated participants with a 12 month follow-up visit

Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score.

Outcome measures

Measure	Treatment n=45 Participants BVN Ablation Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System
VAS Responder Rate - 12 Months	36 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Basivertebral nerve ablation treated participants with a 12 month follow-up visit

Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months.

Outcome measures

Measure	Treatment n=45 Participants BVN Ablation Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System
VAS Reduction 50% or More - 12 Month	31 Participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=47 participants at risk BVN Ablation Radiofrequency ablation of the basivertebral nerve using the Intracept System
Musculoskeletal and connective tissue disorders Radiculitis	4.3% 2/47 • Number of events 2 • 12 months

Additional Information

VP Clinical Affairs

Relievant Medsystems Inc.

Phone: (650) 368-1000

Email: dsahr@relievant.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place