Trial Outcomes & Findings for INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP (NCT NCT03246061)

Last Updated: 2024-04-02

Results Overview

Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured 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 a 10 point reduction in ODI from a baseline in a patient. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.

Recruitment status

COMPLETED

Study phase

Target enrollment

140 participants

Primary outcome timeframe

3 months

Results posted on

2024-04-02

Participant Flow

420 patients screened for MRI Modic changes at levels L3 to S1 to achieve 140 enrollments. Patients with Modic changes at other levels or who had other primary etiologies for their low back pain (i.e. disc herniation, stenosis, facet joint) were excluded. An independent orthopedic surgeon medical reviewer confirmed eligibility prior to randomization. A pre-specified interim analysis was conducted when 60% of randomized patients completed their 3-month primary endpoint visit.

Participant milestones

Participant milestones
Measure	Basivertebral Nerve (BVN) Ablation BVN ablation with non-surgical standard care Intracept System: BVN ablation	Standard Care Control Continue with non-surgical standard care
Overall Study STARTED	66	74
Overall Study Interim Analysis	51	53
Overall Study COMPLETED	51	53
Overall Study NOT COMPLETED	15	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Basivertebral Nerve (BVN) Ablation BVN ablation with non-surgical standard care Intracept System: BVN ablation	Standard Care Control Continue with non-surgical standard care
Overall Study Still in follow-up	15	21

Baseline Characteristics

INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Basivertebral Nerve (BVN) Ablation n=51 Participants BVN ablation with standard care Intracept System: BVN ablation	Standard Care Control n=53 Participants Continue standard care	Total n=104 Participants Total of all reporting groups
Age, Continuous	50.0 years STANDARD_DEVIATION 9.0 • n=5 Participants	50.0 years STANDARD_DEVIATION 11.1 • n=7 Participants	50.0 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	51 Participants n=5 Participants	53 Participants n=7 Participants	104 Participants n=5 Participants
Baseline Oswestry Disability Index (ODI)	44.0 units on a scale STANDARD_DEVIATION 11.8 • n=5 Participants	48.1 units on a scale STANDARD_DEVIATION 11.2 • n=7 Participants	46.1 units on a scale STANDARD_DEVIATION 11.3 • n=5 Participants
Baseline Visual Analogue Scale (VAS)	6.51 units on a scale of 0 to 10 STANDARD_DEVIATION 1.31 • n=5 Participants	6.82 units on a scale of 0 to 10 STANDARD_DEVIATION 1.34 • n=7 Participants	6.67 units on a scale of 0 to 10 STANDARD_DEVIATION 1.33 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Interim Analysis N=104 (pre-specified interim analysis when approximately 60% of randomized participants complete their 3-month primary endpoint

Outcome measures

Outcome measures
Measure	Basivertebral Never (BVN) Ablation n=51 Participants BVN ablation with standard care Intracept System: RF ablation	Standard Care Control n=53 Participants Continue with standard care
Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)	-25.3 units on a scale Interval -29.6 to -21.0	-4.4 units on a scale Interval -8.7 to -0.2

SECONDARY outcome

Timeframe: 3 months post treatment / randomization

Population: Interim Analysis population

Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.

Outcome measures

Outcome measures
Measure	Basivertebral Never (BVN) Ablation n=51 Participants BVN ablation with standard care Intracept System: RF ablation	Standard Care Control n=53 Participants Continue with standard care
Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)	-3.46 units on a scale Interval -4.1 to -2.82	-1.02 units on a scale Interval -1.66 to -0.37

Adverse Events

BVN Ablation

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Standard Care Control

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BVN Ablation n=66 participants at risk BVN ablation with continued standard care Intracept System: BVN ablation using radiofrequency energy	Standard Care Control n=74 participants at risk Continue with non-surgical standard care Standard Care: Non-surgical standard care
Musculoskeletal and connective tissue disorders Transient Leg Pain	13.6% 9/66 • Number of events 9 • Enrollment through 24 month follow-up	2.7% 2/74 • Number of events 2 • Enrollment through 24 month follow-up
Renal and urinary disorders Urinary Retention	1.5% 1/66 • Number of events 1 • Enrollment through 24 month follow-up	0.00% 0/74 • Enrollment through 24 month follow-up
Musculoskeletal and connective tissue disorders Incisional Pain	1.5% 1/66 • Number of events 1 • Enrollment through 24 month follow-up	0.00% 0/74 • Enrollment through 24 month follow-up
Musculoskeletal and connective tissue disorders Ongoing low back pain	4.5% 3/66 • Number of events 3 • Enrollment through 24 month follow-up	4.1% 3/74 • Number of events 3 • Enrollment through 24 month follow-up
Musculoskeletal and connective tissue disorders Disc Herniation	1.5% 1/66 • Number of events 1 • Enrollment through 24 month follow-up	1.4% 1/74 • Number of events 1 • Enrollment through 24 month follow-up
Musculoskeletal and connective tissue disorders Incomplete Procedure	1.5% 1/66 • Number of events 1 • Enrollment through 24 month follow-up	0.00% 0/74 • Enrollment through 24 month follow-up

Additional Information

Chris Hilker, Sr. Director Clinical Affairs

Relievant Medsystems

Phone: (650) 368-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place