Trial Outcomes & Findings for CLBP Single-Arm Long-Term Follow-up Study (NCT NCT05207813)

Results Overview

The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points.

Recruitment status

COMPLETED

Target enrollment

42 participants

Primary outcome timeframe

Difference between baseline and 5-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 5-years post Intracept Procedure data collected through this NCT record/study.

Results posted on

2025-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Basivertebral Nerve Ablation Treatment Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study. Intracept Procedure: Intraosseous Basivertebral Nerve (BVN) Ablation
Overall Study STARTED	42
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Basivertebral Nerve Ablation Treatment Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study. Intracept Procedure: Intraosseous Basivertebral Nerve (BVN) Ablation
Overall Study Lost to Follow-up	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Basivertebral Nerve Ablation Treatment n=40 Participants Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study. Intracept Procedure: Intraosseous Basivertebral Nerve (BVN) Ablation
Age, Continuous	45.75 years STANDARD_DEVIATION 8.53 • n=40 Participants
Sex: Female, Male Female	23 Participants n=40 Participants
Sex: Female, Male Male	17 Participants n=40 Participants
Region of Enrollment United States	40 participants n=40 Participants
Oswestry Disability Index (ODI)	47.05 score on a scale STANDARD_DEVIATION 10.17 • n=40 Participants

PRIMARY outcome

Timeframe: Difference between baseline and 5-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 5-years post Intracept Procedure data collected through this NCT record/study.

Population: Patients who completed all long-term follow-up visits (3-, 4-, 5-year follow-up visit).

The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points.

Outcome measures

Outcome measures
Measure	Basivertebral Nerve Ablation Treatment n=40 Participants Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study. Intracept Procedure: Intraosseous Basivertebral Nerve (BVN) Ablation
Mean Change in ODI From Baseline to 5 Years Post Intracept Procedure	34.63 units on a scale Standard Deviation 10.12

SECONDARY outcome

Timeframe: Difference between baseline and 3-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 3-years post Intracept Procedure data collected through this NCT record/study.

Population: Patients who completed all long-term follow-up visits (3-, 4-, 5-year follow-up visit).

The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points.

Outcome measures

Outcome measures
Measure	Basivertebral Nerve Ablation Treatment n=40 Participants Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study. Intracept Procedure: Intraosseous Basivertebral Nerve (BVN) Ablation
Mean Change in Oswestry Disability Index (ODI) From Baseline to 3 Years Post Intracept Procedure	33.25 units on a scale Standard Deviation 10.75

SECONDARY outcome

Timeframe: Difference between baseline and 4-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 4-years post Intracept Procedure data collected through this NCT record/study.

Population: Patients who completed all long-term follow-up visits (3-, 4-, 5-year follow-up visit).

The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points.

Outcome measures

Outcome measures
Measure	Basivertebral Nerve Ablation Treatment n=40 Participants Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study. Intracept Procedure: Intraosseous Basivertebral Nerve (BVN) Ablation
Mean Change in ODI From Baseline to 4 Years Post Intracept Procedure	34.50 units on a scale Standard Deviation 12.26

Adverse Events

Basivertebral Nerve Ablation Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sr. Director, Clinical Operations

Boston Scientific Corporation

Phone: 855-213-9890

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
Publication restrictions are in place

Restriction type: OTHER