Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Device: Intracept

• Registration Number: NCT03266107
• Lead Sponsor: Relievant Medsystems, Inc.

Brief Summary

Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.

Detailed Description

This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.

Study Timeline

• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-29
• Study Start: 2018-02-14
• Primary Completion: 2020-02-17
• Study Completion: 2020-02-17
• Results First Submitted: 2020-11-02
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-21
• Last Update Submitted: 2020-12-21
• Results First Posted: 2020-12-22
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Skeletally mature subjects at least 25 years of age
• Chronic low back pain for at least 6 months
• Failure to respond to at least 6 months of non-operative conservative management
• Oswestry Disability Index (ODI) at least 30 points
• Modic changes Type 1 or 2

Exclusion Criteria

• Current or history of vertebral cancer or spinal metastasis
• History of a fragility fracture
• Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
• Disc extrusion or protrusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Intracept	BVN Ablation

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI) - 3 Months	3 months	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.

Secondary Outcome Measures

Name	Time	Method
VAS - 12 Month	12 Months	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.
ODI Responder Rate - 12-Month	12 Months	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.
ODI Responder Rate - 3-Month	3 Months	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.
VAS Responder Rate - 12 Months	12 Months	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.
Visual Analog Scale (VAS) - 3 Months	3 Months	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.
VAS Reduction 50% or More - 12 Month	12 Months	Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months.
VAS Responder Rate - 3 Month	3 Months	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.
ODI -12 Months	12 Months	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.

Trial Locations

Locations (2)

Indiana Spine Group; 🇺🇸 Carmel, Indiana, United States

Seton Spine and Scoliosis Center; 🇺🇸 Austin, Texas, United States