CLBP Single-Arm Long-Term Follow-up Study

A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain Long-term Follow Up

This is a prospective, noninterventional, observational post market data collection of long-term effectiveness and satisfaction outcomes for "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Study)" population at three (3), four (4), and five (5) years post Intracept Procedure. The working hypothesis is that data collected in this study will demonstrate safety, efficacy, durability and reproducibility of BVN ablation treatment outcomes out to 3, 4, and 5-years post-procedure.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: Intracept Procedure

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana Spine Group
  • Texas
    • Austin, Texas, United States, 78731
      • Seton Healthcare Family

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

47 subjects treated in original CLBP Single-Arm Study will be given the option to participate in the study.

Description

Inclusion Criteria:

- Patient received the Intracept procedure while participating in "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Long-Term Study)"

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Basivertebral nerve ablation treatment; Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study.	Device: Intracept Procedure; Intraosseous Basivertebral Nerve (BVN) Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean improvement in Oswestry Disability Index (ODI) from baseline to 3 years post Intracept procedure	Oswestry Disability Index (100-point scale, "0" being the least disability and "100" being the worst degree of disability/function)	Difference between baseline and 3-year post treatment measurements.
Mean improvement in ODI from baseline to 4 years post Intracept procedure		Difference between baseline and 4-year post treatment measurements.
Mean improvement in ODI from baseline to 5 years post Intracept procedure		Difference between baseline and 5-year post treatment measurements.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean reduction in patient-reported numeric pain score from baseline for each timepoint.	10-point Numeric pain score (based on VAS): "0" representing no pain and "10" representing the worst pain imaginable.	3+ years, 4-years and 5-years post procedure
Responder rates for ODI: proportion of subjects who achieve ≥ 10-Point, ≥ 15-point and ≥ 20-point reduction in ODI from baseline for each timepoint		3+ years, 4-years and 5-years post procedure
Responder rates for Numeric Pain Score: proportion of subjects who achieve a ≥ 2.0-point reduction in NPS from baseline for each timepoint		3+ years, 4-years and 5-years post procedure
Number and proportion of subjects in each quartile (≤ 24%, 25-49%, 50-74%, 75-100%) for percent Numeric Pain Score reduction (in LBP) from baseline for each timepoint		3+ years, 4-years and 5-years post procedure
Composite responder rate at each timepoint defined as: 1) ODI decrease of ≥ 15 2) NPS decrease of ≥ 2		3+ years, 4-years and 5-years post procedure
Composite endpoint of long-term treatment success at each timepoint defined as:	ODI decrease of ≥15; NPS decrease of ≥2; No injections for the same low back pain etiology and location as treatment location; No pain intervention or surgery for the same low back pain etiology and location as treatment location	3+ years, 4-years and 5-years post procedure
The number and proportion of subjects with surgical interventions for low back pain of the same treatment region post the Intracept procedure at each timepoint		3+ years, 4-years and 5-years post procedure
The number and proportion of subjects actively utilizing (defined as >25% of total dosage in 30 days prior to study visit) opioids for low back pain of the same treatment region at each timepoint		3+ years, 4-years and 5-years post procedure
Work impact: number of missed workdays in past 30 days at each timepoint		3+ years, 4-years and 5-years post procedure
Patient satisfaction with the Intracept Procedure at each timepoint	Non-validated questionnaire about degree of improvement (improved, no change, worsened), satisfaction with treatment (yes/no) and willingness to repeat the treatment (yes/no).	3+ years, 4-years and 5-years post procedure
Work impact: number of days in bed in past 30 days		3+ years, 4-years and 5-years post procedure
Composite responder rate at each timepoint defined as: 1) ODI decrease of ≥ 15 2) NPS decrease of greater than or equal to 50%		3+ years, 4-years and 5-years post procedure
The number and proportion of subjects utilizing therapeutic injections since the last study visit for low back pain of the same treatment region at each timepoint		3+ years, 4-years and 5-years post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing safety	Serious adverse events potentially related to the procedure, device, or the spine will be reported and evaluated for relatedness	3+ years, 4-years and 5-years post procedure

Collaborators and Investigators

• Sponsor: Relievant Medsystems, Inc.
• Collaborators: M Squared Associates,Inc.; ProPharma Group
• Investigators: Principal Investigator: Eeric Truumees, MD, Seton Spine and Scoliosis Center; Principal Investigator: Kevin Macadaeg, MD, Indiana Spine Group

Publications and helpful links

General Publications

• Truumees E, Macadaeg K, Pena E, Arbuckle J 2nd, Gentile J 2nd, Funk R, Singh D, Vinayek S. A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Eur Spine J. 2019 Jul;28(7):1594-1602. doi: 10.1007/s00586-019-05995-2. Epub 2019 May 21.
• Macadaeg K, Truumees E, Boody B, Pena E, Arbuckle J 2nd, Gentile J, Funk R, Singh D, Vinayek S. A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. N Am Spine Soc J. 2020 Sep 18;3:100030. doi: 10.1016/j.xnsj.2020.100030. eCollection 2020 Oct. Erratum In: N Am Spine Soc J. 2020 Dec 01;4:100039.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Low back pain; Vertebrogenic chronic low back pain; Intraosseous basivertebral nerve ablation; Axial low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CP0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No