CLBP Single-Arm Long-Term Follow-up Study

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05207813
• Other study ID #: CP0015
• Status: Completed
• Start date: February 16, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Relievant Medsystems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Intracept Procedure
Intraosseous Basivertebral Nerve (BVN) Ablation

Locations

Country	Name	City	State
United States	Seton Healthcare Family	Austin	Texas
United States	Indiana Spine Group	Carmel	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Relievant Medsystems, Inc.	M Squared Associates,Inc., ProPharma Group

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. 20 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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.
Primary	Mean improvement in ODI from baseline to 4 years post Intracept procedure		Difference between baseline and 4-year post treatment measurements.
Primary	Mean improvement in ODI from baseline to 5 years post Intracept procedure		Difference between baseline and 5-year post treatment measurements.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Work impact: number of missed workdays in past 30 days at each timepoint		3+ years, 4-years and 5-years post procedure
Secondary	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
Secondary	Work impact: number of days in bed in past 30 days		3+ years, 4-years and 5-years post procedure