Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Low Back Pain

Keywords

Vertebrogenic chronic low back painIntraosseous basivertebral nerve ablationLow back painAxial low back pain

Outcome Measures

Primary Outcomes (1)

Mean Change in ODI From Baseline to 5 Years Post Intracept Procedure
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.
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.

Secondary Outcomes (2)

Mean Change in Oswestry Disability Index (ODI) From Baseline to 3 Years Post Intracept Procedure
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.
Mean Change in ODI From Baseline to 4 Years Post Intracept Procedure
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.

Study Arms (1)

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

Interventions

Intracept ProcedureDevice

Intraosseous Basivertebral Nerve (BVN) Ablation

Basivertebral nerve ablation treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age25 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

\- 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)"

Sponsors & Collaborators

Boston Scientific Corporation
Industrylead

Study Sites (2)

Indiana Spine Group

Carmel, Indiana, 46032, United States

Seton Healthcare Family

Austin, Texas, 78731, United States

Related Publications (2)

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.
PMID: 31115683RESULT
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.
PMID: 35141598RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Sr. Director, Clinical Operations
Organization: Boston Scientific Corporation

Study Officials

Natalie Bloom Lyons
Boston Scientific Corporation
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

42 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 26, 2022

Study Start

February 16, 2022

Actual (reported)

CLBP Single-Arm Long-Term Follow-up Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Basivertebral nerve ablation treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Basivertebral nerve ablation treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations