Basivertebral Nerve Ablation With the Intracept Procedure

Low Back Pain Clinical Trial

Official title:

Prospective, Single-Arm, Cohort Study on Basivertebral Nerve Ablation With the Intracept Procedure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05692440
• Other study ID #: 20223348
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: May 3, 2021
• Est. completion date: June 1, 2026

Study information

• Verified date: March 2024
• Source: Neuro Spine and Pain Center of Key West
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site.

Description:

Participants in the study will have three study visits over a period of one-year (one prior to procedure and 2 post their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 1, 3, 6, and 12, and 24 months. Primary and secondary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index), low back pain reduction (Visual Analog Scale), and physical and mental health pre and post procedure (EQ-5D-5L and SF-36).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: June 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

Inclusion Criteria:

• Adult patients =18 years of age
• Patients who have experienced chronic low back pain for =6 months.
• Patients who have not responded to at least 6 months of conservative care.
• Patients with Modic type 1 or 2 changes.

Exclusion Criteria:

• Patients with severe cardiac or pulmonary disease.
• Patients with active systemic infection or localized infection in the treatment area.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Intracept Procedure
Intraosseous radiofrequency ablation of the basivertebral nerve

Locations

Country	Name	City	State
United States	Neuro Spine and Pain Center of Key West	Key West	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Neuro Spine and Pain Center of Key West

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI) Change- 6 Months	Validated questionnaire of low back pain related disability. Compromised of 10 questions evaluating the impact of low back pain on activities of daily living. The 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). Comparison of mean ODI baseline to 6 months.	6 Months
Secondary	Oswestry Disability Index (ODI) Change-12 Months	Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The 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). Comparison of mean ODI baseline to 6 months. The minimally clinically important difference is a 15-point reduction from baseline.	12 Months
Secondary	Visual Analog Scale (VAS)- 6 Months	Change in the mean visual analog scale (VAS) low back pain score from baseline to 6-months post treatment. VAS in a 10-point numeric scale with a 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 50% decrease in VAS from baseline.	6 Months
Secondary	Visual Analog Scale (VAS)- 12 Months	Change in the mean visual analog scale (VAS) low back pain score from baseline to 12-months post treatment. VAS is a 10-point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimally clinically important difference is a 50% decrease in VAS from baseline.	12 Months
Secondary	ODI Responder Rate- 6 Months	Number & percent of patients with greater than or equal to 15-point reduction in Oswestry Disability Index (ODI) from baseline to 6 months post treatment. ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimally 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 is a 15-point reduction from baseline.	6 Months
Secondary	ODI Responder Rate- 12 Months	Number & percent of patients with greater than or equal to 15-point reduction in Oswestry Disability Index (ODI) from baseline to 12 months post treatment. ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimally 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 is a 15-point reduction from baseline.	12 Months
Secondary	VAS Responder Rate- 6 Months	Number and percentage of participants with a greater than or equal to a 50% reduction from baseline in visual analog scale (VAS) for low back pain at 6 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 minimally clinically important difference in VAS from baseline is a 50% reduction.	6 Months
Secondary	VAS Responder Rate-12 Months	Number and percentage of participants with a greater than or equal to a 50% reduction from baseline in visual analog scale (VAS) for low back pain 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 50% reduction.	12 Months