Intracept Intraosseous Basivertebral Nerve Ablation

Active, not recruiting

• Conditions: Low Back Pain

• Registration Number: NCT05660512
• Lead Sponsor: University of Utah

Brief Summary

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

Detailed Description

The Investigator Sponsor will initially approach patients planning to undergo the Intracept Procedure to discuss their interest in learning more about the study. With patient permission, contact information will be forwarded to a third-party research organization which will contact the patient to explain more about the study and to gather Verbal Informed Consent.

Study data will be collected by the University of Utah research staff via 4 telephone study visits under the direction of the Sponsor Investigator. The study research staff will enter the study data directly into a study database and issue the subject stipend after the completion of each study visit.

Data will be analyzed by a statistician under the direction of the Sponsor Investigator for this single-site study.

Study Timeline

• Study Start: 2020-07-27
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-10
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• All patients scheduled for intraosseous basivertebral nerve ablation with the Intracept Procedure
• OR Participant had an Intracept Procedure for their low back pain and completed standard of care questionnaires at their procedure appointment.

Exclusion Criteria

• Not scheduled for an intraosseous basivertebral nerve ablation with the Intracept Procedure
• Intracept procedure for different location other than low back pain

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quadrants of % reduction in low back pain from baseline to each follow-up period.	24 months	Review of the % of low back pain reduction in participants
Responder rates for the Numeric Pain Rating Scale (NPRS)	3 Months	The proportion of subjects who achieve a ≥ 2-point reduction in the NPRS from baseline to each follow-up period. The scale is from 0 (no pain) to 10 (worst pain imaginable).
PROMIS 29 Change	24 months	Mean change in PROMIS-29 from baseline. (PROMIS-29 includes Numeric Rating Score (NRS) and Seven Health Domains. \[NRS 0-10 zero being none and 10 the worst. Seven health domains scaled 1-5: physical function (1 unable to do to 5 without any difficulty), fatigue (1 not at all and 5 very much), pain interference (1 not at all and 5 very much), depressive symptoms (1 never and 5 always), anxiety (1 never and 5 always), ability to participate in social roles and activities (1 never and 5 always), and sleep disturbance(1 not at all and 5 very much)\])
Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)	24 months	Percent of responders meeting both thresholds
Responder rates for Oswestry Disability Index (ODI)	24 months	The proportion of subjects who achieve ≥ 15-point reduction in ODI from baseline to each follow-up period. This would indicate a reduction in how much lower back pain is affecting participants' daily activities following the procedure.; The Oswestry Disability Index (ODI) is a 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 24 months.
Low back pain interventions or surgery	24 Months	The proportion of patients with pain interventions or surgery for low back pain of the same treatment region at each follow-up period
Patient Global Impression of Change (PGIC)	24 Months	PGIC at each follow-up period. The subject is asked to rate their low back pain progress with the scale: Very Much Improved; Much Improved; Minimally Improved; No Change; Minimally worse; Much Worse; Very Much Worse.
Patient-reported procedure-related adverse events	24 Months	Patient-reported procedure-related adverse events including new LBP and/or leg pain at each follow-up period
Oswestry Disability Index (ODI) Change	24 months	Mean improvement in ODI scores from baseline (scale 0 to 100): 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 3 months.
Numeric Pain Rating Scale (NPRS)	24 months	Mean change in patient-reported low back pain from baseline. The scale is from 0 (no pain) to 10 (worst pain imaginable).
Responder rates the Numeric Pain Score	12 Months	the proportion of subjects who achieve a ≥ 2-point reduction in numeric pain score from baseline to each follow-up period. The scale is from 0 (no pain) to 10 (worst pain imaginable).
Low back pain injections	24 Months	The proportion of patients utilizing injections for low back pain of the same treatment region at each follow-up period.
Responder rates for the Numeric Pain Score	24 Months	the proportion of subjects who achieve a ≥ 2-point reduction in numeric pain score from baseline to each follow-up period. The scale is from 0 (no pain) to 10 (worst pain imaginable).
Narcotic use	24 Months	The proportion of patients actively utilizing narcotics for low back pain at each follow-up period.
Work Impact	12 Months	Patient work status at 12 months indicated by subject using this scale: No impact to my ability to work; Working with restrictions; Had to get a different job due to low back pain; Unable to work at all/disabled by my low back pain (e.g. retired, unemployed); Not currently working unrelated to low back pain; Other.; If a subject is working with restrictions, they are asked to specify: Reduced hours; Slower pace; Less heavy work; Not regular job.; Subjects are also asked the question: How many workdays have you missed due to low back pain?

Trial Locations

Locations (3)

University of Utah South Jordan Health Center; 🇺🇸 South Jordan, Utah, United States

University of Utah Farmington Health Center; 🇺🇸 Farmington, Utah, United States

University of Utah Orthopaedic Center; 🇺🇸 Salt Lake City, Utah, United States