Clinical trial NCT05660512: Intracept Intraosseous Basivertebral Nerve Ablation
Official title: A Prospective Single Arm Cohort Study of Intraosseous Basivertebral Nerve Ablation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Low Back Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the single study site who are offered an Intracept Procedure are eligible and will be approached to participate in this study. Up to 150 participants who are planning to be treated with the Intracept Procedure will be consented and ultimately, 50 participants with 12 months of follow-up data will be followed.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Disability Index (ODI) Change
timeFrame: 3 months
Secondary outcomes:
measure: Oswestry Disability Index (ODI) Change
timeFrame: 12 months
measure: Oswestry Disability Index (ODI) Change
timeFrame: 24 months
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 3 months
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 12 months
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 24 months
measure: Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)
timeFrame: 3 months
measure: Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)
timeFrame: 12 months
measure: Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)
timeFrame: 24 months
measure: PROMIS 29 Change
timeFrame: 3 months
measure: PROMIS 29 Change
timeFrame: 12 months
measure: PROMIS 29 Change
timeFrame: 24 months
measure: Quadrants of % reduction in low back pain from baseline to each follow-up period.
timeFrame: 3 months
measure: Quadrants of % reduction in low back pain from baseline to each follow-up period.
timeFrame: 12 months
measure: Quadrants of % reduction in low back pain from baseline to each follow-up period.
timeFrame: 24 months
measure: Responder rates for Oswestry Disability Index (ODI)
timeFrame: 3 months
measure: Responder rates for Oswestry Disability Index (ODI)
timeFrame: 12 months
measure: Responder rates for Oswestry Disability Index (ODI)
timeFrame: 24 months
measure: Responder rates for the Numeric Pain Rating Scale (NPRS)
timeFrame: 3 Months
measure: Responder rates the Numeric Pain Score
timeFrame: 12 Months
measure: Responder rates for the Numeric Pain Score
timeFrame: 24 Months
measure: Narcotic use
timeFrame: 3 Months
measure: Narcotic use
timeFrame: 12 Months
measure: Narcotic use
timeFrame: 24 Months
measure: Low back pain injections
timeFrame: 3 Months
measure: Low back pain injections
timeFrame: 12 Months
measure: Low back pain injections
timeFrame: 24 Months
measure: Low back pain interventions or surgery
timeFrame: 3 Months
measure: Low back pain interventions or surgery
timeFrame: 12 Months
measure: Low back pain interventions or surgery
timeFrame: 24 Months
measure: Work Impact
timeFrame: 12 Months
measure: Patient Global Impression of Change (PGIC)
timeFrame: 3 Months
measure: Patient Global Impression of Change (PGIC)
timeFrame: 12 Months
measure: Patient Global Impression of Change (PGIC)
timeFrame: 24 Months
measure: Patient-reported procedure-related adverse events
timeFrame: 3 Months
measure: Patient-reported procedure-related adverse events
timeFrame: 12 Months
measure: Patient-reported procedure-related adverse events
timeFrame: 24 Months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Utah Farmington Health Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
city: South Jordan
country: United States
facility: University of Utah South Jordan Health Center
state: Utah
Study officials:
References:
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