Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05660512

Intracept Intraosseous Basivertebral Nerve Ablation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Farmington Health Center, Farmington, Utah, United States

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracept Procedure

Procedure

Radiofrequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain

Primary outcomes

  1. Oswestry Disability Index (ODI) Change

    Time frame: 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 outcomes

  1. Oswestry Disability Index (ODI) Change

    Time frame: 12 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.

  2. Oswestry Disability Index (ODI) Change

    Time frame: 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.

  3. Numeric Pain Rating Scale (NPRS)

    Time frame: 3 months

    Mean change in patient-reported low back pain from baseline. The scale is from 0 (no pain) to 10 (worst pain imaginable).

  4. Numeric Pain Rating Scale (NPRS)

    Time frame: 12 months

    Mean change in patient-reported low back pain from baseline. The scale is from 0 (no pain) to 10 (worst pain imaginable).

  5. Numeric Pain Rating Scale (NPRS)

    Time frame: 24 months

    Mean change in patient-reported low back pain from baseline. The scale is from 0 (no pain) to 10 (worst pain imaginable).

  6. Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)

    Time frame: 3 months

    Percent of responders meeting both thresholds

  7. Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)

    Time frame: 12 months

    Percent of responders meeting both thresholds

  8. Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)

    Time frame: 24 months

    Percent of responders meeting both thresholds

  9. PROMIS 29 Change

    Time frame: 3 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)])

  10. PROMIS 29 Change

    Time frame: 12 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)])

  11. PROMIS 29 Change

    Time frame: 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)])

  12. Quadrants of % reduction in low back pain from baseline to each follow-up period.

    Time frame: 3 months

    Review of the % of low back pain reduction in participants

  13. Quadrants of % reduction in low back pain from baseline to each follow-up period.

    Time frame: 12 months

    Review of the % of low back pain reduction in participants

  14. Quadrants of % reduction in low back pain from baseline to each follow-up period.

    Time frame: 24 months

    Review of the % of low back pain reduction in participants

  15. Responder rates for Oswestry Disability Index (ODI)

    Time frame: 3 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 3 months.

  16. Responder rates for Oswestry Disability Index (ODI)

    Time frame: 12 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 12 months.

  17. Responder rates for Oswestry Disability Index (ODI)

    Time frame: 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.

  18. Responder rates for the Numeric Pain Rating Scale (NPRS)

    Time frame: 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).

  19. Responder rates the Numeric Pain Score

    Time frame: 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).

  20. Responder rates for the Numeric Pain Score

    Time frame: 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).

  21. Narcotic use

    Time frame: 3 Months

    The proportion of patients actively utilizing narcotics for low back pain at each follow-up period.

  22. Narcotic use

    Time frame: 12 Months

    The proportion of patients actively utilizing narcotics for low back pain at each follow-up period.

  23. Narcotic use

    Time frame: 24 Months

    The proportion of patients actively utilizing narcotics for low back pain at each follow-up period.

  24. Low back pain injections

    Time frame: 3 Months

    The proportion of patients utilizing injections for low back pain of the same treatment region at each follow-up period.

  25. Low back pain injections

    Time frame: 12 Months

    The proportion of patients utilizing injections for low back pain of the same treatment region at each follow-up period.

  26. Low back pain injections

    Time frame: 24 Months

    The proportion of patients utilizing injections for low back pain of the same treatment region at each follow-up period.

  27. Low back pain interventions or surgery

    Time frame: 3 Months

    The proportion of patients with pain interventions or surgery for low back pain of the same treatment region at each follow-up period

  28. Low back pain interventions or surgery

    Time frame: 12 Months

    The proportion of patients with pain interventions or surgery for low back pain of the same treatment region at each follow-up period

  29. Low back pain interventions or surgery

    Time frame: 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

  30. Work Impact

    Time frame: 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?

  31. Patient Global Impression of Change (PGIC)

    Time frame: 3 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.

  32. Patient Global Impression of Change (PGIC)

    Time frame: 12 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.

  33. Patient Global Impression of Change (PGIC)

    Time frame: 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.

  34. Patient-reported procedure-related adverse events

    Time frame: 3 Months

    Patient-reported procedure-related adverse events including new LBP and/or leg pain at each follow-up period

  35. Patient-reported procedure-related adverse events

    Time frame: 12 Months

    Patient-reported procedure-related adverse events including new LBP and/or leg pain at each follow-up period

  36. Patient-reported procedure-related adverse events

    Time frame: 24 Months

    Patient-reported procedure-related adverse events including new LBP and/or leg pain at each follow-up period

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

A Prospective Single Arm Cohort Study of Intraosseous Basivertebral Nerve Ablation

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.