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Low Back PainNCT05660512

Intracept Intraosseous Basivertebral Nerve Ablation

An observational study of Low Back Pain, run by University of Utah at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain
What is being tested?
Intracept Procedure
Type of treatment
Surgery or procedure
How many people
150 participants
Where
3 sitesUnited States
Study dates
27 Jul 2020to Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Utah Farmington Health Center

    Farmington, Utah, 84025

  • University of Utah Orthopaedic Center

    Salt Lake City, Utah, 84108

  • University of Utah South Jordan Health Center

    South Jordan, Utah, 84009

Other trials in United States

About this study

Official title: A Prospective Single Arm Cohort Study of 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.

Read the 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.

Conditions
Low Back Pain
Being tested
Intracept Procedure
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracept ProcedureProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oswestry Disability Index (ODI) Change

    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.

    Measured: 3 months

Secondary outcomes (36)

  1. Oswestry Disability Index (ODI) Change

    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.

    Measured: 12 months

  2. Oswestry Disability Index (ODI) Change

    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.

    Measured: 24 months

  3. Numeric Pain Rating Scale (NPRS)

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

    Measured: 3 months

  4. Numeric Pain Rating Scale (NPRS)

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

    Measured: 12 months

  5. Numeric Pain Rating Scale (NPRS)

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

    Measured: 24 months

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

    Percent of responders meeting both thresholds

    Measured: 3 months

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

    Percent of responders meeting both thresholds

    Measured: 12 months

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

    Percent of responders meeting both thresholds

    Measured: 24 months

  9. PROMIS 29 Change

    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)])

    Measured: 3 months

  10. PROMIS 29 Change

    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)])

    Measured: 12 months

  11. PROMIS 29 Change

    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)])

    Measured: 24 months

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

    Review of the % of low back pain reduction in participants

    Measured: 3 months

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

    Review of the % of low back pain reduction in participants

    Measured: 12 months

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

    Review of the % of low back pain reduction in participants

    Measured: 24 months

  15. Responder rates for Oswestry Disability Index (ODI)

    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.

    Measured: 3 months

  16. Responder rates for Oswestry Disability Index (ODI)

    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.

    Measured: 12 months

  17. Responder rates for Oswestry Disability Index (ODI)

    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.

    Measured: 24 months

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

    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).

    Measured: 3 Months

  19. Responder rates the Numeric Pain Score

    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).

    Measured: 12 Months

  20. Responder rates for the Numeric Pain Score

    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).

    Measured: 24 Months

  21. Narcotic use

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

    Measured: 3 Months

  22. Narcotic use

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

    Measured: 12 Months

  23. Narcotic use

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

    Measured: 24 Months

  24. Low back pain injections

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

    Measured: 3 Months

  25. Low back pain injections

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

    Measured: 12 Months

  26. Low back pain injections

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

    Measured: 24 Months

  27. Low back pain interventions or surgery

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

    Measured: 3 Months

  28. Low back pain interventions or surgery

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

    Measured: 12 Months

  29. Low back pain interventions or surgery

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

    Measured: 24 Months

  30. Work Impact

    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?

    Measured: 12 Months

  31. Patient Global Impression of Change (PGIC)

    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.

    Measured: 3 Months

  32. Patient Global Impression of Change (PGIC)

    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.

    Measured: 12 Months

  33. Patient Global Impression of Change (PGIC)

    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.

    Measured: 24 Months

  34. Patient-reported procedure-related adverse events

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

    Measured: 3 Months

  35. Patient-reported procedure-related adverse events

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

    Measured: 12 Months

  36. Patient-reported procedure-related adverse events

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

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start27 Jul 2020
  3. Primary completion5 Feb 2026
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05660512
Sponsor's protocol ID
130205
Status last verified
Mar 2026
First submitted
13 Dec 2022
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lotz JC, Fields AJ, Liebenberg EC. The role of the vertebral end plate in low back pain. Global Spine J. 2013 Jun;3(3):153-64. doi: 10.1055/s-0033-1347298. Epub 2013 May 23.

    PubMed 24436866

  • Dudli S, Fields AJ, Samartzis D, Karppinen J, Lotz JC. Pathobiology of Modic changes. Eur Spine J. 2016 Nov;25(11):3723-3734. doi: 10.1007/s00586-016-4459-7. Epub 2016 Feb 25.

    PubMed 26914098

  • Munir S, Freidin MB, Rade M, Maatta J, Livshits G, Williams FMK. Endplate Defect Is Heritable, Associated With Low Back Pain and Triggers Intervertebral Disc Degeneration: A Longitudinal Study From TwinsUK. Spine (Phila Pa 1976). 2018 Nov 1;43(21):1496-1501. doi: 10.1097/BRS.0000000000002721.

    PubMed 29847371

  • Dudli S, Sing DC, Hu SS, Berven SH, Burch S, Deviren V, Cheng I, Tay BKB, Alamin TF, Ith MAM, Pietras EM, Lotz JC. ISSLS PRIZE IN BASIC SCIENCE 2017: Intervertebral disc/bone marrow cross-talk with Modic changes. Eur Spine J. 2017 May;26(5):1362-1373. doi: 10.1007/s00586-017-4955-4. Epub 2017 Jan 31.

    PubMed 28138783

  • Fras C, Kravetz P, Mody DR, Heggeness MH. Substance P-containing nerves within the human vertebral body. an immunohistochemical study of the basivertebral nerve. Spine J. 2003 Jan-Feb;3(1):63-7. doi: 10.1016/s1529-9430(02)00455-2.

    PubMed 14589248

  • Bailey JF, Liebenberg E, Degmetich S, Lotz JC. Innervation patterns of PGP 9.5-positive nerve fibers within the human lumbar vertebra. J Anat. 2011 Mar;218(3):263-70. doi: 10.1111/j.1469-7580.2010.01332.x. Epub 2011 Jan 12.

    PubMed 21223256

  • Fischgrund JS, Rhyne A, Franke J, Sasso R, Kitchel S, Bae H, Yeung C, Truumees E, Schaufele M, Yuan P, Vajkoczy P, DePalma M, Anderson DG, Thibodeau L, Meyer B. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2018 May;27(5):1146-1156. doi: 10.1007/s00586-018-5496-1. Epub 2018 Feb 8.

    PubMed 29423885

  • Fischgrund JS, Rhyne A, Franke J, Sasso R, Kitchel S, Bae H, Yeung C, Truumees E, Schaufele M, Yuan P, Vajkoczy P, Depalma M, Anderson DG, Thibodeau L, Meyer B. Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study. Int J Spine Surg. 2019 Apr 30;13(2):110-119. doi: 10.14444/6015. eCollection 2019 Apr.

    PubMed 31131209

  • Fischgrund JS, Rhyne A, Macadaeg K, Moore G, Kamrava E, Yeung C, Truumees E, Schaufele M, Yuan P, DePalma M, Anderson DG, Buxton D, Reynolds J, Sikorsky M. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020 Aug;29(8):1925-1934. doi: 10.1007/s00586-020-06448-x. Epub 2020 May 25.

    PubMed 32451777

  • Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.

    PubMed 11124727

  • Hagg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. doi: 10.1007/s00586-002-0464-0. Epub 2002 Oct 24.

    PubMed 12592542

  • Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

    PubMed 6226917

  • Ostelo RW, de Vet HC. Clinically important outcomes in low back pain. Best Pract Res Clin Rheumatol. 2005 Aug;19(4):593-607. doi: 10.1016/j.berh.2005.03.003.

    PubMed 15949778

  • McCormick ZL, Fogarty AE, Conger A, Burnham T, Kendall R, Dickenson BA, Kanjanapanang N, Curtis TM, Sen H, Glinka Przybysz A, Clark T, Smolinski K, Wagner G, Teramoto M, Cooper AN. The effectiveness of basivertebral nerve radiofrequency ablation for the treatment of vertebrogenic low back pain: 1-year results of a prospective real-world cohort study. Pain Med. 2026 Mar 1;27(3):254-261. doi: 10.1093/pm/pnaf122.

    PubMed 40891888

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by University of Utah at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (ODI) Change (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05660512, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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Intracept Intraosseous Basivertebral Nerve Ablation | AzTrials