NCT05660512|Active Not Recruiting
Intracept Intraosseous Basivertebral Nerve Ablation
A Prospective Single Arm Cohort Study of Intraosseous Basivertebral Nerve Ablation
Loading search results
A Prospective Single Arm Cohort Study of Intraosseous Basivertebral Nerve Ablation
Sponsor study identifier
observational
150
1 country
3
Study Start
July 27, 2020
Actual (reported)Primary Completion
February 5, 2026
Actual (reported)Study Completion
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 27, 2020
Actual (reported)December 13, 2022
Actual (reported)December 21, 2022
Actual (reported)February 5, 2026
Actual (reported)July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
3 months
Oswestry Disability Index (ODI) Change
12 months
Oswestry Disability Index (ODI) Change
24 months
Numeric Pain Rating Scale (NPRS)
3 months
Numeric Pain Rating Scale (NPRS)
12 months
Numeric Pain Rating Scale (NPRS)
24 months
Radiofrequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University of Utah Farmington Health Center
Farmington, Utah, 84025, United States
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108, United States
University of Utah South Jordan Health Center
South Jordan, Utah, 84009, United States
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.
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.
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.
First Submitted
December 13, 2022
First Posted
December 21, 2022
Study Start
July 27, 2020
Actual (reported)Primary Completion
February 5, 2026
Actual (reported)CLBP Single-Arm Long-Term Follow-up Study
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Study Completion
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 13, 2026
Record last verified: 2026-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: