Intracept Intraosseous Basivertebral Nerve Ablation
Study Details
Study Description
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.
This study will be conducted according to Good Clinical Practice (GCP) guidelines, including participant verbal informed consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight.
Study design, conduct, analysis, and reporting are overseen by the Principal Investigator (PI) and the cross-specialty Independent Physician Steering Committee.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Participants in the study will have four study visits over a period of two years (one prior to procedure and 3 post their procedure). Study visits will be conducted via telephone by a third-party CRO and independent clinical research coordinators. Participants will be verbally consented and then evaluated via telephonic study visits at baseline (prior to procedure) and at 3, 12, and 24 months post their intraosseous basivertebral nerve ablation procedure.
Primary and secondary objectives are based on patient reported outcomes for functional improvement, pain reduction, and physical and mental health pre and post procedure. The study will also look at utilization of injections and pain interventions/surgery for treatment of low back pain post Intracept.
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- Oswestry Disability Index (ODI) Change [3 months]
Mean change in ODI scores from baseline (scale 0 to 100)
- Oswestry Disability Index (ODI) Change [12 months]
Mean change in ODI scores from baseline (scale 0 to 100)
- Oswestry Disability Index (ODI) Change [24 months]
Mean change in ODI scores from baseline (scale 0 to 100)
- Numeric Pain Score [3 months]
Mean change in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable)
- Numeric Pain Score [12 months]
Mean change in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable)
- Numeric Pain Score [24 months]
Mean change in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable)
- Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2) [3 months]
Percent of responders meeting both thresholds
- Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2) [12 months]
Percent of responders meeting both thresholds
- Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2) [24 months]
Percent of responders meeting both thresholds
- PROMIS 29 Change [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)])
- PROMIS 29 Change [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)])
- 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)])
- Injections utilization compared to baseline [3 months]
Numbers of injections post procedure compared to baseline
- Injections utilization compared to baseline [12 months]
Numbers of injections post procedure compared to baseline
- Injections utilization compared to baseline [24 months]
Numbers of injections post procedure compared to baseline
- Post ablation pain interventions/surgeries [3 months]
Numbers of pain interventions/surgeries post procedure compared to baseline
- Post ablation pain interventions/surgeries [12 months]
Numbers of pain interventions/surgeries post procedure compared to baseline
- Post ablation pain interventions/surgeries [24 months]
Numbers of pain interventions/surgeries post procedure compared to baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients scheduled for intraosseous basivertebral nerve ablation with the Intracept Procedure
Exclusion Criteria:
-
Not scheduled for an intraosseous basivertebral nerve ablation with the Intracept Procedure
-
Intracept procedure for different location other than low back pain
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Utah Farmington Health Center | Farmington | Utah | United States | 84025 |
| 2 | University of Utah Orthopaedic Center | Salt Lake City | Utah | United States | 84108 |
| 3 | University of Utah South Jordan Health Center | South Jordan | Utah | United States | 84009 |
Sponsors and Collaborators
- University of Utah
- Relievant Medsystems
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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, 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, 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Spine 2001 Apr 1;26(7):847.
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