An interventional study of Intracept in Chronic Low Back Pain, sponsored by Relievant Medsystems, Inc.. Completed at 2 sites in United States. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-22.
Sponsored by Relievant Medsystems, Inc. · Not applicable, Interventional, and Treatment
Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.
Exclusion Criteria:
BVN Ablation
Device: Intracept
Radiofrequency ablation of the basivertebral nerve using the Intracept System
Oswestry Disability Index (ODI) - 3 Months
Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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). The minimally clinically important difference in ODI from baseline is considered to be a 10 points reduction from baseline.
Time frame: 3 months
Visual Analog Scale (VAS) - 3 Months
Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline.
Time frame: 3 Months
ODI Responder Rate - 3-Month
Number \& percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. 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). The minimally clinically important difference for this tool is considered to be 10 points.
Time frame: 3 Months
VAS Responder Rate - 3 Month
Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.
Time frame: 3 Months
ODI -12 Months
Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score is 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). The minimally clinically important difference for this tool is considered to be 10 point reduction in ODI.
Time frame: 12 Months
VAS - 12 Month
Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.
Time frame: 12 Months
ODI Responder Rate - 12-Month
Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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). The minimally clinically important difference for this tool is considered to be 10 points.
Time frame: 12 Months
VAS Responder Rate - 12 Months
Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score.
Time frame: 12 Months
VAS Reduction 50% or More - 12 Month
Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months.
Time frame: 12 Months
Patients for the study were drawn from current low back pain clinic populations, referrals, and patient self-referral at two investigative sites in the U.S. from February 2018 to February 2019. Consecutively identified patients were screened for medical history and review of MRI for Modic/endplate changes and any excluded pain sources.
| Milestone | Treatment |
|---|---|
| Started | 50 |
| Completed | 47 |
| Not completed | 3 |
| Withdrew: Failure to access due to hardened bone | 1 |
| Withdrew: Study stopped prior to procedure | 2 |
| Milestone | Treatment |
|---|---|
| Started | 47 |
| Completed | 46 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
| Milestone | Treatment |
|---|---|
| Started | 46 |
| Completed | 45 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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). The minimally clinically important difference in ODI from baseline is considered to be a 10 points reduction from baseline.
| units on a scale | Treatment |
|---|---|
| Oswestry Disability Index (ODI) - 3 Months | -30.33 ± 12.71 |
Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline.
| units on a scale | Treatment |
|---|---|
| Visual Analog Scale (VAS) - 3 Months | -3.79 ± 2.2 |
Number \& percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. 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). The minimally clinically important difference for this tool is considered to be 10 points.
| Participants | Treatment |
|---|---|
| ODI Responder Rate - 3-Month | 42 |
Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.
| Participants | Treatment |
|---|---|
| VAS Responder Rate - 3 Month | 36 |
Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score is 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). The minimally clinically important difference for this tool is considered to be 10 point reduction in ODI.
| units on a scale | Treatment |
|---|---|
| ODI -12 Months | -32.31 ± 14.07 |
Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.
| units on a scale | Treatment |
|---|---|
| VAS - 12 Month | -4.31 ± 2.51 |
Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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). The minimally clinically important difference for this tool is considered to be 10 points.
| Participants | Treatment |
|---|---|
| ODI Responder Rate - 12-Month | 40 |
Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score.
| Participants | Treatment |
|---|---|
| VAS Responder Rate - 12 Months | 36 |
Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months.
| Participants | Treatment |
|---|---|
| VAS Reduction 50% or More - 12 Month | 31 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/47 (0%) | 0/47 (0%) | 2/47 (4.3%) |
| Event | Treatment |
|---|---|
| RadiculitisMusculoskeletal and connective tissue disorders | 2/47 |
Intracept treated population
| Age, Continuous(years) | Treatment |
|---|---|
| Mean | 44.47 ± 8.6 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 25 |
| Male | 22 |
| Race (NIH/OMB)(Participants) | Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 46 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment |
|---|---|
| United States | 47 |
| Baseline Oswestry Disability Index (ODI)(Total score on a scale of 0 to 100) | Treatment |
|---|---|
| Mean | 47.13 ± 9.87 |
| Baseline Visual Analog Scale (VAS) for Low Back Pain(Scale 0 to 10) | Treatment |
|---|---|
| Mean | 6.82 ± 1.03 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Results
Supporting information: Study protocol, Icf, Csr, Analytic code
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Relievant Medsystems, Inc.