Chronic Low Back Pain
Conditions
Keywords
Vertebrogenic Low Back Pain
Brief summary
Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
Detailed description
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.
Interventions
DEVICEIntracept
Radiofrequency ablation of the basivertebral nerve using the Intracept System
Sponsors
Relievant Medsystems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Skeletally mature subjects at least 25 years of age * Chronic low back pain for at least 6 months * Failure to respond to at least 6 months of non-operative conservative management * Oswestry Disability Index (ODI) at least 30 points * Modic changes Type 1 or 2
Exclusion criteria
* Current or history of vertebral cancer or spinal metastasis * History of a fragility fracture * Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain * Disc extrusion or protrusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) - 3 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ODI Responder Rate - 3-Month | 3 Months | 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. |
| VAS Responder Rate - 3 Month | 3 Months | 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. |
| ODI -12 Months | 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. |
| Visual Analog Scale (VAS) - 3 Months | 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. |
| ODI Responder Rate - 12-Month | 12 Months | 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. |
| VAS Responder Rate - 12 Months | 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. |
| VAS Reduction 50% or More - 12 Month | 12 Months | Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months. |
| VAS - 12 Month | 12 Months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Intracept
Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12-Month Follow-up Visit | Lost to Follow-up | 1 |
| 3-Month Follow-up Visit | Lost to Follow-up | 1 |
| Enrollment to Procedure | Failure to Access Due to Hardened Bone | 1 |
| Enrollment to Procedure | Study stopped prior to Procedure | 2 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 44.47 years STANDARD_DEVIATION 8.6 |
| Baseline Oswestry Disability Index (ODI) | 47.13 Total score on a scale of 0 to 100 STANDARD_DEVIATION 9.87 |
| Baseline Visual Analog Scale (VAS) for Low Back Pain | 6.82 Scale 0 to 10 STANDARD_DEVIATION 1.03 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 2 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
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
Population: Basivertebral nerve ablation treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Oswestry Disability Index (ODI) - 3 Months | -30.33 units on a scale | Standard Deviation 12.71 |
p-value: <0.001t-test, 1 sided
Secondary
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
Population: Basivertebral nerve ablation treated participants with a 12 month visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | ODI -12 Months | -32.31 units on a scale | Standard Deviation 14.07 |
p-value: <0.001t-test, 1 sided
Secondary
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
Population: Basivertebral ablation treated participants with a 12 month follow-up visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | ODI Responder Rate - 12-Month | 40 Participants |
Secondary
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
Population: Basivertebral nerve ablation treated participants with a 3 month visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | ODI Responder Rate - 3-Month | 42 Participants |
Secondary
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
Population: Basivertebral nerve ablation treated participants with 12-month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | VAS - 12 Month | -4.31 units on a scale | Standard Deviation 2.51 |
Secondary
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
Population: Basivertebral nerve ablation treated participants with a 12 month follow-up visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | VAS Reduction 50% or More - 12 Month | 31 Participants |
Secondary
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
Population: Basivertebral nerve ablation treated participants with a 12 month follow-up visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | VAS Responder Rate - 12 Months | 36 Participants |
Secondary
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
Population: Basivertebral nerve ablation treated participants with a 3 month follow-up visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | VAS Responder Rate - 3 Month | 36 Participants |
Secondary
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
Population: Basivertebral nerve ablation treated participants with a 3 month visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Visual Analog Scale (VAS) - 3 Months | -3.79 units on a scale | Standard Deviation 2.2 |
p-value: <0.001t-test, 1 sided