Chronic Low Back Pain
Conditions
Brief summary
Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting
Detailed description
This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.
Interventions
Radiofrequency ablation using 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
Yes
Inclusion criteria
* Skeletally mature subjects age 25-70 years, inclusive * Chronic lower back pain for at least six months * Failure to respond to at least six months of non-operative conservative management * Oswestry Disability Index (ODI) at time of evaluation of at least 30 points * Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1
Exclusion criteria
* Radicular pain by history or evidence of pain neurological deficit within the past one year. * Previous surgery performed on the lumbar spine * Current or history of symptomatic spinal stenosis * Current or history of osteoporotic or tumor-related vertebral body compression fracture * Current or history of vertebral cancer or spinal metastasis * Current or history of spinal infection * Metabolic bone disease * BMI greater or equal to 40 * Any radiographic evidence of other important back pathology * MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1 * Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain * Subjects who are bed bound * Demonstrates 3 or more Waddell's signs of Inorganic Behavior * Any evidence of current systemic infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | 3 months | Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment. Scale is measured from 0 to 100, better to worse respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 3, 6, 9, and 12 months | Mean change in Visual Analog Scale (VAS) pain score from baseline to 3, 6, 9 and 12 months post-treatment. Scale is measured from 0 to 10, better to worse respectively. |
| Oswestry Disability Index (ODI) | 6, 9, and 12 months | Mean change in Oswestry Disability Index (ODI) score from baseline to 6, 9 and 12 months post-treatment. Scale is measured from 0 to 100, better to worse respectively. |
Countries
United States
Outcome results
None listed