To evaluate the safety and efficacy of radiofrequency (RF) ablation, in a Food and Drug Administration approved Investigational Device Exemption (IDE) trial, used to ablate the basivertebral nerve for the treatment of chronic low back pain (CLBP).
- Randomized, double-blind, sham-controlled
- Multi-Center: 15 US and 3 EU
- 225 Patients; Randomized to treatment (147) or sham (78) intervention
- Patients were evaluated preoperatively at 2 weeks and 6 weeks and 3, 6, 12 and 24 months postoperatively
- Skeletally mature patients with chronic (≥ 6 months), isolated lumbar pain who had not responded to at least 6 months of non-operative management
- All patients had Type 1 or Type 2 Modic changes of the treated vertebral bodies
- Primary Endpoint: Comparative change in Oswestry Disability Index (ODI) from baseline to 3 months
Treatment Arm (Per Protocol Population)
In the Intracept treatment arm, patients reported a 20.3 point mean improvement in ODI or a 48% decrease from their baseline score at 3 months. The improvement observed in the Intracept treatment arm was sustained through 12 and 24 months of follow-up.
Treatment Arm (Per Protocol Population n=128)
In the Intracept treatment arm, 75% of patients reported a 10 point or greater improvement in ODI and 48% of patients reported a 20 point or greater improvement in ODI.
Primary End Point; Change in ODI
(Per Protocol Population n=205)
Mean ODI improvement observed in the Intracept treatment arm was statistically superior compared to the control arm (p = 0.019).
There were no device-related serious adverse events. The rates of transpedicular access-related events were low and comparable between arms, as were neurological events. Imaging at 6 weeks and 6 months revealed no evidence of spinal cord abnormalities, avascular necrosis or accelerated disc degeneration.
Patients treated with Intracept for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher response rate than did the sham-treated controls. Intracept represents a minimally invasive treatment option for the relief of chronic low back pain.