Level l INTRACEPT Study

Demonstrates Highly Significant Results1


Purpose

To compare the effectiveness of the Intracept Procedure to standard care for the treatment of chronic vertebrogenic low back pain.


Study Design

  • Prospective, randomized, multi-center
  • 20 US sites
  • 104 Patients; Randomized to Intracept (51) or standard care (53)
  • Patients were evaluated at baseline and at 3, 6, 9, and 12 months post-treatment
  • Skeletally mature patients with low back pain ≥ 6 months who had not responded to at least 6 months of conservative care
  • All patients had Type 1 or Type 2 Modic changes at up to 4 vertebral bodies (L3-S1)
  • Primary Endpoint: Between-arm comparison of the mean change in ODI from baseline to 3 months post-treatment

Key Findings

Primary Endpoint; Change in ODI at 3 Months

In the Intracept arm, patients reported a 25.3 mean improvement in ODI at 3 months compared to patients reporting a 4.4 mean improvement in the standard care arm. The difference between arms of 20.9 was highly significant.

Change in VAS at 3 Months

In the Intracept arm, patients reported a 3.46 mean improvement in VAS at 3 months compared to patients reporting a 1.02 mean improvement in the standard care arm. The difference between arms of 2.44 was highly significant.

ODI Responder Rates – Baseline to 3 months

In the Intracept arm, responder rates at 3 months were highly significant compared to standard care at both ≥ 10-point and ≥ 20-point reduction in ODI.

VAS Responder Rates – Baseline to 3 months

In the Intracept arm, responder rates at 3 months were highly significant compared to standard care at both ≥ 1.5 cm and ≥ 2.0 cm decrease in VAS.


Safety Results

There were no device related adverse events. All procedure related adverse events were considered mild and resolved with oral medications.

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Conclusion

The Intracept Procedure led to significant improvement of pain and function in patients with chronic vertebrogenic low back pain.