CLINICAL OUTCOMES: DTM™ RCT SPINAL CORD STIMULATION

LONG-TERM AND SUSTAINED OUTCOMES1

Study objectives

The DTM™ Spinal Cord Stimulation (SCS) RCT is a prospective, post market, multicenter, randomized control trial comparing the efficacy of DTM™ SCS for back pain compared to conventional SCS. Both therapies were evaluated using the Intellis™ neurostimulator.

Primary Objective: The effectiveness of DTM™ SCS in reducing back pain as compared to conventional SCS for the treatment of chronic, intractable back pain measured by the percentage of responders (≥50% reduction in pain) at three months post device activation.

Secondary Objectives evaluated through 12 months:

  • Comparison of the percentage of individual responders between DTM™ SCS and conventional SCS groups in a statistical test of superiority
  • Comparison of back and leg pain relief as measured by VAS
  • Characterization and frequency of treatment related adverse events

Study outcomes1

SUPERIOR BACK PAIN RELIEF WITH DTM™ SCS
84 percent graphic
*

Descriptive comparison including studies with similar design (RCT; randomization >100 subjects; comparing two SCS therapies; with at least 12-Months follow up) and patient populations (inclusion/exclusion criteria; baseline demographics) with back pain responder rates reported. This is not based on a statistical analysis of outcomes between studies.

BACK PAIN RELIEF BY SUBJECT USING DTM™ SCS compared
to CONVENTIONAL SCS AT 12 MONTHS

69 percent back pain relief at 12 months - conventional vs DTM

back pain:  DTM™ SCS COMPARED TO CONVENTIONAL STIMULATION
(BASELINE TO 12 MONTHS FOLLOW-UP)

Back Pain - DTM versus Conventional

Sustained back pain relief with a mean VAS score less than 2 at 12 months.

LEG PAIN: DTM SCS COMPARED TO CONVEnTIONAL STIMULATION
(BASELINE TO 12 MONTHS FOLLOW-UP)

Leg Pain - DTM versus Conventional SCS

Sustained leg pain relief with a mean VAS score less than 2 at 12 months.

1

Fishman M, Cordner H, et al. DTM™ SCS RCT 12-month data results. Presented at a Medtronic webinar, jointly supported by the North American Neuromodulation Society (NANS), World Institute of Pain (WIP), and the American Society for Pain and Neuroscience (ASPN). October 19, 2020. Webinar available on society websites.