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, Justiz R, et al. Randomized Controlled Clinical Trial to Study the Effects of Differential Target Multiplexed™ SCS (DTMTM SCS) in Treating Intractable Chronic Low Back Pain: Long-term Follow-Up Results. Presented at: North American Neuromodulation Society 24th Annual Meeting. Jan 15-16, 2021. Virtual.