CLINICAL OUTCOMES: DTM™ SCS 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% was the highest back pain responder rate reported at 12 months in similar RTCs for a greater-than 50% improvement
*

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%, or 7 out of 10, patients treated with DTM SCS therapy were profound back pain responders compared to those treated with conventional SCS treatment

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 VAS scores at 12 months were 42 for DTM SCS patients and 37 for conventional SCS patients

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

1

Fishman M, Cordner H, Justiz R, et al. 12-month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. Pain Pract. 2021. doi: 10.1111/papr.13066.