EMERGING EVIDENCE — REAL-WORLD OUTCOMES

A Large Retrospective, Multi-Center Cohort Study Evaluating a Novel SCS Workflow for Failed Back Surgery Syndrome (FBSS) Back and Leg Pain: Final Analysis with 3+ Month Outcomes

THERAPY DESCRIPTION

  • ICD 10 indicating post laminectomy or chronic postoperative pain
  • Patients diagnosed with low back and/or leg pain
  • High-dose (HD) stimulation before low-dose (LD) stimulation
  • Pre-defined high-dose stimulation with 1,000 Hz, 90 μs
  • Stimulation delivered with a bi-pole electrode configuration at the T9-T10 interspace
  • Minimum 48 to 72 hours to respond to therapy

CHANGE IN PAIN FROM SCS SCREENING TRIALS (N = 114)

83% of patients
Achieved an average of 75% pain relief during the final screening trial
Chart depicting the change in pain from spinal cord stimulation screening trials (N=114)

CHANGE IN PAIN FOR EACH FOLLOW-UP GROUP

Chart depicting the change in reported pain in spinal cord stimulation trial participants at 1 and 3-month intervals. 85% (33 of 39) of patients who completed a 3+ month follow-up visit had significant and sustained pain relief.

85% (33 of 39) of patients who completed a 3+ month follow-up visit had significant and sustained pain relief.

HIGH DOSE VS. LOW DOSE AT 3+ MONTHS

Chart comparing percentage of patients using high-dose versus low-dose spinal cord stimulation therapy at the 3-month follow-up. 87% (N=39) of patients were using HD at the 3+ months follow-up visit.

87% (N=39) of patients were using HD at the 3+ months follow-up visit.

Verdolin M, Hatheway J, Roy L. A Large Retrospective, Multi-Center Cohort Study Evaluating a Novel SCS Workflow for Failed Back Surgery Syndrome (FBSS) Back and Leg Pain: Final Analysis with 3+ Month Outcomes.
Pain Medicine, Volume 19, Issue 5, 1 May 2018, Pages 1104–1106. Abstract LB004 & Poster from AAPM, April 2018.


Note: This study is one part of the EvolveSM evidence strategy, which includes building a higher level of evidence for the EvolveSM workflow.

ACCESS MANUALS

AND MRI GUIDELINES

From the Medtronic Manual Library by searching for the product name or model number

GO TO THE LIBRARY

ONLINE

LEARNING

Clinicians who have registered for access can view online courses about patient selection and other topics

VIEW COURSE DESCRIPTIONS

PATIENT

EDUCATION

Send your patients to tamethepain.com for information about spinal cord stimulation

GO TO THE WEBSITE
Find a Specialist

For referrals or patients who are moving or traveling

CONTACT US

U.S. Clinician Services
800-707-0933