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Successful Treatment of Low Back Pain with a Novel Neuromodulation Device. Iris Smet, MD 1 Jean-Pierre Van Buyten , MD 1 Adnan Al- Kaisy MB ChB FRCA 2. 1 AZ Nikolaas Hospital, Belgium 2 Guy’s and St. Thomas’ Hospital, United Kingdom. Conflict of Interest.

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successful treatment of low back pain with a novel neuromodulation device

Successful Treatment of Low Back Pain with a Novel Neuromodulation Device

Iris Smet, MD1

Jean-Pierre Van Buyten, MD1

Adnan Al-Kaisy MB ChB FRCA2

1AZ Nikolaas Hospital, Belgium

2Guy’s and St. Thomas’ Hospital, United Kingdom

conflict of interest
Conflict of Interest
  • Primary Investigator; study sponsored by Nevro Corporation, Menlo Park, CA
key challenges in scs
Key Challenges in SCS
  • Treating back pain remains a challenge
    • Leg pain component only
        • PROCESS Study - Kumar, 2006
  • Uncomfortable stimulation
    • Patients experience “shocking” sensation
    • Stimulation/posture adjustments required to decrease uncomfortable stimulation
        • Kuechmann, 2009
  • Opioids remain part of treatment regimen
    • Side-effects outweigh benefits
        • Van Buyten and Linderoth, 2010
  • Opportunity for SCS in treating back pain
study overview
Study Overview
  • Purpose: Demonstrate effectiveness in chronic back and/or leg pain patients
    • First permanent implant study with this novel SCS
  • Design: Prospective, Observational Study
    • Population: Back pain score > 5 out of 10 on VAS
  • Key Outcomes Measurements
    • Pain relief using Visual Analog Scale (VAS)
    • Functional improvements using Oswestry Disability Index
    • Opioid usage
    • Incidence of SCS-induced movement-dependent discomfort
study flow st nikolaas site
Study Flow (St. Nikolaas Site)

Trialed

n=42

Failed Trials n=4

  • Up to 50 patients will be trialed
    • Study is ongoing (interim results shown)
  • Permanent percutaneous lead trial (Anchored & tunneled)
    • Duration 4 weeks +/- 2 weeks
  • Anatomical not physiological lead placement
  • Adverse Events
    • Infection during trial phase(4), lead migration(2), thrombosis(1), edema(1), pocket pain(2), sensation change(1), skin irritation(2), infection during perm(2)

Successful Trials

n=38 (90%)

Ongoing trial. Interim results shown.

21 patients have passed 6 month visit.

Other patients have yet to reach 6 month visit.

IPG Implanted

1 Month

3 Months

6 Months

patient population
Patient Population

Surgical History

Patients w/ no prior spine surgery (N=9)

FBSS Patients

(N=33)

21%

  • Refractory to conservative treatments (e.g., radiofrequency) with no long-term benefit
  • Considered not to be surgical candidates.
  • Neurosurgeon evaluated for mechanical instability and referred non-surgical candidates to the pain clinic.

79%

Pain Type

Predominant Leg pain patients

(N=6)

14%

Predominant Back Pain Patients (N=36)

86%

42 Patients Trialed to-date; Mean age is 49 ± 8.1 years, 76% are females

back and leg pain reduction
Back and Leg Pain Reduction

Average Visual Analog Scale (VAS) for Pain

(mean +/- SEM)

N=29

N=28

N=21

Back pain VAS: p-value < 0.001

Leg pain VAS: p-value < 0.001

Back pain VAS: p-value < 0.001

Leg pain VAS: p-value < 0.001

Note*: Baseline VAS shown above is from patients who passed 3 month visit. One patient missed 3 month visit, but came for 6 month visit.

no uncomfortable stimulation
No Uncomfortable Stimulation

Uncomfortable Stimulation due to Position Change

Adjust Stimulation Before or After Position Change

  • No uncomfortable stimulation with position change
  • No adjustment of stimulation required with postural change

*Kuechmann, 2009

% of Patients

% of Patients

reduction in opioid use
Reduction in Opioid Use
  • Only 14% of patients are using opioids at 6 months

N=21

N=21

N=21

N=21

  • Only 3 mg of morphine per patient at 6 months
improvement in function and sleep
Improvement in Function and Sleep

Average Oswestry Disability Index

(mean +/- SEM)

Number of Sleep Disturbances per Night

(mean +/- SEM)

Severe disability

9 point reduction was observed in other SCS studies (1)

Low

disability

N=21

N=21

N=29

N=28

N=21

p-value < 0.001

p-value < 0.001

p-value < 0.001

  • Functional Improvement: 21 point reduction at 6 months
  • Sleep Improvement: 87% reduction in sleep disturbances
  • (1) Other SCS study results: 9 point reduction (Taylor, 2005)

Note*: Baseline ODI shown above is from patients who passed 3 month visit. One patient missed 3 month visit, but came for 6 month visit.

summary
Summary
  • Sustained back & leg pain relief at 6 months*
  • Significant elimination and reduction of opioid usage*
  • Improved patient functionality and sleep*
    • No sensation of paresthesia
    • No uncomfortable stimulation
    • Proportion and type of adverse events are consistent with other SCS studies conducted

Note*: In comparison to baseline