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

• Primary Investigator; study sponsored by Nevro Corporation, Menlo Park, CA

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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

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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

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Study Flow (St. Nikolaas Site)

• 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)

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IPG Implanted

1 Month

3 Months

6 Months

Successful Trialsn=38 (90%)

Trialedn=42

Failed Trials n=4

Ongoing trial. Interim results

shown.

21 patients have passed 6 month

visit.

Other patients have yet to reach

6 month visit.

Patient Population

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

Patients w/ no prior spine surgery (N=9) FBSS Patients(N=33)

Predominant Back Pain Patients (N=36)

Predominant Leg pain patients(N=6)

21%

79%

14%

86%

Pain Type

Surgical History

• 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.

Back and Leg Pain Reduction

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N=29 N=28 N=21

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.

Average Visual Analog Scale (VAS) for Pain(mean +/- SEM)

Back pain VAS: p-value < 0.001Leg pain VAS: p-value < 0.001

Back pain VAS: p-value < 0.001Leg pain VAS: p-value < 0.001

No Uncomfortable Stimulation

• No uncomfortable stimulation with position change

• No adjustment of stimulation required with postural change

*Kuechmann, 2009

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Uncomfortable Stimulation due to Position Change

% o

f P

atie

nts

Adjust Stimulation Before or After Position Change

% o

f P

atie

nts

Reduction in Opioid Use

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N=21 N=21

• Only 14% of patients are using opioids at 6 months

N=21 N=21

• Only 3 mg of morphine per patient at 6 months

Improvement in Function and Sleep

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

Average Oswestry Disability Index(mean +/- SEM)

Lowdisability

Severe disability

N=29

p-value < 0.001p-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)

N=28 N=21

Number of Sleep Disturbances per Night

(mean +/- SEM)

N=21N=21

p-value < 0.001

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

• 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

11Note*: In comparison to baseline

Thank you!

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