Successful Treatment of Low Back Pain with a Novel Neuromodulation Device Iris Smet, MD 1...
-
Upload
christiana-reed -
Category
Documents
-
view
213 -
download
0
Transcript of Successful Treatment of Low Back Pain with a Novel Neuromodulation Device Iris Smet, MD 1...
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
2
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
3
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
4
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)
5
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
6
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
7
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
8
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
9
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
10
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!
12