Transcript 5-6-5 - North American Neuromodulation Society

The Use of Tripolar leads in Spinal
Cord Stimulation for the Treatment
of Axial Back Pain for FBSS
Does it work?
• H Al-Jehani and L Jacques
• Montreal Neurological Institute and Hospital
• McGill University, Montreal Canada
Disclosures
• Independent study with no industry
sponsorship
Mt. Merou
View From Kilimanjaro 2003
Definition
Failed Back Surgery Syndrome (FBSS)
– presents with chronic pain that has
not responded to one or more
spinal surgeries intended to correct
the cause of pain
– pain remains chronic and intractable
Process: Study Design
• Randomized controlled trial (RCT) on the
effectiveness and cost efficacy of SCS vs.
conventional medical management
(CMM) in patients with FBSS
• 100 patients with chronic neuropathic
pain predominantly in the leg(s)
following at least one spinal surgery,
randomized 1:1
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Summary at 24 Months
Significant difference from baseline achieved in
the SCS-continue group in main outcomes:
– Leg pain relief (p<0.0001)
– Quality of life (SF-36 and EQ-5D, p<0.01)
– Disability (ODI, p=0.0002)
Sustained effect of SCS over 24 months
Secondary Outcomes in SCS-continue Group
Significant reduction in leg pain VAS over 24 months
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Secondary Outcomes in SCS-continue Group
Statistically significant reduction in back pain VAS over 24 months
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Old vs. New Implantable Technologies
• PROCESS: percutaneous and surgical
leads 1X4 or 2X4 (1 or 2 programs)
•Tripolar leads with groups of up to 4
programs and 16 contact points (5-6-5)
Where to Stimulate to Optimize Back Coverage
CSF Width Depends on Level
Fierabend HK, et al., Brain, vol 125, 2002.
Cathode Locations For Optimal Back
Pain Coverage
Ultimate Target T8/T9
Without Dorsal Root Stimulation
Tripolar Stimulation With Anodes
Shielding the Roots
Prager JP & Chang JH, INS meeting, July 2000
Our Series
• 105 patients
• June 2007-2010
• Diagnosis
• FBSS (71)
• CRPS (19)
• Others (15) Complex Pain
FBSS 2007-2010
• 40 of 71 patients participated
(geographical)
• 25 M:15 F
• 52 yrs on average (39-64)
• 51% were 3rd party payers
• Average follow up: 16 mths (2-42)
FBSS Patient’s Epidemiology
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45% pts with spinal fusion
1.6 spinal lumbar segments (1 to 4)
1.8 surgeries (1 to 6 surgeries)
Time since 1st back surgery
-Avg: 11 years
-Range 2-36 years
FBSS – Back Pain Component
• 65% reported >50% overall back pain
- 70-100% (20%)
- 50-69% (45%)
- <50 % (35%)
FBSS – Response Rate
• 65% reported more than 50%
decrease in back pain with VAS score
- >70%
(45%)
- 50-69%
(20%)
- Suboptimal (10%)
- 40% of pts became narcotic free
starting at 10-12 mths
Pain Reduction and Narcotic use
Initial Observational Review
Multi-Centre Experience
France, Montreal & Regina
• ~ 100 patients with FBSS
• Dr. Rigoard, Dr. Delmotte,
Dr. Kumar, Dr. Jacques,
Dr. Aljehani
• Looked at high back, low back
and leg coverage with 47
programming options
Anatomical Coverage – Our Center
• High back coverage 24 pts (60%),
• Average configurations 6/pt (range 1-24)
• Low back coverage 36 pts (90%),
• Average configurations 10/pt (range 1-33)
• Added programs 29 pts (72.5%)
% of Pts That Obtain Paresthesia On All Configurations Tested
HB - 1 Side
LB – 1 Side
HB – 2 Sides
LB – 2 Sides HB/LB – 2 Sides
1 – Leg
2 - Legs
Examples of Tested Lead Configurations
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Transverse
Transverse
Longitudinal
Circular
Semi Circular
Full Lead
Best Outcome Configurations Tested
Transverse Tripolar vs. Longitudinal Tripolar
•Orange = Transverse Tripolar
•Blue = Longitudinal Tripolar
HB - 1 Side
LB – 1 Side
HB – 2 Sides
LB – 2 Sides
HB/LB – 2 Sides
1 – Leg
2 - Legs
Discussion
• Leg pain still tends to be easier to treat than
high/low back pain
• Maximizing paresthesia is necessary to
achieve successful outcomes
• 5-6-5 lead can use up to 16 electrical contacts,
with millions combinations
Discussion – Con’t
• This allows for anatomical asymmetry and
provides more options for better paresthesia
coverage of painful areas.
• Computerized models have demonstrated that
transverse Tripolar stimulation may be
effective for the relief of low back pain for
patients with FBSS
Struijk JJ, Holsheimer J. Transverse tripolar spinal cord stimulation: Theoretical performance of a dual channel system. Med
Biol Eng Comput 1996;34: 273-279
Oakley et al, Transverse Tripolar Spinal Cord Stimulation: Results of and International Multicenter Study, Neuromodulation
Volume 9, Number 3 2006 192-203
Conclusions
• Tripolar lead configuration is a promising tool
for powerful specific targeting of axial low
back pain
• This multicenter study will help us better
understand the benefits of different
configurations to achieve maximum back pain
coverage in a timely fashion and provide long
term outcome measures