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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.
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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
Sustained effect of SCS over 24 months 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)
Secondary Outcomes in SCS-continue Group Significant reduction in leg pain VAS over 24 months
Secondary Outcomes in SCS-continue Group Statistically significant reduction in back pain VAS over 24 months
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 • 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 ExperienceFrance, 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 + + + + + + -- -- + -- + + + + + + -- + -- + + -- + + + + -- + + + -- + + + 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