CRPS w/ foot

Effects of Spinal Cord Stimulation of theDorsal Root Ganglion (DRG) in the Treatment of Chronic, Intractable Pain:Long-Term Results from Two ProspectiveClinical TrialsL Liem, M.D.FHuygen, M.D., Ph.DMarc Russo, M.D.JPVan Buyten, M.D.I Smet, M.D.Paul Verrills, M.D.Professor Michael Cousins, M.D.Raj Sundaraj, M.D.Charles Brooker, M.D.

NANS 2012CAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.Thank you to the NANS committee for their selection of us to present the long term results of our study to treat pain with spinal cord stimulation of the Dorsal Root Ganglion. I will briefly highlight the long term results from two prospective clinical trials. Research was sponsored by Spinal Modulation.The system is an investigational device and is limited by US law to investigational use only. It is approved for chronic, intractable pain in Europe.1DisclosuresPhilipsBoston ScientificSpinal Modulation

Caution:The Spinal Modulation Axium Spinal Cord Stimulator System is currently an investigational device in the United States and is not approved for use in the United States.CAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.These are the disclosures I have to make2

Specialized delivery system for efficient access to the foramen

Small, flexible leads have been designed specifically for stimulation of the DRG

Small, non-rechargeable neurostimulator designed to complement the lead and system

Conventional LeadDRG Lead

Spinal Cord Stimulation Targeting the Dorsal Root GanglionCAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.There is a specialized delivery system for lead placement Small flexible leads specifically designed for DRG stimulation The power Is delivered by a non-rechargeable battery system, because we need only small amounts of power the battery will last more then 4 years even with all 4 ports used.3Clinical Study Design2 prospective clinical trialsSites in Europe and Australia enrolled subjectsN=32 subjects implanted with Spinal Modulation Axium Spinal Cord Stimulator SystemPrimary and secondary outcome measures capturedTwo (2) on-off periods to demonstrate rebound pain3-30 daysStimulation turned off Trial1 weekScreen FailBaseline4 weeks1 yearBaselineImplantTrial Exit1 weekoffyesno6 months3 months8 weeks*Stimulation turned off Success?CAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.Clinical resultsScreened 48 patientsFailed trial4Study OutcomesPrimaryEfficacy was determined by Visual Analog Scale (VAS)Both overall pain and regional (segmented) VAS scores were collected over time based upon primary, secondary and/or tertiary areas of painSafety was evaluated by collecting adverse events during the course of the trial

SecondaryHealth Related Quality of Life (HR-QoL) EQ-5DProfile of Mood States (POMS)Brief Pain Inventory (BPI)Subject SatisfactionParesthesia Intensity with Changes in Bodily PositionCAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.Primary study outcomes utilized the Visual Analog Scale, we looked at BOTH overall pain and pain in certain regions of the body, like the back, leg, and foot.Secondary outcomes included quality of life, mood, satisfaction, and paresthesia intensity with changes in body position.5Subject DiagnosesDiagnosis#INSFBSS9CRPS8Post-surgical neuropathic pain conditions7Radicular pain8Total Implants32CAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.31 total subjects have been implanted. 30% are FBSS patients and 22% are CRPS. Other neuropathic pain conditions included post-surgical neuralgias (lower limbs, thorax. groin), radicular leg pain without surgery, and post-amputation neuralgia (stump pain).In these studies we excluded the stimulation of the cervical area. Nowadays stimulation of the cervical area is one of the major indication for arm and neuropathic upper limb pain. There is a poster with cervical lead placements.

We are presenting 12 month data.6Primary outcomesVisual Analog Scores (VAS)CAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.What are the primary outcomes?7Primary Outcomes Overall Pain Relief60% reduction at 12 monthsVAS (mm)n=32n=32n=30n=24n=24n=24n=17CAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.SCS of the DRG resulted in a 60% reduction in overall pain at 12 months.

?X% of the patients had >50% pain relief.866% reduction at 12 months* Diagnoses include CRPS, Post-Surgical Pain, FBSS, Radicular PainPrimary Outcomes Leg Pain*VAS (mm)n=25n=25n=24n=19n=22n=19n=13CAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.With leg pain which included CRPS, post-surgical pain, failed back and radicular pain, we saw a 66 % reduction in pain at 12 months.982% reduction at 12 months* Diagnoses include CRPS, Post-Surgical Pain, FBSSPrimary Outcomes Foot Pain*VAS (mm)n=13n=13n=13n=9n=12n=10n=6CAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.For foot pain, which included CRPS, post-surgical pain, and failed back. We saw a 82% in foot pain at 12 months.101 weekNo Stim1 weekNo StimAssessing Rebound Pain after Stimulation is Turned OffCAUTION:The SpinalModulation AxiumSpinal Cord Stimulator System is an investigational device andis limited by United States law to investigationaluse only.During the 12 month study period, there were two moments: at the end of the trial phase, and after 1 month of the permanent implant, that rebound pain was assessed by turning stimulation off for 1 week.In both instances, stimulation off resulted a significant rise of VAS scores.11Less Lead Migration than traditional SCSStimulation leads for SCS of the DRG reported