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Successful Treatment of Low Back Pain with a Novel Neuromodulation Device

Successful Treatment of Low Back Pain with a Novel Neuromodulation Device. Iris Smet, MD 1 Jean-Pierre Van Buyten , MD 1 Adnan Al- Kaisy MB ChB FRCA 2. 1 AZ Nikolaas Hospital, Belgium 2 Guy’s and St. Thomas’ Hospital, United Kingdom. Conflict of Interest.

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Successful Treatment of Low Back Pain with a Novel Neuromodulation Device

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  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

  2. Conflict of Interest • Primary Investigator; study sponsored by Nevro Corporation, Menlo Park, CA

  3. 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

  4. 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

  5. Study Flow (St. Nikolaas Site) Trialed n=42 Failed Trials n=4 • 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) Successful Trials n=38 (90%) Ongoing trial. Interim results shown. 21 patients have passed 6 month visit. Other patients have yet to reach 6 month visit. IPG Implanted 1 Month 3 Months 6 Months

  6. Patient Population Surgical History Patients w/ no prior spine surgery (N=9) FBSS Patients (N=33) 21% • 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. 79% Pain Type Predominant Leg pain patients (N=6) 14% Predominant Back Pain Patients (N=36) 86% 42 Patients Trialed to-date; Mean age is 49 ± 8.1 years, 76% are females

  7. Back and Leg Pain Reduction Average Visual Analog Scale (VAS) for Pain (mean +/- SEM) N=29 N=28 N=21 Back pain VAS: p-value < 0.001 Leg pain VAS: p-value < 0.001 Back pain VAS: p-value < 0.001 Leg pain VAS: p-value < 0.001 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.

  8. No Uncomfortable Stimulation Uncomfortable Stimulation due to Position Change Adjust Stimulation Before or After Position Change • No uncomfortable stimulation with position change • No adjustment of stimulation required with postural change *Kuechmann, 2009 % of Patients % of Patients

  9. Reduction in Opioid Use • Only 14% of patients are using opioids at 6 months N=21 N=21 N=21 N=21 • Only 3 mg of morphine per patient at 6 months

  10. Improvement in Function and Sleep Average Oswestry Disability Index (mean +/- SEM) Number of Sleep Disturbances per Night (mean +/- SEM) Severe disability 9 point reduction was observed in other SCS studies (1) Low disability N=21 N=21 N=29 N=28 N=21 p-value < 0.001 p-value < 0.001 p-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) 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.

  11. 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 Note*: In comparison to baseline

  12. Thank you!

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