1. Neuromodulation for Headache & Craniofacial Pain: 50 Consecutive Cases Paul Verrills MD, David Vivian MD, Bruce Mitchell MD and Adele Barnard PhD Metro Spinal Clinic, Melbourne Dr Paul Verrills Musculoskeletal Physician MBBS FAFMM GDMM(Hons) MPainMed FIPP

2. Disclosure Statement No funds have been received in support of this study Royalties: NIL Stock Options: NIL Teaching – Consultant (adhoc peer-peer) - St. Jude Medical - Arthrocare - Mundipharma - Medtronic - Boston Scientific Research Grant: NIL Travel Support: NIL

3. Chronic Craniofacial Pain Treatment of chronic neuropathic pain in the region of the head, neck and face presents a challenge for pain specialists. Peripheral nerve field stimulation (PNFS) is evolving as a treatment for neuropathic pain Increase in the number of cases of PNFS for the craniofacial region since the publication of Richard Weiner’s study in 1999.

4. Supraorbital Trial

5. Supraorbital Leads

6. Right Supraorbital and right vertical occipital leads

7. Occipital and Supraorbital Leads – Unilateral Chronic Daily headache Supraorbital Occipital

8. Occipital Stimulation - Migraines

9. PNFS for headache and craniofacial pain: Patient Selection Chronic Daily Headache / Occipital Neuralgia / ‘Migraine’ Neuropathic or combined somatic (nociceptive) & neuropathic pain component. Failure to respond to other conservative treatments Red flags excluded Psychological clearance Successful trial phase (eg. >50% pain relief) Informed consent

10. PNFS for headache and craniofacial pain: Study Design Data collected over 4 years 50 consecutive implant patients Follow up rate of 100% Assessments Questionnaires, along with patients’ histories were used to assess Pain (11-point numerical rating scale) Analgesic use Depression (Zung Depression Index) Disability (Neck Disability Index) Follow up of mean 10.8 ± 6.5 months (range 1-36 months)

11. PNFS for headache and craniofacial pain: Decrease in Pain Average pain reduction of 4.8± 2.4 NRS (p ≤ 0.05) Average pain relief of 62.6 ± 26.4% Pain Relief 88% of patients achieved ≥ 25% 76% of patients achieved ≥ 50% 43% of patients achieved ≥ 75%

12. PNFS for headache and craniofacial pain: High patient satisfaction rate 82% of patients were satisfied with their treatment outcome 61% of patients were either very or completely satisfied

13. PNFS for headache and craniofacial pain: Reduced Analgesic use 77% of patients reported a reduction in analgesic use 66% of patients reported a moderate to extreme decrease Reduction in analgesic use inversely correlated with pain relief (r = 0.75, p ≤0.05) patient satisfaction (r = 0.69, p ≤0.05)

14. PNFS for headache and craniofacial pain: Reduced Disability (NDI) 80% of patients reported reductions in their disability following implantation (p ≤ 0.05) Median NDI reduced by 8.2 ± 8.6% Degree of disability following Implantation 0 20 40 60 80 100 Pre ImplantPost Implant Neck Disability Index (%) 62.1 56.7

15. PNFS for occipital/craniofacial pain: Reduced Depression 70% of patients reported reductions in their depression index following implantation (p ≤ 0.05) Median Zung reduced by 9.2 ± 9.9% Depression following Implantation 0 20 40 60 80 Pre ImplantPost Implant Zung Depression SDS Index (%) 55.1 47.0

16. PNFS for occipital/craniofacial pain: Sustained Pain Relief Pain relief achieved initially following implantation was sustained at follow up intervals of ≥12 months.

17. PNFS for occipital/craniofacial pain: Complications Two thirds of patients achieved favorable outcomes following reposition and/or re-implantation ComplicationNo. of Patients Outcome Reposition / Re-implant / Replace Explanted Hardware Erosion963 Lead Infection211 Hardware Migration11-

18. PNFS for occipital/craniofacial pain: Summary Average pain reduction of 4.9± 2.5 VAS (p ≤ 0.05) Average pain relief of 63.1 ± 27.0%. Reduced disability, analgesic use and depression was observed following PNFS Reduction in analgesic use inversely correlated with pain relief and patient satisfaction This study demonstrates that this reversible, safe and effective treatment is a promising pain relief strategy for an otherwise intractable condition. pverrills@metrospinal.com.au www.metrospinal.com.au