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 PhysicianMBBS FAFMM GDMM(Hons) MPainMed FIPP

Disclosure StatementNo 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

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.

Supraorbital Trial

Supraorbital Leads

Right Supraorbital and right vertical occipital leads

Occipital and Supraorbital Leads – Unilateral Chronic Daily headache

Supraorbital

Occipital

Occipital Stimulation - Migraines

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

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)

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%

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

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)

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 Implant Post Implant

Nec

k D

isab

ilit

y In

dex

(%

)

62.156.7

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 Implant Post Implant

Zu

ng

De

pre

ss

ion

SD

S I

nd

ex

(%

)

55.1

47.0

PNFS for occipital/craniofacial pain: Sustained Pain Relief

Pain relief achieved initially following implantation was

sustained at follow up intervals of ≥12 months.

PNFS for occipital/craniofacial pain: Complications

Two thirds of patients achieved favorable outcomes following reposition and/or re-implantation

Complication No. of Patients

Outcome

Reposition / Re-implant / Replace

Explanted

Hardware Erosion 9 6 3

Lead Infection 2 1 1

Hardware Migration 1 1 -

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