6/20/2018 1 Evidence for Headache Procedures Matthew S Robbins, MD Associate Professor of Neurology, Albert Einstein College of Medicine Chief of Neurology, Jack D Weiler Hospital, Montefiore Medical Center Director of Inpatient Services, Montefiore Headache Center Disclosures • Contracted research: eNeura (site PI for study; funds to institution) Off-label uses • Local anesthetics generically approved for nerve blocks, infiltration • Steroids generically approved for intramuscular, intra-articular, soft tissue, or intra-lesional injection Objectives 1. To evaluate the level of evidence for onabotulinumtoxinA, peripheral nerve blocks, trigger point injections, and sphenopalatine ganglion blocks 2. To appraise safety concerns and precautions with clinic-based headache procedures 3. To examine the role of steroids in nerve blocks for migraine and cluster headache
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6/20/2018
1
Evidence for Headache Procedures
Matthew S Robbins, MD
Associate Professor of Neurology, Albert Einstein College of MedicineChief of Neurology, Jack D Weiler Hospital, Montefiore Medical Center
Director of Inpatient Services, Montefiore Headache Center
Disclosures• Contracted research: eNeura (site PI for study; funds to institution)
Off-label uses
• Local anesthetics generically approved for nerve blocks, infiltration
• Steroids generically approved for intramuscular, intra-articular, soft
tissue, or intra-lesional injection
Objectives
1. To evaluate the level of evidence for onabotulinumtoxinA, peripheral
nerve blocks, trigger point injections, and sphenopalatine ganglion
blocks
2. To appraise safety concerns and precautions with clinic-based
headache procedures
3. To examine the role of steroids in nerve blocks for migraine and
cluster headache
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Evidence for headache procedures
1. OnabotulinumtoxinA
2. Peripheral nerve blocks
3. Trigger point injections
4. Sphenopalatine ganglion blocks
5. Training
6. Summary
OnabotulinumtoxinA for chronic migraine
Dodick DW et al, Headache 2010
Blumenfeld AM et al, J Headache Pain 2018
Blumenfeld A et al, Headache 2008
Mathew NT et al, Headache 2009
versus other agents: similar efficacy, better tolerated
PREEMPT Phase 3 pooled COMPEL (long-term)
Safety in chronic migraine
• Neck pain 4-8%
• Muscle weakness 5-6%
• Rash* <0.5%
• Caution: patients with NMJ disorders
• One fatal case in use for pain (reconstituted in lidocaine)
Aurora S et al, Cephalalgia 2010Diener HC et al, Cephalalgia 2010Blumenfeld AM et al, J Headache Pain 2018Blumenfeld AM et al, Headache 2017Li M et al, J Forensic Sci 2005
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Response prediction: pain directionality
Jakubowski M et al, Pain 2006 Files JA et al, Headache 2014
Evidence for headache procedures
1. OnabotulinumtoxinA
2. Peripheral nerve blocks
3. Trigger point injections
4. Sphenopalatine ganglion blocks
5. Training
6. Summary
Blumenfeld A et al, Headache 2013
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Double-Blind, Placebo-Controlled RCTs of PNBs for Migraine Prevention
StudyHeadache
DisorderN
TreatmentPrimary Outcome Results
Active Placebo Frequency
Dilli et al
Cephalalgia
2015
Episodic and
chronic migraine63
GON injection (U or
B) with 2.5 ml 0.5%
bupivacaine + 0.5 ml
20 mg
methylprednisolone
GON injection
(U or B) with
2.75 ml saline +
0.25 ml 1%
lidocaine
OnceAfter 4 weeks ≥ 50% ↓ in frequency of moderate or severe HA
days was 30% for both groups but no differences
Palamar D
et al
Pain
Physician
2015
Chronic migraine 32
GON injection (B)
with 1.5 ml 0.5%
bupivacaine
GON injection
(B) with 1.5 ml
saline
Once
(ultrasound
guidance)
After 4 weeks significant ↓ average VAS score
Inan et al
Acta Neurol
Scand
2015
Chronic migraine 72
GON injection (U or
B) with 1.5 ml 0.5%
bupivacaine + 1 ml
saline
GON injection
(U or B) with 2.5
ml saline
Weekly x 4
weeks
After 1 month significant ↓ HA days, VAS score, though not
hours
Cuadrado
et al
Cephalalgia
2017
Chronic migraine 36
GON (B) injection
with
2 ml of 0.5%
bupivacaine
GON (B)
injection with 2
ml saline
Once After 1 week significant ↓ moderate-severe HA days
Gul et al
Acta Neurol
Scand
2017
Chronic migraine 44
GON (B) injection
with 1.5 ml 0.5%
bupivacaine + 1 ml
saline
GON (B)
injection with 2.5
ml saline
Weekly x 4
weeks
Significant headache day reduction at 2 months and 3 months
but not 1 month
Adapted from Robbins MS. Scientific American Neurology; 2016
Systematic reviews
RCT: GON blocks for acute migraine in ED
• Population:
– Acute migraine in ED with moderate-severe headache >1h post-IV metoclopramide
• Treatment:
– Active: B/L GONB with 6cc of 0.5% bupivacaine– Sham: B/L intradermal scalp injection with 1cc of 0.5% bupivacaine
• Outcome:
– Complete headache freedom 30 minutes after injections
• Sig. pain reductions vs placebo at 15m, 30m, 24h post-treatment
• HIT-6 scores significantly decreased from before treatment to the final treatment (P=0.005) vs NSD in the placebo group
• No significant or lasting adverse events (abnormal taste blinding?)
• 2° endpoints: Decreased headache days at 1 month, HIT-6 scores at 1 and 6 months, and medication usage; trends but NSD vs placebo
Emergency department: acute headache (N=87)
• 50% pain reduction: 48.8% bupivacaine vs 41.3% placebo (No SD)
• 24-hour headache-free: 24.7% difference (95% CI 2.6%–43.6%)
• 24-hour nausea free: 16.9% difference (95% CI 0.8% to 32.5%)
Cady R et al, Headache 2015
Cady R et al, Headache 2015
Schaffer JT et al, Ann Emerg Med 2015
Evidence for headache procedures
1. OnabotulinumtoxinA
2. Peripheral nerve blocks
3. Trigger point injections
4. Sphenopalatine ganglion blocks
5. Training
6. Summary
Training
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Evidence for headache procedures
1. OnabotulinumtoxinA
2. Peripheral nerve blocks
3. Trigger point injections
4. Sphenopalatine ganglion blocks
5. Training
6. Summary
Headache procedure evidence summary
Procedure Headache Disorders IndicationInjection Series
Best evidence
OnabotulinumtoxinA
Chronic migraine
Post-traumatic headache
NDPH
Nummular headache
Trigeminal neuralgia
ProphylaxisRepetitive
3 month intervalsChronic migraine
Peripheral nerve blocks /injections
Cluster
Migraine
Hemicrania continua
NDPH
Cervicogenic headache
Post-dural puncture headache
Acute treatment or
short-term prophylaxisSingle or repetitive
Cluster
Chronic migraine
Acute migraine
Trigger point injectionsETTH, CTTH
Migraine
Cervicogenic
Acute treatment or
short-term prophylaxisSingle or repetitive TTH
Sphenopalatineganglion blocks
Chronic migraine
Cluster
Hemicrania continua
Trigeminal neuralgia
Idiopathic facial pain
Acute treatment or
short-term prophylaxisSingle or repetitive Chronic migraine
Ashkenazi A et al, Headache 2013
Blumenfeld A et al, Headache 2013
Robbins MS et al, Headache 2014
Robbins MS et al, Headache 2016
Summary
1. Onabotulinumtoxin A is indicated for chronic migraine, and is effective, safe and with few contraindications.
2. Peripheral nerve injections have the best evidence for cluster headache followed by chronic migraine, but are useful for many headache disorders.
3. Adding a steroid to an occipital nerve block may be particularly effective for cluster headache but is of uncertain benefit for migraine.
4. Trigger point injections may be particularly effective in tension-type headache, are identified by physical examination, and should be restricted to local anesthetics only.
5. Sphenopalatine ganglion blocks are safe and potentially effective, though the evidence is emerging.
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Ongoing studies
NCT Number Title Conditions Interventions Location