PowerPoint Presentation...2015 Episodic and chronic migraine 63 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
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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
6/20/2018
2
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
6/20/2018
3
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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4
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
• Enrollment:
– 32 month period
– 76 patients screened
– 28 patients enrolled
• 15 received sham injection• 13 received GONB
Friedman BW et al, AHS 2018 LBOR-07
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5
RCT: GON blocks for acute migraine in ED
Friedman BW et al, AHS 2018 LBOR-07
Outcome variableSham Injection
(n=15)
GON Block
(n=13)Difference (95%CI) p value
Headache freedom 30m 0 (0%) 4 (31%) 31% (6, 56%) 0.02
Sustained headache relief 0 (0%) 3 (23%) 23% (0, 46%) 0.09
Would want same injection
again
Yes 3 (20%) 5 (38%) 18% (-15, 52%) 0.31
No 6 (40%) 6 (46%)
Not sure 6 (40%) 2 (15%)
Headache intensity 60m
Severe 4 (27%) 2 (15%) 36% (1, 71%) 0.06
Moderate 6 (40%) 2 (15%)
Mild 5 (33%) 5 (38%)
None 0 (0%) 4 (31%)
Injection site pain (n=2, GONB)Neck pain (n=2, 1 GONB, 1 sham)Dizziness (n=1, sham)
Shingles (n=1, GONB)
Guessed correct treatmentActive: 62%Sham: 67%
RCT: GON blocks vs sham vs IV therapies
Korucu O et al, Acta Neurol Scand 2018
• N=60
• IV group
• Not blinded
• Dexketoprofen +
metoclopramide
• No side effects
Nerve blocks with steroids
• Migraine: no benefit versus anesthetic alone
• Cluster: should be used in GON injections
– 2 RCTs; Level A evidence
• Adverse effects
– Systemic if repetitive
– Local if dose high
Blumenfeld A et al, Headache 2013
Ashkenazi A et al, JNNP 2008
Kashipazha D et al, Glob J Health Sci 2014
Ambrosini A et al, Pain 2005
Shields KG et al, Neurology 2004
6/20/2018
6
Adding steroids to anesthetics for migraine
Ashkenazi A et al, J Neurol Neurosurg Psychiatry 2008
Kashipazha D et al, Glob J Health Sci 2014
Mean headache severity
before and 20m post-GONB + TPI
Variable Group A Group B P-value
Headache-
free days2.7±3.8 1.0±1.1 0.67
Headache
response days
14.3±15.1 5.5±4.9 0.60
Intervention (n=24)
B/L GON injectionsLidocaine + triamcinolone
Control (n=24)
B/L GON injections
Lidocaine + saline
GON injections have evidence for cluster
Reference Disorder N Active Placebo Primary outcome
Ambrosini A et al
Episodic and
chronic cluster
headache
16
2.5 ml suboccipital injection of
betamethasone dipropionate
12.46 mg + betamethasone
disodium phosphate 5.26 mg
+ 0.5 ml xylocaine 2%
2.5 ml suboccipital injection of 2 ml
saline
+ 0.5 ml xylocaine 2%
Active: 85% attack-free
in the 1st week vs 0% in
the placebo group
(p=0.0001)
Leroux E et al
Episodic and
chronic cluster
headache
43
3 unilateral suboccipital injections
(48-72 hours apart) of 1.5 ml
cortivazol 3.75 mg
3 suboccipital injections (48–72
hours apart) of 1.5 ml saline
Active: 95% ≤2
attacks/day versus 54%
controls
OR 14.5
(1.8-116.9; p=0.012)
2-4 days after 3rd
injection
Ambrosini et al. Pain. 2005
Leroux E et al. Lancet Neurol 2011
GON injection for cluster headache
• GON steroid injection is the only cluster headache
prophylactic therapy with 2 Class I studies and a Level A
recommendation
Robbins MS et al. Headache 2016
6/20/2018
7
GON injection versus oral steroid for cluster
• 43 patients received transitional therapy over a total of 151 encounters
• 16 patients received both
Wei J, Robbins MS, Headache 2018
Response Level
Oral steroid encounters n=81 (% total)
GON injection encountersn=59 (% total)
Complete * 41(50.6%) 21 (35.6%)
Partial ** 26 (32.1%) 17 (28.8%)
None 7 (8.6%) 11 (18.6%)
Unclear 7 (8.6%) 10 (16.9%)
Response to oral but
not injection
38%
Response to injection but not oral
6%
Response to both50%
Response to neither
6%
Other patient populations
Pediatrics
Pregnant women
Older adults
Evidence for headache procedures
1. OnabotulinumtoxinA
2. Peripheral nerve blocks
3. Trigger point injections
4. Sphenopalatine ganglion blocks
5. Training
6. Summary
6/20/2018
8
Trigger point injections: evidence
Robbins MS 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
Sphenopalatine ganglion blocks
http://tianmedical.com/europe/images/spgb_oldtechnique1.png
Maizels M et al. JAMA 1996
Robbins MS et al. Headache 2016
6/20/2018
9
SPG Blockade: RCTs
Chronic migraine (N=38)
• B/L SPG blocks twice per week for 6 weeks
• 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
6/20/2018
10
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.
6/20/2018
11
Ongoing studies
NCT Number Title Conditions Interventions Location
NCT02665273
GON Block With
Bupivacaine for Acute Migraine in ED
Migraine Procedure: GON block
Procedure: Sham
Montefiore Medical
Center
NCT03159000
A Research Study of GON
Block as a Treatment for Acute Migraine Attacks
Migraine
Drug: Saline
Combination Product: lidocaine/ bupivacaine
Thomas Jefferson
University
NCT03066544
Status Migrainosus -
Differentiating Between Responders and Non-
responders
Migraine
Drug: Bupivacaine
Drug: Naratriptan Pill Drug: Dexamethasone
Drug: Ketorolac
Hartford HealthCare
Thank you
@mrobbinsmd
marobbin@montefiore.org
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