Headache Medicine 2021, 12(2):160-167 p-ISSN 2178-7468, e-ISSN 2763-6178

160

ASAA

DOI: 10.48208/HeadacheMed.2021.30

Headache Medicine

Review

Greater occipital nerve block with local anesthetics and

corticosteroids in treatment-resistant chronic migraine

Vlasta Vukovic Cvetkovic

, Roberto De Icco

2,3

, Thien Phu Do

, Lanfranco Pellesi

Messoud Ashina

, Jakob Møller Hansen

1,4

Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Copenhagen, Denmark.

Headache Science Centre, IRCCS Mondino Foundation, Pavia, Italy.

Dept. of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.

Danish Headache Knowledge Center, Rigshospitalet Glostrup, Valdemar Hansens Vej, Copenhagen, Denmark.

Abstract

Objective

We investigated the efcacy and tolerability of greater occipital nerve block with lidocaine

plus betamethasone in adults with chronic migraine in whom two or more previous preventive

treatments were unsuccessful.

Methods

Ten participants were enrolled in a 24-weeks, randomized, double-blind, placebo-controlled,

crossover trial conducted at a single tertiary headache center in Copenhagen (Denmark).

After a 4-week run-in period, participants underwent treatment with bilateral greater occipital

nerve block with lidocaine plus betamethasone (GONb) or lidocaine plus saline (placebo)

with a 4-week interval wash-out phase between the 8-week crossover periods. The primary

aim was to compare the number of migraine days during crossover periods after GONb or

placebo. This trial is registered at ClinicalTrials.gov (NCT02686983).

Results

This study was stopped before achieving the a priori sample size, due to a slow enrollment.

Ten participants were recruited, completed the study and were included in the analyses. At the

baseline, the mean number of monthly migraine days was 22.9 (range, 14-30). No difference

between GONb and placebo on the reduction of monthly migraine days was observed (p =

0.147; 95% CI between 0.6 and 3.7 days). Adverse events were recorded in two patients

after GONb, compared with three patients after placebo.

Conclusions

GONb is not benecial in patients with difcult-to-treat chronic migraine.

Jakob Møller Hansen, MSc,

MD, PhD

Danish Headache Knowledge

Center, Rigshospitalet Glostrup,

Valdemar Hansens Vej, Cope-

nhagen, Denmark.

jakob.moeller.hansen.01@

regionh.dk

Edited by:

Marcelo Moraes Valença

Keywords:

Peripheral nerve block

Headache

Pain

Preventive treatment

Receiced: August 3, 2021

Accepted: September 15, 2021

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Cvetkovic VV, Icco RD, Do TP, Pellesi L, Ashina M, Hansen JM

Greater occipital nerve block with local anesthetics and corticosteroids in treatment-resistant chronic migraine

Introduction

igraine is a prevalent and disabling disorder charac-

terized by moderate to severe, throbbing headache

and associated symptoms, including nausea/vomiting and

hypersensitivity to light and sounds.

1,2

Its chronic form (CM)

is dened by the presence of at least fteen headache days

per month, of which at least eight days with the features of

migraine.

In patients with CM, a preventive treatment is

recommended. Pharmacological therapies such as antide-

pressants, antiepileptics, antihypertensives, botulinum toxin

type A and monoclonal antibodies targeting the calcitonin

gene-related peptide (CGRP) pathway are currently pre-

scribed, but a variable clinical response between patients

makes management challenging.

3,4

Greater occipital nerve block is a peripheral nerve block

technique used for the treatment of headache disorders

with

positive reports in occipital neuralgia, cluster headache,

cervicogenic headache and migraine.

6-8

The mechanism of

action has been suggested to involve peripheral modulation

of the nociceptive transmission in the caudal trigeminal

nucleus and upper cervical segments.

9,10

Greater occipital

nerve block performed with local anesthetics (lidocaine or

bupivacaine) was benecial in several studies for migraine

prophylaxis.

7,11

However, the addition of corticosteroids

is still controversial due to scarce and heterogeneous

studies.

11-14

In this study, we investigated the efcacy and tolerability of

greater occipital nerve block performed with lidocaine plus

betamethasone (GONb) or lidocaine plus saline (placebo)

in patients with CM in whom two or more previous

preventative treatments were unsuccessful.

Methods

The study protocol was reviewed by the Regional Health

Research Ethics Committee of the Capital Region of

Denmark (H-16020715) and the Danish Medicines Agency

(2016-000676-15). Every enrolled patient has given

written informed consent to participate in the study. This

trial is registered at ClinicalTrials.gov (NCT02686983).

Study Participants

Eligible patients were aged 18-75 years, weight <100 kg, with

a history of chronic migraine according to the International

Classication of Headache Disorders

, for at least 6 months

prior to enrollment. Eligible participants also

had previous treatment failure (efcacy, tolerability or both)

with two or more pharmacological classes of the following

migraine preventive medications: tricyclic antidepressants,

antiepileptics, antihypertensives, and botulinum toxin type A.

Individuals were excluded from the study if they have had a

lifetime diagnosis of any other primary headache disorder

according to the International Classication of Headache

Disorders

; were pregnant or nursing; had a history of

psychiatric disorder; had contraindications to corticosteroid

therapy; history of illness of any kind that could preclude

participation in the study according to the investigating

physician; used a preventive migraine medication, device or

procedure within ve half-lives before the baseline phase or

during the baseline phase.

Randomization and Masking

The randomization was designed to ensure an equal

distribution in active-placebo and placebo-active treatment

groups. Each patient was assigned a trial number

corresponding to a hidden treatment order, randomized into

blocks of three people. Each treatment phase included a box

of a masked prefabricated medicine to ensure the double-

blinded design. Thus, the blinded design was ensured by

concealed allocation, and masking of treatment.

Randomization code, medicine and placebo were prepared

by the Central Pharmacy of the Capital Region of Denmark.

At the end of each period, a blinding check was made by

asking if the participant believed they had received active or

placebo treatment.

Study Design and Procedures

The current study was a 24-week, randomized, double-blind,

placebo-controlled crossover trial conducted at a single

tertiary headache center in Copenhagen (Denmark). The

study included a screening visit, a baseline assessment period

(4 weeks) and two double-blind periods (8 weeks each), with

a washout-phase in between (4 weeks) (Figure 1). During

screening, all participants underwent a physical examination

and eligibility assessments. During the baseline assessment

period, participants recorded headache, migraine symptoms

and use of rescue medications.

Randomized participants received treatment on day 1 of the

rst 8-week double-blind period. Before entering the second

double-blind period, participants completed the 4-week

washout-phase and received the second treatment. The

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Cvetkovic VV, Icco RD, Do TP, Pellesi L, Ashina M, Hansen JM

Greater occipital nerve block with local anesthetics and corticosteroids in treatment-resistant chronic migraine

active treatment consisted of bilateral greater occipital nerve

block injections with 0.1 ml of 4% lidocaine plus 7 mg of

betamethasone (GONb), while placebo consisted of bilateral

injections of 0.1 ml of 4% lidocaine plus saline. Patient was

placed in a sitting position, with the head slightly bent to the

side. The injection area was identied 2.0 – 2.5 cm lateral

and 2.0 – 2.5 cm inferior to the protuberantia occipitalis. The

injection site was cleansed with alcohol and the injection was

performed in the most tender area to palpation, with a 23-25

G needle over the identied area, bilaterally.

Figures´ captions

During the double-blind periods, participants recorded daily

data in their headache diary. Moreover, each participant was

contacted by phone four times during the trial: midway through

each treatment period and at the end of each treatment period.

At the end of each treatment period, patients were asked to

rate their satisfaction with the treatment by mean of a 1 (very

dissatised) to 5 (very satised) points Likert scale.

Outcomes

The primary endpoint was comparing the number of monthly

migraine days during periods after active treatment (GONb)

with periods after placebo. A migraine day was dened

as a calendar day with at least four consecutive hours of a

headache fullling the diagnostic criteria for “migraine without

aura” or “probable migraine” according to the International

Classication

, or a headache of any duration successfully

treated with an acute migraine-specic medication.

Secondary endpoints were the change in the number of

headache days per month; change in the number of days

using acute migraine-specic medications per month; change

of headache intensity measured by a numerical rating scale

(NRS) from 0 to 10. Safety was also assessed by observed or

reported adverse events and vital signs assessments.

Statistical Analysis

Sample size was calculated with the following parameters:

mean difference of 5 migraine days between GONb and

placebo; standard deviation of 10% per group; level of

signicance of 5% (two-sided); power of 80%. The suggested

sample size was of 34 patients, 17 of whom allocated to each

treatment group.

Quantitative data are presented as “mean (range)”, and

categorical data as “absolute number (percentage)”. Baseline

characteristics between groups were compared with Mann-

Whitney U test, while comparisons for categorical variables

were performed with Pearson χ

test or Fisher exact test.

Change in primary outcome (monthly migraine days) as well

as in secondary outcomes (monthly headache days, monthly

days of acute migraine medications, and headache intensity)

were analyzed with linear mixed models using the above

described outcomes as dependent variable. As xed-effect

factors we assumed: factor “treatment” (2 levels: GONb vs.

placebo), and factor “period” (2 levels: rst double-blind

period vs. second double-blind period). Patient ID was used

as random-effect factor. Comparisons of adverse events and

blinding check were performed with McNemar´s test. Patients

satisfaction was evaluated with Mann-Whitney U test. The

level of signicance was set at α = 0.050 for all tests. The

Statistical Package for the Social Sciences (SPSS), version 21.0

for Windows, was used for all the computations.

Results

Baseline Characteristics of the Study Population

Figure 1. Flow-chart of the study procedures. GONb: greater occipital nerve block with lidocaine plus betamethasone. Placebo: greater

occipital nerve block with lidocaine plus saline. Group 1 included patients randomized to GONb as rst treatment. Group 2 included patients

randomized to placebo as rst treatment.

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Cvetkovic VV, Icco RD, Do TP, Pellesi L, Ashina M, Hansen JM

Greater occipital nerve block with local anesthetics and corticosteroids in treatment-resistant chronic migraine

Between April 2017 and August 2019, 80 patients were

screened for eligibility and ten were enrolled in the study

(Figure 1). This study was stopped before achieving the a

priori sample size, due to a slow enrollment. Ten patients were

included; ve were randomly assigned to active-placebo group

(Group 1) and ve to placebo-active group (Group 2). Both

groups were balanced in terms of baseline demographic and

disease characteristics (Table 1). We did not nd a carry-over

effect for all primary and secondary outcomes, no interaction

between xed-effect factors occurred. Moreover, the period

effect was not different for all outcomes (Table 2).

Table 1. Clinical and demographic features of the study population

Study population Group 1 Group 2

10 5 5

Age

38.7 (20-57) 46.2 (36-57)

31.2 (17.0-

45.4)

Female sex

8 (80.0%) 4 (80.0%) 4 (80.0%)

Height (cm)

174.1 (164-186)

175.6 (165-

183)

172.6 (164-

186)

Weight (Kg)

78.6 (61-95) 81.2 (61-95) 76.0 (65-90)

Systolic blood pressure (mmHg)

126.5 (105-161)

133.0 (106-

161)

120.0 (105-

133)

Diastolic blood pressure (mmHg)

83.6 (67-94) 88.0 (78-94) 79.2 (67-87)

Heart rate (bpm)

76.7 (66-97) 75.6 (69-84) 77.8 (66-97)

Migraine days per month

22.9 (14-30) 21.2 (14-28) 24.6 (15-30)

Headache days per month

26.4 (16-30) 25.6 (16-30) 27.2 (16-30)

Days of acute drug intake per month

7.1 (0-12) 8.6 (6-11) 5.6 (0-12)

Doses of acute drugs per month

9.9 (0-26) 11.4 (6-15) 8.4 (0-26)

Headache intensity (NRS)

5.9 (3.7-8.1) 5.4 (3.9-7.2) 6.5 (3.7-8.1)

Medication overuse

3 (30.0%) 1 (20.0%) 2 (40.0%)

P r e v i o u s

preventive

treatment

failures

NSAID

1 (10.0%) 0 (0.0%) 1 (20.0%)

Triptan

5 (50.0%) 4 (80.0%) 1 (20.0%)

Opioid

1 (10.0%) 0 (0.0%) 1 (20.0%)

Multiple

3 (30.0%) 1 (20.0%) 2 (40.0%)

1 (10.0%) 1 (20.0%) 0 (0.0%)

≥ 4

8 (80.0%) 3 (60.0%) 5 (100.0%

NRS: numerical rating scale. NSAID: nonsteroidal anti-inammatory drug.

GONb: greater occipital nerve block with lidocaine plus betamethasone.

Placebo: greater occipital nerve block with lidocaine plus saline. Group 1

included patients randomized to GONb as rst treatment. Group 2 included

patients randomized to placebo as rst treatment. Data are presented as “mean

(range)”, or “absolute number (percentage)”

Migraine and Headache Days

Patients from the Group 1 reported a mean of 23.1 (16.0-

29.5) monthly migraine days after GONb, and a mean of

22.0 (16.0-29.5) monthly migraine days after placebo.

Patients from the Group 2 reported a mean of 24.8 (15.0-

30.0) monthly migraine days after GONb, and a mean of

22.8 (11.0-30.0) monthly migraine days after placebo. There

was no difference between GONb compared to placebo

(factor “treatment”:

= 0.147, effect size GONb vs. placebo:

1.5 days, 95% CI between -0.6 and 3.7 days) (Table 2

and Figure 2). Patients from the Group 1 reported a mean

of 26.0 (16.0-30.0) monthly headache days after GONb,

and a mean of 24.2 (16.0-29.5) monthly headache days

after placebo. Patients from the Group 2 displayed a mean of

25.4 (15.0-30.0) monthly headache days after GONb, and

a mean of 25.5 (13.0-30.0) monthly headache days after

placebo. There was no difference between GONb compared

to placebo (factor “treatment”:

= 0.164, effect size GONb

vs. placebo: 0.8 days, 95% CI between -0.4 and 2.1 days)

(Table 2 and Figure 3).

Acute Migraine-Specific Medications

Patients from the Group 1 reported a mean of 9.7 (9.0-10.5)

days of acute migraine-specic medications during GONb,

and a mean of 9.0 (7.0-11.5) days during placebo. Patients

from the Group 2 displayed a mean of 6.3 (0.0-12.5) days

of acute migraine-specic medications during GONb, and

a mean of 4.5 (0.0-10.0) days during placebo. There was

no difference between GONb compared to placebo (factor

“treatment”: p = 0.076, effect size GONb vs. placebo: 1.3

medications, 95% CI between -0.1 and 2.6 medications)

(Table 2 and Figure 2).

Headache Intensity

Patients in the Group 1 reported a mean NRS of 5.6 (range:

4.9-7.2) after GONb, and a mean NRS of 5.7 (range: 4.9-

7.7) after placebo. Patients in the Group 2 reported a mean

NRS of 7.1 (range: 4.4-8.9) after the GONb, and a mean

NRS of 6.8 (range: 4.5-7.9) after placebo. There was no

difference between GONb compared to placebo (factor

“treatment”: p = 0.503, effect size GONb vs. placebo: 0.1,

95% CI between -0.2 and 0.4) (Table 2 and Figure 2).

Blinding Check and Patient Satisfaction

Four out of 10 patients (40%) after GONb, and 2 out of 10

patients (20%) after placebo declared they received active

treatment (p = 0.628). The average score for the satisfaction

scale was 2.6 (1-4) after GONb, and 2.2 (1-4) after placebo

(p = 0.481).

Safety

All patients from both groups completed the study. Overall, the

procedure was well tolerated either with GONb or placebo.

Two patients reported at least one adverse event (AE) after

GONb, while three patients reported at least one AE after

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Greater occipital nerve block with local anesthetics and corticosteroids in treatment-resistant chronic migraine

Table 2. Clinical ndings during the cross-over trial

Baseline

First period Second period

Month 1 Month 2 Average Month 1 Month 2 Average

Monthly Migraine Days

Group 1 21.2 (14-28) 23.4 (15-30) 22.8 (17-29) 23.1 (16.0-29.5) 23.4 (16-30) 20.4 (16-29) 22.0 (16.0-29.5)

Group 2 24.6 (15-30) 21.4 (11-30) 24.2 (10-30) 22.8 (11.0-30.0) 23.8 (16-30) 25.8 (14-30) 24.8 (15.0-30.0)

Monthly Headache Days

Group 1 25.6 (16-30) 26.2 (15-30) 25.8 (17-30) 26.0 (16.0-30.0) 24.6 (16-30) 23.8 (16-29) 24.2 (16.0-29.5)

Group 2 27.2 (16-30) 25.0 (13-30) 26.0 (13-30) 25.5 (13.0-30.0) 24.6 (16-30) 26.2 (14-30) 25.4 (15.0-30.0)

Acute Migraine-Specific Medications

Group 1 8.6 (6-11) 10.6 (9-14) 8.8 (5-11) 9.7 (9.0-10.5) 9.2 (8-10) 8.8 (0-14) 9.0 (7.0-11.5)

Group 2 5.6 (0-12) 4.0 (0-9) 5.0 (0-11) 4.5 (0.0-10.0) 6.2 (0-11) 6.4 (5-13) 6.3 (0.0-12.5)

Headache intensity

Group 1 5.4 (3.9-7.2) 5.9 (5.1-7.5) 5.4 (3.8-7.0) 5.6 (4.9-7.2) 5.8 (4.9-8.1) 5.6 (4.9-7.2) 5.7 (4.9-7.7)

Group 2 6.5 (3.7-8.1) 6.7 (4.1-7.9) 6.8 (4.8-8.0) 6.8 (4.5-7.9) 6.9 (4.2-9.0) 7.1 (4.5-8.8) 7.1 (4.4-8.9)

Headache intensity was measured with a numerical rating scale (NRS) from 0 to 10. Group 1 included patients randomized to GONb as

rst treatment. Group 2 included patients randomized to placebo as rst treatment. GONb: greater occipital nerve block with lidocaine plus

betamethasone. Placebo: greater occipital nerve block with lidocaine plus saline. Grey shades: periods after active treatment. Data are presented

as “mean (range)”.

Figure 2. Change in migraine days per month. Panel on the left describes changes in Group 1. Panel on the right describes changes in Group 2. Grey lines:

estimates of individual patients. Red lines: mean values. Continuous lines: study period after GONb. Dashed lines: study period after placebo. M1: rst month

of the period; M2: second month of the period. GONb: greater occipital nerve block with lidocaine plus betamethasone. Placebo: greater occipital nerve block

with lidocaine plus saline.

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Greater occipital nerve block with local anesthetics and corticosteroids in treatment-resistant chronic migraine

placebo (

= 1.000). Eight AEs were reported in total, all of

them being transitory, treatment-related and mild in intensity.

Five AEs were reported after GONb, and three after placebo.

The most frequent AE was muscle tension at the neck level.

Discussion

The main nding of this cross-over study is that GONb with

corticosteroids was not benecial in CM-patients with several

prior treatment failures. To our knowledge, this is the rst

cross-over trial investigating the preventive effect of GONb

technique with lidocaine plus betamethasone in patients with

CM, with a history of multiple unsuccessful pharmacological

treatments. There was not clinically meaningful or statistical

difference between GONb and placebo for either primary

or secondary efcacy endpoints, including migraine days,

headache days, acute medication days, and headache

intensity. Adverse events reported after GONb were not

different to those reported after placebo.

GONb with corticosteroids may be considered a further

therapeutic opportunity for chronic headaches refractory to

conventional preventive therapies.

14,15

A recent meta-analysis

reported a clinical benet of greater occipital nerve block

with local anesthetics for the preventive treatment of chronic

migraine.

However, the results of the meta-analysis are

Figure 3. Changes of secondary outcomes. Panels on the left describe changes in Group 1. Panels on the right describe changes in Group

2. Grey lines: estimates of individual patients. Red lines: mean values. Continuous lines: study period after GONb. Dashed lines: study

period after placebo. M1: rst month of the period; M2: second month of the period. NRS: numerical rating scale. GONb: greater occipital

nerve block with lidocaine plus betamethasone. Placebo: greater occipital nerve block with lidocaine plus saline.

166

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Cvetkovic VV, Icco RD, Do TP, Pellesi L, Ashina M, Hansen JM

Greater occipital nerve block with local anesthetics and corticosteroids in treatment-resistant chronic migraine

affected by several methodological limitations, including

pooling together different study designs. In our study, the

population was comprised of patients with CM with at least two

previous unsuccessful pharmacological preventive treatments,

who are typically excluded in randomized clinical trials. The

current ndings are consistent with trials with comparable

study designs. Two studies reported no difference between

patients who received local anesthetics plus triamcinolone

compared to patients who received only anesthetics.

12,14

Also,

one study found no diversity between GONb performed with

bupivacaine plus methylprednisolone or lidocaine alone.

Strengths and Limitations

The strength of this study includes the enrollment of a deeply

characterized cohort of patients with difcult-to-treat CM and

use of clinical outcomes as recommended by the International

Headache Society.

Furthermore, the cross-over design

reduced variability, as patients represented their own controls.

The use of blinding check revealed no masking issues during

the double-blind treatment phase. The major limitation was

the low number of recruited patients, which was lower than

expected. The primary reason was that ongoing competitive

clinical trials with the new anti-CGRP monoclonal antibodies

were offered to the same patient population. At the same time,

the recorded effect size for the primary outcome (GONb vs.

placebo: 1.5 days, 95% CI between -0.6 and 3.7 days),

was far from the clinically meaningful difference we assumed

for the sample size calculation. The small sample may have

limited statistical detection of signicant changes in endpoints,

but we emphasize that no clinical benet in individual patients

was observed. This is also reinforced by the low grade of

satisfaction expressed by patients after both GONb and

placebo. Regardless, our results should be interpreted with

caution.

Conclusion

This study expands data about the effective use of greater

occipital nerve block in the prevention of CM. Greater occipital

nerve block with lidocaine and betamethasone has no benet

in patients with CM, with a history of two or more previous

unsuccessful pharmacological preventive treatments.

Conflicts of Interest: VVC, RDI, TPD and LP declare no

competing interests. JMH reports personal fees from Eli Lilly,

Novartis and Teva. MA reports personal fees from Alder,

Allergan, Amgen, Eli Lilly, Lundbeck, Novartis and Teva. MA

participated in clinical trials as the principal investigator for

Alder, Amgen, ElectroCore, Eli Lilly, Novartis and Teva trials.

MA reports receiving consulting fees and advisory boards fees

from Alder, Allergan, Amgen, Eli Lilly, Lundbeck, Novartis, and

Teva, fees for serving as a principal investigator, paid to his

institution, from Alder, Allergan, Amgen, Electro-Core, Eli Lilly,

Lundbeck, Novartis, and Teva, and grant support, paid to

his institution, from Novo Nordisk Foundation, Novartis, and

Lundbeck Foundation.

Author Contributions: VVC: contributed to study conception

and design; contributed to data acquisition and interpretation;

critically revised the manuscript before nal approval.

RDI: performed statistical analysis; contributed to data

interpretation; contributed to rst draft of the manuscript;

critically revised the manuscript before nal approval.

TPD: contributed to data acquisition and interpretation;

contributed to rst draft of the manuscript; critically revised the

manuscript before nal approval.

LP: contributed to data interpretation; contributed to rst draft

of the manuscript; critically revised the manuscript before nal

approval.

MA: contributed to study conception and design; contributed

to data interpretation; critically revised the manuscript before

nal approval.

JMH: contributed to study conception and design; contributed

to data acquisition and interpretation; critically revised the

manuscript before nal approval.

All authors read and approved the nal manuscript.

Vlasta Vukovic Cvetkovic

https://orcid.org/0000-0003-4963-4541

Roberto De Icco

https://orcid.org/0000-0001-9415-4948

Thien Phu Do

https://orcid.org/0000-0002-9631-0665

Lanfranco Pellesi

https://orcid.org/0000-0003-4137-5039

Messoud Ashina

https://orcid.org/0000-0003-0951-5804

Jakob Møller Hansen

https://orcid.org/0000-0002-9417-2481

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