Acta Neurol Scand 2015: 132: 270–277 DOI: 10.1111/ane.12393

© 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd ACTA NEUROLOGICA SCANDINAVICA

Greater occipital nerve blockade for the treatment of chronic migraine: a randomized, multicenter, double-blind, and placebo-controlled study € G€ Inan LE, Inan N, Karadasß O, ul HL, Erdemoglu AK, T€ urkel Y, Akyol A. Greater occipital nerve blockade for the treatment of chronic migraine: a randomized, multicenter, double-blind, and placebo-controlled study. Acta Neurol Scand 2015: 132: 270–277. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. Objectives – We aimed to assess the efficacy of greater occipital nerve (GON) blockade at chronic migraine (CM) treatment. Materials and methods – Patients with CM were randomly divided into two groups of 42. GON blockade was administered four times (once per week) with saline in group A or bupivacaine in group B. After 4 weeks of treatment, blinding was removed; in group A, GON blockade was achieved using bupivacaine, while group B continued to receive bupivacaine, and blockade was administered once per month, then followed for 2 months. Primary endpoint was the difference in number of headache days, duration of headache, and pain scores. Results – Seventy-two of 84 patients completed the study. After 1 month of treatment, number of headache days had decreased from 16.9  5.7 to 13.2  6.7 in group A (P = 0.035) and from 18.1  5.3 to 8.8  4.8 in group B (P < 0.001), (P = 0.004, between groups); duration of headache (hour) had decreased from 24.2  13.7 to 21.2  13.4 in group A (P = 0.223) and from 25.9  16.3 to 19.3  11.5 in group B (P < 0.001), (P = 0.767, between groups). VAS score decreased from 8.1  0.9 to 6.7  1.6 in group A (P = 0.002) and from 8.4  1.5 to 5.3  2.1 in group B (P < 0.001), (P = 0.004, between groups). After blinding was removed (in 2nd and 3rd month), group A exhibited similar results like group B in 3rd month. Conclusions – Our results suggest that GON blockade with bupivacaine was superior to placebo and was found to be effective, safe, and cost-effective for the treatment of CM. According to our knowledge, this is the first randomized, multicentre, double-blind, and placebo-controlled study in the literature in this field of work.

Introduction

The greater occipital nerve (GON), which derives most of its fibers from the C2 dorsal root, is the primary sensory nerve of the occipital region (1). Local anesthetic alone injected into the GON was used as early as 1940 for headache relief (2). A study of Bovim and another study of Terzi examined the efficacy of lidocaine alone for immediate pain relief and reported that it was significantly 270

€ Karadasß3, L. E. Inan1, N. Inan2, O. 4 H. L. G€ul , A. K. Erdemoglu5, Y. T€urkel5, A. Akyol6 1 Ministery of Health, Neurology Department, Ankara Research and Training Hospital, Ankara, TR; 2 Anesthesiology Algology Department, Gazi University, Ankara, TR; 3Ankara Mevki Military Hospital, Ankara, TR; 4Neurology Department, Fatih University Medical Faculty, Istanbul, TR; 5Neurology Department, Kırıkkale University, Kırıkkale, TR; 6Neurology Department, Adnan Menderes University, Aydın, TR

Key words: migraine; headache; greater occipital nerve block N. Inan, Anesthesiology Algology Department, Gazi University, Ankara, TR Tel.: 00905324149358 Fax: 00903123633396 e-mail: [email protected] Accepted for publication February 23, 2015

more effective for cervicogenic headache than for migraine and tension-type headache (3, 4). Caputi reported that there was variable level of response to bupivacaine injected into both the GON and supraorbital nerves on alternate days (5–10 injections in total) in 11 migraine patients (5). Chronic migraine (CM) is a common neurological disorder, and its treatment can be difficult. Some medications, including anti-epileptics, antidepressants, beta-blockers, and calcium channel

GON blockade in chronic migraine blockers, may be used and cognitive behavioral therapy and botulinum toxin may be effective. Although these treatments may be helpful to some extent, the treatment of CM can still be challenging. GON blockade with local anesthetics has been used for the treatment of such headaches like cluster, cervicogenic, and migraine, but there is a lack of randomized, multicenter, double-blind, and placebo-controlled studies on CM treatment. The aim of this double-blind, placebo-controlled study was to determine the effectiveness of GON blockade with the local anesthetic bupivacaine for the treatment of CM compared to placebo. In this setting, it was also aimed to investigate the further benefits of GON blockade with bupivacaine using the first comparison study with placebo treatment. According to our best knowledge, this is the first randomized, multicentre, double-blind, and placebo-controlled study that shows the efficacy of greater occipital nerve blockade at chronic migraine treatment. Materials and methods

The study protocol was approved by the local ethics committee. This study was registered as a Turkish Ministry of Health drug and pharmacy trial (number 2012-T4137-29-407), and informed consent form was signed by all the patients. This prospective, randomized, multicenter, double-blind, and placebo-controlled study was conducted at six headache and algology centers in five cities. CM was diagnosed according to International Headache Society 2004 Headache Classification Committee Criteria. Patients at each treatment center completed a 4-week headache diary prior to treatment and were then randomly divided into a placebo group: group A (n = 42) and bupivacaine group; group B (n = 42). During 3 months of follow-up, the patients continued to fill out a headache diary. Headache diaries were used to determine the number of headache days, duration of headache, and VAS pain scores (Fig. 1). Exclusion criteria

Patients that had used any kind of prophylactic treatment for headache at the last 30 days, patients that had medication-overuse headache according to The International Classification of Headache Disorders (2nd Edition), patients who received botulinum toxin type A (BoNT-A) therapy, pregnant women, or positive urine

84 randomized patients

42 patients in group A

42 patients in group B

4 weekly injections of placebo GON blockade

4 weekly injections of bupivacaine GON blockade

Blinding is removed

4 weekly injections of bupivacaine GON (37 patients)

1 month of follow-up (40 patients)

1 month of follow-up

Bupivacaine GON blockade and 1 month of follow-up

Bupivacaine GON blockade (35 patients)

Bupivacaine GON blockade (39 patients)

1 month of follow-up

1 month of follow-up

(33 patients completed)

(39 patients completed)

Figure 1. Trial profile.

pregnancy test, patients with known allergies against local anesthetics, patients with a history of malignancy, patients who had a history of cervical or cranial surgery, patients who had received caffeine more than 500 mg/day during last month, patients who had received non-pharmacological therapy for the last 6 months, patients with anemia and bleeding diathesis, patients with major psychiatric disorders (major depression, etc.), patients who used antipsychotic, antidepressant, and anti-epileptic drugs within the previous 3 months, patients with neuromuscular dysfunction, patients using agents that affect neuromuscular functions similar to curare or antibiotics like aminoglycoside, patients with uncontrolled hypertension, patients with hypothyroidism or hyperthyroidism, patients that had a history of primary headaches other than chronic migraine. GON blocking technique

GON blockade was administered 2 cm lateral and 2 cm inferior to the external occipital protuberance in all patients. Each patient sat on a chair near to the examination table and bent their 271

Inan et al. head on their arms, which were placed on the examination table during injection to prevent a probable syncope and trauma. The site of injection was cleansed and disinfected using a local antiseptic solution. All the patients and the physicians were blinded for the given treatment. Patients had no information whether they were getting placebo or active substance, and also the physicians who were applying the procedure were unaware of the substance. On every occasion, injectors were prepared by different person according to the protocol. Blindly prepared solutions of 2.5 ml of saline or 1.5 ml of 0.5% bupivacaine diluted in 1 ml of saline were administered into the disinfected area subcutaneously using a 26G 0.45 3 13-mm needle. Injections were administered just superior to occipital bone. During the procedure, upon reaching the periosteum, the injector was pulled back 1 mm and substance was administered accordingly. Local pressure was applied for 2–3 min to spread the solution and prevent bleeding. All patients that received GON blockade were observed in the department for about an hour following the injection to confirm the absence of any adverse effects. Patients were administered GON blockade (saline or bupivacaine) four times (once per week for 4 weeks), and then blinding was removed. Both patients and physicians had no information about the solutions used until the blinding was opened to minimize possible bias. According to our daily practice, only some patients after GON blockade with 2 ml 0.25% bupivacaine report numbness, some other report hypoesthesia during pinprick tests. To maintain the blindness of patients, a detailed explanation about the side effects of the procedure (local swelling, numbness, or hypoesthesia) were made to every patient before every GON blockade, but the patients were told that these side effects would be unrelated to whether they got the active substance or placebo. Thus, presumptions like ‘numbness after every GON blockade’ and ‘blindness may be affected because of the numbness’ were considered to be solved by this explanation. After GON blockades, physicians did not ask question to the patients whether they knew what they were getting (placebo or drug). Then, patients in group A were administered bupivacaine GON blockade once per week for 4 weeks instead of saline. After 4 weeks, they were followed for 1 month and GON blockade was repeated with the same dose of bupivacaine; a month later, last dose of GON blockade was administered. Patients in group B were followed 272

for 4 weeks, and then GON blockade was repeated with the same dose and, they were followed for the number of headache days, duration of headache, and VAS pain score. Our experience with our patients prior to this study let us to do GON blockade with bupivacaine/saline injections once per week, and subsequently the frequency of injections was changed to once per month. Posterior localization of pain, or the presence of occipital/cervical trigger (or tender) points was not considered as predictive of positive response to GON blockade. Pretreatment mean headache days, duration of headache, and VAS pain scores were compared to post-treatment values in both groups. Mean headache days, duration of headache, and VAS pain scores pre- and post-treatment (placebo and bupivacaine treatments) were compared in group A. In group B, mean headache days, duration of headache, and VAS pain scores for 1 month after the last bupivacaine injection were compared with pretreatment and the second month of bupivacaine treatment values. Statistical analysis

Statistical analysis was performed using SPSS v.21.0 for Windows. Continuous variables are presented as mean  standard deviation (SD) and median (range). Categorical variables are summarized as frequencies and percentages. The chi-square test or Fisher’s exact test was used to determine the associations between categorical variables. Differences in continuous variables between groups were determined via the independent samples t-test. If parametric test assumptions were not satisfied, the Mann–Whitney Utest was used. Within group, differences were verified using Friedman variance analysis. Pairwise comparisons were performed using the Siegel– Castellan test. The level of statistical significance was set at P < 0.05. Results

The study was conducted between December 2012 and December 2013. Figure 1 shows the trial profile. Patient demographic data are shown in Table 1. In total, 84 patients were randomized into groups A and B, each containing 42 patients. In all, 33 patients in group A and 39 in group B completed the study. Pretreatment mean headache duration in group A and in group B was similar. As compared to pretreatment values, post-treatment 1st month values in group B were significantly lower

GON blockade in chronic migraine Table 1 Comparison of demographics, level of education, headache localization in groups A and B Group A (n = 33) Age (years) 37.0  9.1 Height (cm) 160.7  6.3 Weight (kg) 68.2  15.0 Gender (M/F) 2/31 (6.1/93.9%) Level of completed education Illiterate 2 (6.1%) Elementary school 18 (54.5%) Middle school 1 (3%) High school 7 (21.2%) University 4 (12.1%) Distance learning 1 (3%) Headache localization Right side 9 (27.3%) Left side 9 (27.3%) Bilateral 15 (45.5%)

Group B (n = 39)

P

37.3  8.8 1614  82 682  157 5/34 (12.8/87.2%)

0.883 0.708 0.990 0.442

2 20 4 8 5 –

(5.1%) (51.3%) (10.3%) (20.5%) (12.8%)

0.685

5 (12.8%) 10 (25.6%) 24 (61.5%)

0.248

(P < 0.001), while in placebo group, there was no statistically significant difference (P = 0.223) (Fig. 2). During the second month of treatment, mean headache duration decreased significantly in group A (P < 0.001) and group B (P < 0.05). As compared to pretreatment values, 2nd month and 3rd month values were significantly lower in both groups (P < 0.001) (Table 2). When comparison was made between groups in headache durations, there was no statistical significant difference in all of the follow-up periods (P > 0.05). The mean number of headache days was significantly lower after the first month of treatment in group B, as compared to pretreatment h

Placebo

(P < 0.001). In group A, the mean number of headache days was significantly lower when compared to pretreatment (P = 0.035). When comparison was made between groups, the mean headache days were statistically significantly lower in bupivacaine group compared to placebo group (P < 0.004) (Fig. 3). The values in the third month in groups A and B were 6.7  5.2 and 5.5  4, respectively. Comparisons with pretreatment were significant in both groups (Table 3). When groups A and B were compared in the second month, mean headache frequency of group B was significantly lower than that of group A, but the third month’s results were statistically insignificant (Table 3). Pretreatment mean VAS scores in groups A and B were similar. During the first month of treatment, VAS pain scores were 6.7  1.6 cm in group A and 5.3  2.1 cm in Group B, which means there was a statistically significant difference between placebo and bupivacaine groups in the first month (P = 0.004) (Table 4). The results and comparison between placebo and bupivacaine groups during the 1st month (4 weeks) were shown in Fig. 4. During pretreatment, 1st, 3rd, 4th week differences were insignificant in placebo group and differences were significant in all follow-up periods in bupivacaine group (P > 0.05, P < 0.05, respectively) (Fig. 4). During the second month of treatment in group A, when placebo injection was changed to

Bupivacaine

25.0

20.0

15.0

10.0

5.0

0.0

Pretreatment

1. Week

2. Week

3. Week

4. Week

Figure 2. The comparison of headache duration between placebo and bupivacaine groups (mean  SD). P > 0.05 between groups comparison, P > 0.05 in group placebo in pretreatment – 1st, 2nd, 3rd, 4th week comparisons, P > 0.05 in group bupivacaine in pretreatment – 1st, 2nd week, and P < 0.05 in pretreatment – 3rd, 4th week comparisons.

273

Inan et al. Table 2 Duration of headache (hours) in groups A and B Group B (n = 39)**

Group A (n = 33)* Mean  SD Pretreatment 1st month 2nd month 3rd month

24.2 21.2 15.1 10.8

   

Median (range)

13.7 13.4 8.9 5.9

24 21 14 10

(5–48) (4–60) (3–38) (0–30)

Mean  SD 25.9 19.3 14.0 10.0

   

16.3 11.5 10.4 6.2

Median (range) 24 18 12 8

(4–72) (3–45) (0–48) (0–24)

Between groups P 0.781 0.767 0.339 0.461

Group sample sizes achieved 61.5% power to detect a 7-unit difference between groups. *P = 0.223; 1st month pretreatment comparison in group A, P < 0.001; 2nd, 3rd month pretreatment comparison. **P < 0.001; 1st month pretreatment comparison in group B, P < 0.001; 2nd, 3rd month pretreatment in group B.

Day 25

Group A:Placebo

Group B: Bupivacaine

20

*

15

10

in group B. Adverse events in response to bupivacaine GON blockade occurred in 10 patients, while seven patients experienced adverse events in response to placebo. Local pain at the site of injection occurred six times, vertigo occurred three times, and nausea occurred once in response to bupivacaine. When we take the response to placebo into consideration, pain at the site of injection side occurred twice, vertigo occurred once, back pain occurred once, and cervical neck spasm occurred twice. No severe adverse effects requiring the cessation of treatment were observed.

5

Discussion 0

Pretreatment

1.month

Figure 3. The comparison of headache frequency between placebo and bupivacaine groups (mean  SD). *P < 0.05, between groups comparison.

bupivacaine, the mean VAS pain score decreased to 4.9  1.6 cm and the difference between the pretreatment values was significant (P < 0.001). VAS pain scores in groups A and B during the third month of treatment were 4.6  1.7 and 4.7  2.6 cm, respectively. Surely, comparison with pretreatment was significant (P < 0.001) (Table 4). When we compare the groups during the first month, bupivacaine and placebo groups had different responses. Bupivacaine group showed a statistically significant decrease according to headache parameters. When we exchanged placebo group with bupivacaine, the group showed similar significant decrease with regard to headache parameters in the 3rd month. Adverse effects

GON blockade was administered 297 times in 33 patients in group A and 234 times in 39 patients 274

Hereby, the presented findings show that repeated GON blockade with bupivacaine significantly decreased the number of headache days, headache duration, and VAS pain scores in patients with CM compared to placebo. When the patients in group A were administered bupivacaine GON blockade, a significant decrease in parameter values was noted. These changes were gone beyond estimated bupivacaine effectiveness. After weekly blockade with bupivacaine, monthly GON blockade showed efficacy and decrement on those parameters as well. In total, 84 patients were enrolled in the study, but only 72 completed it. Two patients did not complete the study because they switched to different treatment facilities. There were no instances of adverse effects that required the cessation of treatment in the present study, the adverse effects reported were as follows: pain at the site of injection, vertigo, and nausea were reported in both groups. GON blockade appears to be effective in many patients with migraine, although controlled studies have not been published. To our knowledge, this is the first placebo-controlled study in chronic migraine treatment with GON blockade, so this underlines the comparison and discussion of the results with the literature.

GON blockade in chronic migraine Table 3 Comparison of the number of headache days in groups A and B Group B (n = 39)**

Group A (n = 33)* Mean  SD Pretreatment 1st month 2nd month 3rd month

16.9 13.2 8.4 6.7

   

Mean  sd

Median (range)

5.7 6.7 5.0 5.2

15 13 8 6

(7–30) (3–28) (1–28) (0–30)

18.1 8.8 6.6 5.5

   

Median (range)

5.3 4.8 4.7 4

18 8 5 4

(8–30) (1–22) (0–21) (0–19)

Between groups P 0.380 0.004 0.039 0.216

Group sample sizes achieved 92.8% power to detect a 6.8-day difference between groups. *P < 0.001; 2nd and 3rd month pretreatment comparison in group A. **P < 0.001; 2nd and 3rd month pretreatment comparison in group B.

Table 4 VAS pain scores in groups A and B Group A (n = 33)* Mean  SD Pretreatment Mean VAS pain score during the 1st month of treatment Mean VAS pain score during the 2nd month of treatment Mean VAS pain score during the 3rd month of treatment

8.1 6.7 4.9 4.6

   

Group B (n = 39)** Mean  sd

Median (range)

0.9 1.6 1.6 1.7

8 7 5 5

(5–9.5) (3–9) (1–8) (0–7.5)

8.4 5.3 5.2 4.7

   

1.5 2.1 2.6 2.6

Median (range) 9 5 5 4

(3.5.10) (1.9) (0.10) (0.10)

Between group P 0.062 0.004 0.345 0.985

Group sample sizes achieved 90.6% power to detect a 2.3-unit difference between groups. *P < 0.001; 2nd and 3rd month pretreatment comparison in group A. **P < 0.001; 2nd and 3rd month pretreatment in group B.

VAS 10.00

Group A: PLACEBO

Group B: BUPIVACAINE

*

9.00

*

8.00 7.00 6.00 5.00 4.00 3.00 2.00 1.00 0.00

Pretreatment

1. Week

2. Week

3. Week

4. Week

Figure 4. The comparison of VAS values between placebo and bupivacaine groups. *P < 0.05 between groups comparison. P > 0.05 in placebo group in pretreatment – 1st, 3rd, 4th week comparison, P = 0.014 in pretreatment – 2nd week comparison. P < 0.001 in bupivacaine group in pretreatment – 1st, 2nd, 3rd, 4th week comparison.

Headache durations were significantly lower in bupivacaine group, while there was no significant decrease in placebo group in the 1st month. Comparison between groups was not significant.

Short duration of follow-up of placebo and small number of cases might be the reason for this. Number of headache days and VAS scores were significantly lower in bupivacaine group 275

Inan et al. than placebo group. After switching from placebo to bupivacaine, although the number of headache days in both groups was similar in the 3rd month, VAS scores were alike in both groups in the 2nd and 3rd month. These findings show that bupivacaine is superior to placebo, and after blindness was removed and shifted to bupivacaine, both groups had become similar in the 3rd month. A study that included 19 patients with acute migraine and allodynia reported that headache pain was relieved in 17 patients and allodynia decreased in all patients (6). In another study, it was reported that 26 of 57 GON injections in 54 migraine patients yielded complete or partial response that lasted for a median of 30 days (7). A placebo-controlled study on the benefits of GON blockade for chronic daily headache was positive (8). The efficacy of GON blockade in the treatment of various types of headache has been assessed in a number of studies (9–18). However, few of these studies were controlled studies. In one of the few randomized controlled studies on the efficacy of GON blockade for headache, Ambrosini et al.’s (19) double-blind, placebo-controlled study of GON blockade (ipsilateral to the pain side in cluster headache patients) reported that 80% of the treatment group responded, versus 0% of the placebo group (which received saline injection). Afridi et al. (7). examined the efficacy of GON blockade in 101 patients with refractory chronic daily headache of various etiologies. In all, 22% of the injections resulted in a complete response (pain free), and an additional 31% resulted in partial response. The median duration of complete response was 7 days and that of partial response was 20 days. Weibelt et al. (10). studied suboccipital nerve blockade for suppression of chronic migraine. Their study was not blinded and lacked a control therapy group active or placebo. They treated 150 consecutive patients with chronic migraine. In the 1st month followup visit, 78 (52%) patients exhibited evidence of positive treatment response, according to the primary outcome variable, and 90 (60%) patients reported that their headache disorder was better or much better. In the present study, headache days had decreased from 18.1 to 8.8 (51.4%) in bupivacaine group, and from 16.9 to 13.2 (21.9%) in the placebo group in the 1st month in chronic migraine diagnosed patients. The positive clinical effect of GON injection seemed to exceed very considerably the half-life of the local anesthetic. The response to GON blockade was not simply dependent on the direct 276

local anesthetic effect of the injection (8). The mechanism of action might have been via changes in brain nociceptive pathways. Another possible explanation for these findings is, therefore, that GON injections initiated diffuse noxious inhibitory controls, independent of anesthetic effect (2). Neurophysiological and clinical data suggest there is a functional connection between the sensory occipital segments and the trigeminal nociceptive system in humans. GON blockade for migraine and, in particular in unresponsive CM, should therefore be considered an effective management tool. The trigeminocervical complex is connected to the nucleus salivatorius with the raphe nucleus, the locus coeruleus, and, consequently, with the hypothalamus. In addition, painful stimuli originating from cranial structures are transmitted via the trigeminal nerve and superior cervical nerves to the trigeminocervical complex, and then to upper centers (20). According to recent investigations, nerve blockade of the trigeminocervical complex is a promising alternative for the treatment of headache (21). In the present study, although weekly and monthly treatments are similarly effective, it should be mentioned that patients responded well to once-monthly treatment, and it is more feasible than once-weekly treatment. This treatment appeared to be very rapid and cost-effective when compared to other treatments proposed for chronic migraine especially when compared with BoNT-A. A number of factors, including study design, local anesthetic dosage, application method, and number of applications, might play a role in such differences. As this study is a preliminary study, the short duration of double-blind phase makes the results not comparable to other studies that had already been published in chronic migraine field. As a result of this study, it can be said that greater occipital nerve blockade is an effective treatment modality in chronic migraine which decreases the need for adjuvant medical treatments for pain; also it protects the patient from serious complications secondary to the side effects of the drugs; and it provides an improved health status for the patients via a simple, safe, and economic method. The present findings indicate that repeated GON injection with bupivacaine can be included in the management of chronic migraine. Acknowledgment None.

GON blockade in chronic migraine Conflict of interest None.

11.

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Greater occipital nerve blockade for the treatment of chronic migraine: a randomized, multicenter, double-blind, and placebo-controlled study.

We aimed to assess the efficacy of greater occipital nerve (GON) blockade at chronic migraine (CM) treatment...
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