L E Inan1, N Inan2, Ö Karadaş3, H L Gül4, A K Erdemoğlu5, Y Türkel5, A Akyol6. 1. Ministery of Health, Neurology Department, Ankara Research and Training Hospital, Ankara, TR. 2. Anesthesiology Algology Department, Gazi University, Ankara, TR. 3. Ankara Mevki Military Hospital, Ankara, TR. 4. Neurology Department, Fatih University Medical Faculty, Istanbul, TR. 5. Neurology Department, Kırıkkale University, Kırıkkale, TR. 6. Neurology Department, Adnan Menderes University, Aydın, TR.
Abstract
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.
RCT Entities:
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.