Greater Occipital Nerve Block for Migraine Prophylaxis
|ClinicalTrials.gov Identifier: NCT00915473|
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : February 25, 2014
Last Update Posted : March 20, 2014
Migraine is a common neurological condition that can be disabling, particularly if chronic. Greater occipital nerve (GON) block has been utilized for decades for the treatment of migraine in the absence of a single randomized, placebo-controlled trial documenting its effectiveness.
Hypothesis: Greater occipital nerve block reduces the frequency of days with moderate or severe headache in patients with episodic or chronic migraine.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Drug: bupivicaine Drug: normal saline Drug: methylprednisolone Drug: lidocaine||Phase 4|
Migraine is a common disease with lifetime prevalence in women and men of 33% and 12% respectively. Chronic migraine affects 2% of the US population and is highly disabling. There are no FDA approved medications for the treatment of chronic migraine.
Although some patients benefit from a daily prophylactic medication, others continue to suffer from severe, frequent, debilitating headaches. Limited efficacy, poor compliance, side effects and drug-drug interactions may explain why more than 80% of migraineurs in the population are not prescribed daily prophylactic medications.
Occipital nerve injections with corticosteroids and/or local anesthetics have been employed for the acute and prophylactic treatment of migraine, cervicogenic headache and cluster headache for decades. A long-acting anesthetic and corticosteroid are often combined, although anesthetic agents have also been used alone. However, there are no randomized controlled trials evaluating the preventive efficacy of occipital nerve block in subjects with migraine.
Patients were equally randomized to receive either 2.5 ml 0.5% bupivacaine plus 0.5 ml 20 mg methylprednisolone over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve or 2.75 ml normal saline plus 0.25 ml 1% lidocaine without epinephrine (placebo). The GON injection site was at the medial third of the distance between the occipital protuberance and the mastoid process. Patients were evaluated after the 4-week baseline diary completion phase to undergo the injection, and for 4 weeks after the injection. Therefore, there were 3 patient visits in this study: screening, injection and 4-week follow-up. In an effort to ensure adequate blinding, 0.25 ml of short-acting 1% lidocaine without epinephrine was used as the placebo arm. In order to ensure adequate blinding of the investigator, each syringe and needle hub was covered with opaque tape so as to ensure blinding of the investigator providing the injection. A total of four investigators provided injections. The blinded investigator who evaluated the study subject 4 weeks after injection may or may not be the same as the investigator who provided the injection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Greater Occipital Nerve Block for Migraine Prophylaxis|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Experimental: Active Injection
Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
2.5 mL 0.5% bupivicaine
Other Names:Drug: methylprednisolone
0.5 mL 20 mg methylprednisolone
Placebo Comparator: Placebo Injection
Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
Drug: normal saline
2.75 mL normal salineDrug: lidocaine
0.25 mL 1% lidocaine
Other Name: xylocaine
- Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period [ Time Frame: 4 weeks pre-injection baseline, 4 weeks post-injection ]The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.
- Mean Frequency of Days With a Migraine [ Time Frame: 4 weeks post-injection ]
- Mean Number of Hours With Moderate or Severe Migraine [ Time Frame: 4 weeks post-injection ]
- Mean Number of Days With Acute Medication Use [ Time Frame: 4 weeks post-injection ]Acute medication use meant "the consumption of a drug to abort or terminate a headache."
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915473
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|Principal Investigator:||David W. Dodick, M.D.||Mayo Clinic|