Greater Occipital Nerve Block for Migraine Prophylaxis
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): bupivicaine; normal saline; methylprednisolone; lidocaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2.5 mL 0.5% bupivicaine; 2.75 mL normal saline; 0.5 mL 20 mg methylprednisolone; 0.25 mL 1% lidocaine
Other intervention name(s): Marcain; Marcaine; Sensorcaine; Vivacaine; Medrol; Solu-Medrol; xylocaine
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Lidocaine; Bupivacaine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment