Greater Occipital Nerve Block for Migraine Prophylaxis

February 24, 2014 updated by: Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects meet diagnostic criteria for episodic migraine or chronic migraine according to the International Headache Classification II (ICHD-II)
  • Migraine sufferers who experience at least 1 attack per week
  • Able to read and understand the requirements of the study, abide by any restrictions, and return for the required examinations
  • Able and willing to sign an informed consent statement
  • Subjects must be in generally good health as confirmed by medical history, medication review, baseline physical examination, vital signs and clinical laboratory evaluations.

Exclusion Criteria:

  • Subjects with continuous headache (no headache free periods)
  • Subjects using maintenance opioid medication
  • Subjects who have started a medication with prophylactic migraine efficacy within the past 2 months
  • Known hypersensitivity or allergic reaction to any of study ingredients (lidocaine, bupivicaine, any local anesthetics, and corticosteroids) or betadine.
  • Use of any investigational medication within 90 days of the initial screening visit and/or concurrent enrolment in an investigational study
  • Injection site infection or systemic infection at the injection visit (afebrile at time of injection)
  • Presence of cranial bone defect
  • Subjects with chronic cluster headache, new daily persistent headache, hemicrania continua, or chronic tension type headache
  • Subjects with a history of an unstable medical condition (e.g. cardiovascular, hepatic, renal, endocrine) that may impair their reliable participation in the study or necessitate the use of medications not permitted in this study
  • Subjects with a history (within the past 6 months) of a major psychiatric disorder that in the opinion of the investigator may preclude the subject from completed the requirements of the study
  • Female subjects who are pregnant or nursing
  • Subjects with a history of drug or alcohol abuse within the past 2 years
  • Subjects with a history of poor compliance with past drug therapies, as judged by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: bupivicaine
2.5 mL 0.5% bupivicaine
Other Names:
  • Marcaine
  • Sensorcaine
  • Marcain
  • Vivacaine
Drug: methylprednisolone
0.5 mL 20 mg methylprednisolone
Other Names:
  • Medrol
  • Solu-Medrol
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 saline
Drug: lidocaine
0.25 mL 1% lidocaine
Other Names:
  • xylocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks pre-injection baseline, 4 weeks post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Frequency of Days With a Migraine
Time Frame: 4 weeks post-injection
4 weeks post-injection
Mean Number of Hours With Moderate or Severe Migraine
Time Frame: 4 weeks post-injection
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."
4 weeks post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: David W. Dodick, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-008203
  • UL1TR000135 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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