Research Study of Greater Occipital Nerve Block As A Treatment For Prolonged Migraine Attacks

Migraine Clinical Trial

Official title:

Double-Blind, Placebo Controlled Trial Of Greater Occipital Nerve Block For The Treatment Of Migraine Status

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00329732
• Other study ID #: GON-DBPC/WBY
• Status: Terminated
• Phase: N/A
• First received: May 24, 2006
• Last updated: April 16, 2015
• Start date: March 2006
• Est. completion date: April 2006

Study information

• Verified date: April 2015
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of headache. The GONB procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). The purpose of this study is to determine whether GONB is effective for the treatment of prolonged migraine attacks. This study is placebo controlled, which means that half of the patients participating will receive injections of active study drug (lidocaine plus bupivicaine) and half of the patients will receive injections of saline (placebo). The study is also blinded which means that neither you nor the study staff will know whether you received active study drug or placebo. The study remains blinded only for the first 30 minutes, at which point additional treatments (including GONB) can be administered at the discretion of your treating physician.

40 patients are expected to participate in this research study. This study is being conducted at Thomas Jefferson University only.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects, male or female, between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling IHS criteria for episodic migraine

• Presenting to clinic in migraine status, meaning the migraine has continued for greater than or equal to 3 days but less than 3 months.

• Pain must be reported as at least moderate pain level at time of injections

Exclusion Criteria:

A subject is ineligible to participate in this study if he/she satisfies any of the following criteria:

• Subjects who have received greater occipital nerve blocks in the past

• Subjects who in their own or the investigator's opinion are unable to describe their symptoms

• Subjects who are pregnant or lactating

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• 0.5% bupivicaine and 2% lidocaine
The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion. If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally. If the headache is strictly unilateral, the block will be performed only on the side of the headache
• Saline placebo
matching volume of saline (placebo)

Locations

Country	Name	City	State
United States	Jefferson Headache Center/Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.		30 minutes	No
Secondary	Secondary Measures Include:Percentage of Subjects Achieving a Significant Change on a 10 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo;		30 minutes	No
Secondary	Percentage of Subjects Achieving a Significant Change on a 100mm Visual Analogue Scale (VAS) at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Greater Than or Equal to 2cm Change.		30 minutes	No
Secondary	Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured During the First 30 Minutes Post-injection, Active Drug Versus Placebo;		30 minutes	No