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

This study has been terminated.
(Study terminated due to inadequate recruitment)
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00329732
First received: May 24, 2006
Last updated: July 21, 2011
Last verified: July 2011

May 24, 2006
July 21, 2011
March 2006
April 2006   (final data collection date for primary outcome measure)
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. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT00329732 on ClinicalTrials.gov Archive Site
  • 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; [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • 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; [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • 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;
  • 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.
  • Difference in the use of additional pain medication during the 24 hours post-injection, active drug versus placebo;
  • 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;
  • Percentage of subjects with purely frontal headaches who improve compared to percentage of patients with headache pain located anywhere else so long as it is not located only in the frontal region
Not Provided
Not Provided
 
Research Study of Greater Occipital Nerve Block As A Treatment For Prolonged Migraine Attacks
Double-Blind, Placebo Controlled Trial Of Greater Occipital Nerve Block For The Treatment Of Migraine Status

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine
  • 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
  • Drug: Saline placebo
    matching volume of saline (placebo)
  • Active Comparator: Lidocaine/Bupivicaine
    Intervention: Drug: 0.5% bupivicaine and 2% lidocaine
  • Placebo Comparator: saline
    matching volume of saline injected
    Intervention: Drug: Saline placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00329732
GON-DBPC/WBY
Not Provided
Bruce Smith, Thomas Jefferson University
Thomas Jefferson University
Not Provided
Principal Investigator: William B Young, M.D. Jefferson Headache Center
Thomas Jefferson University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP