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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:
Thomas Jefferson University
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00329732
First received: May 24, 2006
Last updated: April 16, 2015
Last verified: April 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| Migraine | Drug: 0.5% bupivicaine and 2% lidocaine Drug: Saline placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Double-Blind, Placebo Controlled Trial Of Greater Occipital Nerve Block For The Treatment Of Migraine Status |
Resource links provided by NLM:
Further study details as provided by Thomas Jefferson University:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
- 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 ]
- 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 ]
| Enrollment: | 2 |
| Study Start Date: | March 2006 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Lidocaine/Bupivicaine |
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
|
|
Placebo Comparator: saline
matching volume of saline injected
|
Drug: Saline placebo
matching volume of saline (placebo)
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329732
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329732
Locations
| United States, Pennsylvania | |
| Jefferson Headache Center/Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
Sponsors and Collaborators
Thomas Jefferson University
Investigators
| Principal Investigator: | William B Young, M.D. | Jefferson Headache Center |
More Information
| Responsible Party: | Bruce Smith, Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00329732 History of Changes |
| Other Study ID Numbers: |
GON-DBPC/WBY |
| Study First Received: | May 24, 2006 |
| Results First Received: | May 24, 2011 |
| Last Updated: | April 16, 2015 |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Lidocaine Bupivacaine Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 18, 2017