A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache

Study Description

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Brief Summary:

Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for your chronic daily headache (CDH). GONB has been used for many years in the treatment of headaches. The nerve block is done by injecting a liquid drug through the skin of the back of the head to the area of the greater occipital nerve. The nerve runs superficially in this area, therefore the drugs are injected just under the skin. The injected drugs block electrical transmission through the nerve, resulting in reduced head pain. There are treatment options for patients receiving a GONB, however, some clinicians use local anesthetics (lidocaine and /or bupivicaine) alone, and some use local anesthetics with local steroid injection. The purpose of this study is to evaluate whether or not there is an observed difference between these two treatment approaches for GONB. We expect to enroll 60 patients into this research study at Thomas Jefferson University only.

Condition or disease	Intervention/treatment	Phase
Migraine	Drug: lidocaine, bupivicaine and saline; Drug: lidocaine plus bupivicaine plus triamcinolone (steroid)	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	45 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Comparison Of Greater Occipital Nerve Block With Lidocaine And Bupivicaine Alone Or With Steroids In a Chronic Headache Population
Study Start Date :	June 2005
Actual Primary Completion Date :	June 2006
Actual Study Completion Date :	June 2006

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Lidocaine 2%, Bupivicaine 0.5% and saline; Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally.	Drug: lidocaine, bupivicaine and saline; lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.
Active Comparator: Lidocaine 2%, Bupivicaine 0.5% and triamcinolone 40 mg; Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally.	Drug: lidocaine plus bupivicaine plus triamcinolone (steroid); lidocaine, bupivicaine and triamcinolone (steroid)-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.; Other Name: Kenalog

Outcome Measures

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Primary Outcome Measures :

1. Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain [ Time Frame: 20 minutes ]
   Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment
2. Decrease in Headache Pain, as Measured on an 11-point Pain Scale (0=no Pain, 10=Excruciating Pain). Change in Headache Pain 20 Minutes After Injection Will be Compared Between Treatment Groups. [ Time Frame: 20 minutes ]

Secondary Outcome Measures :

1. To Evaluate the Effect of Treatment on Neck Pain in the Two Groups Compared to Historical Baseline, and Between the Two Treatment Groups. [ Time Frame: 20 minutes ]
2. To Evaluate Effect of Treatment on Associated Symptoms (Nausea, Phonophobia and Photophobia) as Measured Using a 4 Point Scale (None, Mild, Moderate, Severe) Compared to Historical Baseline, and Between the Two Treatment Groups. [ Time Frame: 20 minutes ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Adult patients, age 18-65 inclusive
• Patients who have chronic daily headache (15 or more headache days per month) for at least 3 months prior to enrollment in the study.
• Headache level should be 5/10 or more at time of GON block.
• Patients should have posterior cervical muscle tenderness at time of nerve block.

Exclusion Criteria:

• Patients who had surgery or any other invasive procedure in the occipital area.
• Patients with abnormal sensory findings on examination or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
• Patients diagnosed with cluster headache
• Patients with skin diseases that may affect skin sensation.
• Patients who are cognitively impaired.
• Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
• Patients who are pregnant or breast-feeding.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:	Stephen D Silberstein, MD	Thomas Jefferson University, Jefferson Headache Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00203294 History of Changes
Other Study ID Numbers:	GONB/ STE/ 01
First Posted:	September 20, 2005
Results First Posted:	May 7, 2014
Last Update Posted:	May 7, 2014
Last Verified:	April 2014

Additional relevant MeSH terms:

Headache Disorders; Headache; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Bupivacaine; Lidocaine; Triamcinolone hexacetonide; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; 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; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunosuppressive Agents