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

Purpose

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	Intervention
Migraine	Drug: lidocaine, bupivicaine and saline Drug: lidocaine plus bupivicaine plus triamcinolone (steroid)


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Comparison Of Greater Occipital Nerve Block With Lidocaine And Bupivicaine Alone Or With Steroids In a Chronic Headache Population

Resource links provided by NLM:

MedlinePlus related topics: Headache

Drug Information available for: Triamcinolone diacetate Lidocaine hydrochloride Triamcinolone acetonide Triamcinolone Lidocaine Triamcinolone hexacetonide Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Enrollment:	45
Study Start Date:	June 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

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: NCT00203294

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


Responsible Party:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00203294 History of Changes
Other Study ID Numbers:	GONB/ STE/ 01
Study First Received:	September 13, 2005
Results First Received:	May 19, 2011
Last Updated:	April 7, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Headache Disorders Headache Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Brain Diseases Central Nervous System Diseases Lidocaine Bupivacaine 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

Headache Disorders
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Lidocaine
Bupivacaine
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

ClinicalTrials.gov processed this record on September 23, 2016