Clinical trial NCT00203294: A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache
Official title: Comparison Of Greater Occipital Nerve Block With Lidocaine And Bupivicaine Alone Or With Steroids In a Chronic Headache Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain
timeFrame: 20 minutes
measure: 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.
timeFrame: 20 minutes
Secondary outcomes:
measure: To Evaluate the Effect of Treatment on Neck Pain in the Two Groups Compared to Historical Baseline, and Between the Two Treatment Groups.
timeFrame: 20 minutes
measure: 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.
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University, Jefferson Headache Center
name: Stephen D Silberstein, MD
role: PRINCIPAL_INVESTIGATOR
References: