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

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lidocaine, bupivicaine and saline
lidocaine plus bupivicaine plus triamcinolone (steroid)
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jefferson Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lidocaine 2%, Bupivicaine 0.5% and saline

Lidocaine 2%, Bupivicaine 0.5% and triamcinolone 40 mg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain
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.

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.
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.

Full Information

First Posted
September 13, 2005
Last Updated
April 7, 2014
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT00203294
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine 2%, Bupivicaine 0.5% and saline
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lidocaine 2%, Bupivicaine 0.5% and triamcinolone 40 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lidocaine, bupivicaine and saline
Intervention Description
lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.
Intervention Type
Drug
Intervention Name(s)
lidocaine plus bupivicaine plus triamcinolone (steroid)
Other Intervention Name(s)
Kenalog
Intervention Description
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.
Primary Outcome Measure Information:
Title
Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain
Description
Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment
Time Frame
20 minutes
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen D Silberstein, MD
Organizational Affiliation
Thomas Jefferson University, Jefferson Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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