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

NCT00203294 | Completed Results

• 1 other identifier: GONB/ STE/ 01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• 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

  20 minutes

• 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.

  20 minutes

Secondary Outcomes (2)

• To Evaluate the Effect of Treatment on Neck Pain in the Two Groups Compared to Historical Baseline, and Between the Two Treatment Groups.

  20 minutes

• 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.

  20 minutes

Study Arms (2)

Lidocaine 2%, Bupivicaine 0.5% and saline

ACTIVE COMPARATOR

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 2%, Bupivicaine 0.5% and triamcinolone 40 mg

ACTIVE COMPARATOR

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)

Interventions

lidocaine, bupivicaine and saline DRUG

lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.

Lidocaine 2%, Bupivicaine 0.5% and saline

lidocaine plus bupivicaine plus triamcinolone (steroid) DRUG

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.

Also known as: Kenalog

Lidocaine 2%, Bupivicaine 0.5% and triamcinolone 40 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Lidocaine; Sodium Chloride; Triamcinolone; Steroids; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Kathleen Bradley
• Organization: Thomas Jefferson University

Kathleen.Bradley@Jefferson.edu

215-955-2025

Study Officials

• Stephen D Silberstein, MD

  Thomas Jefferson University, Jefferson Headache Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: May 7, 2014
• Results First Posted: May 7, 2014

Record last verified: 2014-04

Locations

US (1)