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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203294
First received: September 13, 2005
Last updated: April 7, 2014
Last verified: April 2014
  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:


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
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

No publications provided

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 Disorders, Primary
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Anesthetics, Local
Bupivacaine
Lidocaine
Anesthetics
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on August 19, 2014