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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| ClinicalTrials.gov Identifier: NCT00203294 |
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Recruitment Status :
Completed
First Posted : September 20, 2005
Results First Posted : May 7, 2014
Last Update Posted : May 7, 2014
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Sponsor:
Thomas Jefferson University
Information provided by (Responsible Party):
Thomas Jefferson University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Migraine | Drug: lidocaine, bupivicaine and saline Drug: lidocaine plus bupivicaine plus triamcinolone (steroid) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 45 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison Of Greater Occipital Nerve Block With Lidocaine And Bupivicaine Alone Or With Steroids In a Chronic Headache Population |
| Study Start Date : | June 2005 |
| Actual Primary Completion Date : | June 2006 |
| Actual Study Completion Date : | June 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Headache
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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 |
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 ]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 ]
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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00203294 History of Changes |
| Other Study ID Numbers: |
GONB/ STE/ 01 |
| First Posted: | September 20, 2005 Key Record Dates |
| Results First Posted: | May 7, 2014 |
| Last Update Posted: | May 7, 2014 |
| Last Verified: | April 2014 |
Additional relevant MeSH terms:
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Headache Disorders Headache Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Brain Diseases Central Nervous System Diseases Bupivacaine Lidocaine 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 |