MigraineNCT00203294
A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache
A study testing lidocaine, bupivicaine and saline and lidocaine plus bupivicaine plus triamcinolone (steroid) in people with Migraine, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- lidocaine, bupivicaine and saline and lidocaine plus bupivicaine plus triamcinolone (steroid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
About this study
Official title: Comparison Of Greater Occipital Nerve Block With Lidocaine And Bupivicaine Alone Or With Steroids In a Chronic Headache Population
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
- Being tested
- lidocaine, bupivicaine and saline, lidocaine plus bupivicaine plus triamcinolone (steroid)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine, bupivicaine and salineDrug
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 plus bupivicaine plus triamcinolone (steroid)Drug
Also called Kenalog
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: lidocaine plus bupivicaine plus triamcinolone (steroid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen D Silberstein, MD, Principal investigator, Thomas Jefferson University, Jefferson Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203294
- Sponsor's protocol ID
- GONB/ STE/ 01
- Status last verified
- Apr 2014
- First submitted
- 13 Sep 2005
- Last updated
- 7 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Greater Occipital Nerve Block With Lidocaine And Bupivicaine Alone Or With Steroids In a Chronic Headache Population
- ClinicalTrials.gov ID
- NCT00203294
- Acronym / sponsor ID
- GONB/ STE/ 01
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 7 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 2%, Bupivicaine 0.5% and saline | Active comparator | Drug: lidocaine, bupivicaine and salineAdult 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. |
| Lidocaine 2%, Bupivicaine 0.5% and triamcinolone 40 mg | Active comparator | Drug: lidocaine plus bupivicaine plus triamcinolone (steroid)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine, bupivicaine and salinelidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc. | Drug | Lidocaine 2%, Bupivicaine 0.5% and saline |
| lidocaine plus bupivicaine plus triamcinolone (steroid)Also: Kenaloglidocaine, bupivicaine and triamcinolone (steroid)-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc. | Drug | Lidocaine 2%, Bupivicaine 0.5% and triamcinolone 40 mg |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D Silberstein, MD principal investigator
Thomas Jefferson University, Jefferson Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine, bupivicaine and saline and lidocaine plus bupivicaine plus triamcinolone (steroid) in people with Migraine, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.