Migraine
Conditions
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.
Interventions
DRUGlidocaine, 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.
DRUGlidocaine 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.
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain | 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. | 20 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GON Block Only Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc. | 22 |
| GON Block Plus Steroid Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc. | 23 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 13 |
Baseline characteristics
| Characteristic | GON Block Only | GON Block Plus Steroid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 23 Participants | 45 Participants |
| Region of Enrollment United States | 22 participants | 23 participants | 45 participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 37 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 |
Outcome results
Primary
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
Primary
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
Time frame: 20 minutes
Population: There were 15 patients in group A (no steroids injected) and 14 in group B (steroids injected).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine 2% and Bupivacaine 0.25% Plus Saline | Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain | -3.29 units on a scale | Standard Deviation 2.76 |
| Lidocaine 2% and Bupivacaine 0.25% Plus Triamcinolone 40 mg. | Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain | -3.70 units on a scale | Standard Deviation 1.49 |
Comparison: Fisher's exact test was used to compare nominal variables between groups. The Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.p-value: <0.01Fisher Exact
Comparison: Fisher's exact test was used to compare nominal variables between groups.p-value: <0.01Fisher Exact
Secondary
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
Secondary
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