Chronic Migraine, Headache, Episodic Migraine
Conditions
Keywords
Pain, Chronic Migraine, Episodic Migraine, Headache, Nerve Block
Brief summary
Migraine affects 10-28% of children and adolescents and yet 20-30% of patients are ineffectively treated with current oral and nasal options. Peripheral nerve blocks (PNBs), injections of local anesthetics over branches of the occipital and/or trigeminal nerves, have been associated with possible benefit for pediatric headaches in case series, and may be useful for both acute and preventive treatment of migraine for children who fail less invasive treatments. In fact, 80% of pediatric headache specialists reported using peripheral nerve blocks and carry low risk of serious side effects; however, peripheral nerve blocks have never been tested, formally, in a randomized pediatric trial. By applying a novel design that utilizes lidocaine cream as a run-in step, investigators intend to test the efficacy of the most commonly used peripheral nerve block, the greater occipital nerve (GON) block, as an acute treatment for pediatric migraine and determine whether lidocaine cream leads to successful blinding of the injection. The GON block is expected to prove effective in decreasing the pain of migraine, with lidocaine being superior to saline and lidocaine cream maintaining blinding.
Detailed description
There are two substantial hurdles that must be overcome in designing a trial to test the efficacy of PNBs: high placebo response rate and possible unblinding. In order to test the efficacy of this commonly used treatment for children and adolescents with difficult-to-treat headache, we need utilize a trial design which will address the high placebo response rate and the potential lack of blinding. About 194 children, recruited over a 3.5 year period at Children's Hospital of Philadelphia, will take part in this study. Participation will last about one month and involve one in-person study visit, and then completion of headache-related surveys, at home, for 28 days. Lidocaine cream lead-in will be used open-label for all subjects followed by double-blind randomized injections of active treatment (lidocaine) versus comparator (saline) in subjects who continue to have significant headache. To accomplish our secondary objectives, we will examine how expectation is affected by perceived treatment, and how expectations, measured in patients, parents, and providers, influence outcomes in pediatric and adolescent acute migraine.
Interventions
DRUGLidocaine 4% Topical Application Cream [LMX 4]
Run-in Step: All subjects receive 32 mg (4 cm ribbon of cream) applied, bilaterally, over greater occipital nerve.
DRUGLidocaine Hydrochloride 2 mg/mL Injectable Solution
Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment.
DRUGNormal Saline
Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, double-blind greater occipital nerve injection of lidocaine versus saline after open-label lidocaine cream run-in
Eligibility
Sex/Gender
ALL
Age
7 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Children / Adolescents: * Males or females, ages 7 - 21, of any gender, race, or ethnicity * Diagnosis of episodic or chronic migraine with acute headache flare lasting up to 3 months unresponsive to acute medications. Patients who report that acute medications were not used during this headache flare because those medications have been ineffective for several prior headache flares will be included * Informed parental consent and subject assent * Girls, who have reached menarche, must have a negative urine or serum pregnancy test * Weight \> 25kg * Parents: * Parents or guardians of children enrolled, who speak either English or Spanish, and provide parental/guardian permission (informed consent) for their own participation * Subject (child) assent
Exclusion criteria
* Children / Adolescents: * Previous nerve block less than 3 months ago or more than 2 previous nerve blocks * Allergy to local anesthetics * Skull defect or break in the skin at the planned site of cream application or GON injection * Any investigational drug use within 30 days prior to enrollment, or 90 days prior to enrollment for medications targeted at Calcitonin Gene-Related Peptide * Pregnant or lactating females * Parents/guardians or subjects who, in the opinion of the Investigator, may be non- compliant with study schedules or procedures * Significant adverse event with prior injection or procedure * New abnormalities on physical or neurological examination * Newly reported red flags in headache history which prompt investigation for secondary headache * Non-English and Non-Spanish speaking * Non-English speaking with no Spanish interpreter available * Parents: * Parents or guardians of children enrolled, who do not speak either English or Spanish * Parental/guardian permission and/or subject (child) assent has been declined * Parents or guardians, who in the opinion of the investigator, may be non-compliant or unable to complete the questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race | score on a scale | By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By race. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning the worse pain imaginable. |
| Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) | Pre-injection (*Baseline*) and 30 minutes Post-injection | By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning the worse pain imaginable. A mean change of 2-points has been shown to be clinically relevant. |
| Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) | Pre-injection and 30 minutes Post-injection | By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning the worse pain imaginable. |
| Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Sex | Pre-injection (*Baseline*) and 30 minutes Post-injection | By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By sex. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning the worse pain imaginable. A mean change of 2-points has been shown to be clinically relevant. |
| Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Sex | Pre-injection and 30 minutes Post-injection | By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By sex. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning the worse pain imaginable. |
| Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Ethnicity | Pre-injection (*Baseline*) and 30 minutes Post-injection | By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By ethnicity. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning the worse pain imaginable. A mean change of 2-points has been shown to be clinically relevant. |
| Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Ethnicity | Pre-injection and 30 minutes Post-injection | By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By ethnicity. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning the worse pain imaginable. |
| Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race | Pre-injection (*Baseline*) and 30 minutes Post-injection | By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By race. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning the worse pain imaginable. A mean change of 2-points has been shown to be clinically relevant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Disability | Baseline and Week 4 | The PedMIDAS will assess changes in functional disability due to headache. The PedMIDAS is a validated 6-question scale that captures headache-related disability-across multiple domains of functioning including school, home, social, and recreational-for pediatric and adolescent aged patients over 3 months. The instrument measures the number of days in which subjects missed activities due to headache or migraine. The measure yields a total score by summing items ranging from 0 to 90 day. The higher the score the higher the disability. Change in total score (total at week 4 minus total at baseline) is reported. |
| Change From Baseline Disability to Day 7 | Baseline and Day 7 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (Short Form) will assess changes in functional disability due to headache. The PROMIS Pain Interference (Short Form) measures the self-reported consequences of pain on relevant aspects of the subject's life over the past seven days. A pain item pool was developed to yield scores on a T-score scale with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more pain interference, a T-score of 60 is one standard deviation (SD) worse than average. By comparison, a pain interference T-score of 40 is one SD better than average. |
| Change From Baseline Disability to Week 4 | Baseline and Week 4 | The PROMIS Pain Interference (Short Form) will assess changes in functional disability due to headache. The PROMIS Pain Interference (Short Form) measures the self-reported consequences of pain on relevant aspects of the subject's life over the past seven days. A pain item pool was developed to yield scores on a T-score scale with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average. |
| Percentage of Subjects With Pain Freedom | 30 minutes Post-injection | The measurement involves resolution of headache pain within 30 minutes after injection and prior to any rescue medications. Data will be collected prospectively from subjects, at the study visit. |
| Percentage of Subjects With Pain Relief or Headache Response | 30 minutes Post-injection | The measurement involves improvement in headache from severe or moderate to none or mild within 30 minutes and before any rescue medications. Data will be collected prospectively from subjects at the study visit. |
| Percentage of Subjects With Sustained Pain Freedom | 24 hours Post-injection | The measurement involves being pain-free within 30 minutes and lasting at least 24 hours, with no use of rescue medication and no relapse or recurrence. Data will be collected prospectively from subjects, via text, in an electronic headache diary. |
| Percentage of Subjects With Sustained Pain Relief | 24 hours Post-injection | The measurement involves having pain-relief within 30 minutes and lasting at least 24 hours, with no use of rescue medication and no relapse or recurrence. Data will be collected prospectively from subjects, via text, in an electronic headache diary. |
| Percentage of Subjects With Freedom From All Symptoms of Migraine | 24 hours Post-injection | The presence or absence of photophobia, phonophobia, and nausea will be collected from subjects prospectively, via text, in an electronic headache diary. |
Countries
United States
Participant flow
Recruitment details
Subjects were contacted over the phone and, if interested, verbally consented and prescreened. Potentially eligible subjects were schedule for a visit. After signing consent during the study visit, eligibility was assessed. Approximately 438 patients were prescreened, and we have approached 140. Of those 63 were recruited and 58 randomized (5 screen failed after consent)).
Pre-assignment details
Lidocaine cream lead in. If the subject responded to lidocaine cream application after 30 minutes they were not randomized. All eligible subjects were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine Subjects randomized to this arm receive 2 mL injection of lidocaine 2% over the right and left greater occipital nerve at the baseline study visit.
All subjects then complete daily headache-related questions through a Headache Diary and other assessments for 28 days.
Lidocaine 4% Topical Application Cream \[LMX 4\]: Run-in Step: All subjects receive 32 mg (4 cm ribbon of cream) applied, bilaterally, over greater occipital nerve.
Lidocaine Hydrochloride 2 mg/mL Injectable Solution: Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment. | 29 |
| Greater Occipital Nerve (GON) Block With Saline Subjects randomized to this arm receive 2 mL injection of preservative-free normal saline over the right and left greater occipital nerve at the baseline study visit.
All subjects then complete daily headache-related questions through a Headache Diary and other assessments for 28 days.
Lidocaine 4% Topical Application Cream \[LMX 4\]: Run-in Step: All subjects receive 32 mg (4 cm ribbon of cream) applied, bilaterally, over greater occipital nerve.
Normal Saline: Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator. | 29 |
| Total | 58 |
Baseline characteristics
| Characteristic | Greater Occipital Nerve (GON) Block With Lidocaine | Greater Occipital Nerve (GON) Block With Saline | Total |
|---|---|---|---|
| Age, Continuous | 15.80 years STANDARD_DEVIATION 2 | 16.19 years STANDARD_DEVIATION 1.52 | 16.00 years STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 26 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Migraine Diagnosis Chronic migraine | 16 Participants | 15 Participants | 31 Participants |
| Migraine Diagnosis Episodic Migraine | 13 Participants | 14 Participants | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 24 Participants | 48 Participants |
| Region of Enrollment United States | 29 participants | 29 participants | 58 participants |
| Sex: Female, Male Female | 21 Participants | 26 Participants | 47 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 11 Participants |
| Sex/Gender, Customized Gender Female | 21 Participants | 23 Participants | 44 Participants |
| Sex/Gender, Customized Gender Male | 8 Participants | 3 Participants | 11 Participants |
| Sex/Gender, Customized Gender Non-binary | 0 Participants | 2 Participants | 2 Participants |
| Sex/Gender, Customized Gender Other | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 29 / 29 | 28 / 29 |
| serious Total, serious adverse events | 0 / 29 | 1 / 29 |
Outcome results
Primary
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS)
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning the worse pain imaginable. A mean change of 2-points has been shown to be clinically relevant.
Time frame: Pre-injection (*Baseline*) and 30 minutes Post-injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) | 2.3 score on a scale | Standard Error 1.9 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) | 1.1 score on a scale | Standard Error 1.9 |
p-value: 0.013t-test, 2 sided
Primary
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Ethnicity
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By ethnicity. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning the worse pain imaginable. A mean change of 2-points has been shown to be clinically relevant.
Time frame: Pre-injection (*Baseline*) and 30 minutes Post-injection
Population: Overall number is divided between the different ethnic subcategories for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Ethnicity | Hispanic | 1.3 score on a scale | Standard Deviation 1.5 |
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Ethnicity | Non-Hispanic | 2.5 score on a scale | Standard Deviation 2 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Ethnicity | Hispanic | -0.5 score on a scale | Standard Deviation 0.7 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Ethnicity | Non-Hispanic | 1.2 score on a scale | Standard Deviation 1.9 |
p-value: 0.0098ANOVA
Primary
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By race. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning the worse pain imaginable. A mean change of 2-points has been shown to be clinically relevant.
Time frame: Pre-injection (*Baseline*) and 30 minutes Post-injection
Population: Overall number is divided between the different race subcategories for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race | Asian | 0 score on a scale | Standard Deviation 0 |
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race | Black | 4 score on a scale | Standard Deviation 2.8 |
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race | White | 2.4 score on a scale | Standard Deviation 1.9 |
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race | Multiple races | 1 score on a scale | Standard Deviation 1.4 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race | Multiple races | 5 score on a scale | Standard Deviation 0 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race | Asian | 0 score on a scale | Standard Deviation 0 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race | White | 0.8 score on a scale | Standard Deviation 1.6 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race | Black | 2 score on a scale | Standard Deviation 2.6 |
p-value: 0.01ANOVA
Primary
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Sex
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By sex. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning the worse pain imaginable. A mean change of 2-points has been shown to be clinically relevant.
Time frame: Pre-injection (*Baseline*) and 30 minutes Post-injection
Population: Overall number is divided between the different sex subcategories for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Sex | Female | 2.5 score on a scale | Standard Deviation 2 |
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Sex | Male | 2 score on a scale | Standard Deviation 1.8 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Sex | Female | 1 score on a scale | Standard Deviation 1.8 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Sex | Male | 2 score on a scale | Standard Deviation 2 |
p-value: 0.0162ANOVA
Primary
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS)
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning the worse pain imaginable.
Time frame: Pre-injection and 30 minutes Post-injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) | 24.97 score on a scale | Standard Error 4.09 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) | 12.86 score on a scale | Standard Error 3.61 |
p-value: 0.031t-test, 2 sided
Primary
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Ethnicity
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By ethnicity. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning the worse pain imaginable.
Time frame: Pre-injection and 30 minutes Post-injection
Population: Overall number is divided between the different ethnic subcategories for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Ethnicity | Hispanic | 9 score on a scale | Standard Deviation 14.4 |
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Ethnicity | Non-Hispanic | 27.5 score on a scale | Standard Deviation 22.2 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Ethnicity | Hispanic | -3.5 score on a scale | Standard Deviation 4.9 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Ethnicity | Non-Hispanic | 14.5 score on a scale | Standard Deviation 19.8 |
p-value: 0.02ANOVA
Primary
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By race. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning the worse pain imaginable.
Time frame: score on a scale
Population: Overall number is divided between the different race subcategories for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race | Asian | -12 score on a scale | Standard Deviation 0 |
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race | Black | 26 score on a scale | Standard Deviation 26.9 |
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race | White | 27.2 score on a scale | Standard Deviation 21.6 |
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race | Multiple races | 14 score on a scale | Standard Deviation 21.2 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race | Multiple races | 66 score on a scale | Standard Deviation 0 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race | Asian | 3 score on a scale | Standard Deviation 0 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race | White | 10 score on a scale | Standard Deviation 17.4 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race | Black | 21.3 score on a scale | Standard Deviation 11.7 |
p-value: 0.0329ANOVA
Primary
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Sex
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By sex. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning the worse pain imaginable.
Time frame: Pre-injection and 30 minutes Post-injection
Population: Overall number is divided between the different sex subcategories for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Sex | Female | 25.5 score on a scale | Standard Deviation 23 |
| Greater Occipital Nerve (GON) Block With Lidocaine | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Sex | Male | 23.6 score on a scale | Standard Deviation 20.6 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Sex | Female | 12 score on a scale | Standard Deviation 19.6 |
| Greater Occipital Nerve (GON) Block With Saline | Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Sex | Male | 10.3 score on a scale | Standard Deviation 19 |
p-value: 0.04ANOVA
Secondary
Change From Baseline Disability
The PedMIDAS will assess changes in functional disability due to headache. The PedMIDAS is a validated 6-question scale that captures headache-related disability-across multiple domains of functioning including school, home, social, and recreational-for pediatric and adolescent aged patients over 3 months. The instrument measures the number of days in which subjects missed activities due to headache or migraine. The measure yields a total score by summing items ranging from 0 to 90 day. The higher the score the higher the disability. Change in total score (total at week 4 minus total at baseline) is reported.
Time frame: Baseline and Week 4
Population: Missing values were omitted from testing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Change From Baseline Disability | 0.036 change of score on a scale | Standard Error 8.46 |
| Greater Occipital Nerve (GON) Block With Saline | Change From Baseline Disability | -13.36 change of score on a scale | Standard Error 9.39 |
p-value: 0.294t-test, 2 sided
Secondary
Change From Baseline Disability to Day 7
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (Short Form) will assess changes in functional disability due to headache. The PROMIS Pain Interference (Short Form) measures the self-reported consequences of pain on relevant aspects of the subject's life over the past seven days. A pain item pool was developed to yield scores on a T-score scale with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more pain interference, a T-score of 60 is one standard deviation (SD) worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.
Time frame: Baseline and Day 7
Population: Missing values were omitted from testing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Change From Baseline Disability to Day 7 | 5.78 t-score | Standard Error 1.54 |
| Greater Occipital Nerve (GON) Block With Saline | Change From Baseline Disability to Day 7 | 2.11 t-score | Standard Error 1.09 |
p-value: 0.058t-test, 2 sided
Secondary
Change From Baseline Disability to Week 4
The PROMIS Pain Interference (Short Form) will assess changes in functional disability due to headache. The PROMIS Pain Interference (Short Form) measures the self-reported consequences of pain on relevant aspects of the subject's life over the past seven days. A pain item pool was developed to yield scores on a T-score scale with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.
Time frame: Baseline and Week 4
Population: Missing values were omitted from testing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Change From Baseline Disability to Week 4 | 5.05 T-score | Standard Error 1.75 |
| Greater Occipital Nerve (GON) Block With Saline | Change From Baseline Disability to Week 4 | 2.06 T-score | Standard Error 1.35 |
p-value: 0.182t-test, 2 sided
Secondary
Percentage of Subjects With Freedom From All Symptoms of Migraine
The presence or absence of photophobia, phonophobia, and nausea will be collected from subjects prospectively, via text, in an electronic headache diary.
Time frame: 24 hours Post-injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Percentage of Subjects With Freedom From All Symptoms of Migraine | 14 Participants |
| Greater Occipital Nerve (GON) Block With Saline | Percentage of Subjects With Freedom From All Symptoms of Migraine | 6 Participants |
p-value: 0.027Chi-squared
Secondary
Percentage of Subjects With Pain Freedom
The measurement involves resolution of headache pain within 30 minutes after injection and prior to any rescue medications. Data will be collected prospectively from subjects, at the study visit.
Time frame: 30 minutes Post-injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Percentage of Subjects With Pain Freedom | 5 Participants |
| Greater Occipital Nerve (GON) Block With Saline | Percentage of Subjects With Pain Freedom | 2 Participants |
p-value: 0.423Fisher Exact
Secondary
Percentage of Subjects With Pain Relief or Headache Response
The measurement involves improvement in headache from severe or moderate to none or mild within 30 minutes and before any rescue medications. Data will be collected prospectively from subjects at the study visit.
Time frame: 30 minutes Post-injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Percentage of Subjects With Pain Relief or Headache Response | 15 Participants |
| Greater Occipital Nerve (GON) Block With Saline | Percentage of Subjects With Pain Relief or Headache Response | 7 Participants |
p-value: 0.03Chi-squared
Secondary
Percentage of Subjects With Sustained Pain Freedom
The measurement involves being pain-free within 30 minutes and lasting at least 24 hours, with no use of rescue medication and no relapse or recurrence. Data will be collected prospectively from subjects, via text, in an electronic headache diary.
Time frame: 24 hours Post-injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Percentage of Subjects With Sustained Pain Freedom | 4 Participants |
| Greater Occipital Nerve (GON) Block With Saline | Percentage of Subjects With Sustained Pain Freedom | 0 Participants |
p-value: 0.112Fisher Exact
Secondary
Percentage of Subjects With Sustained Pain Relief
The measurement involves having pain-relief within 30 minutes and lasting at least 24 hours, with no use of rescue medication and no relapse or recurrence. Data will be collected prospectively from subjects, via text, in an electronic headache diary.
Time frame: 24 hours Post-injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Greater Occipital Nerve (GON) Block With Lidocaine | Percentage of Subjects With Sustained Pain Relief | 7 Participants |
| Greater Occipital Nerve (GON) Block With Saline | Percentage of Subjects With Sustained Pain Relief | 1 Participants |
p-value: 0.052Fisher Exact