Chronic Daily Headache, Transformed Migraine
Conditions
Keywords
Migraine Headache, Menstrual Migraine, Vascular Headache, Temporal Lobe Seizure
Brief summary
This study will compare a local anesthetic technique that has been used to treat subjects suffering from transformed migraines (chronic migraines) versus medical management with traditional antidepressant Amitriptyline / Elavil. Subjects will be randomized into one of two treatment groups to compare the safety and efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block with 5% lidocaine gel into the nasopharynx or medical management with traditional antidepressants, Elavil, to produce a reduction in the frequency and severity of the headache. We propose that there will be a difference in the outcomes when comparing the two methods of treating transformed migraines and that one research arm will result in more patient satisfaction and greater efficacy in the treatment of subjects
Detailed description
Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks Arm two will receive Amitriptyline / Elavil daily for 30 Days
Interventions
PROCEDURESPG Block with 5% Lidocaine gel
cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
DRUGAmitriptyline
The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female age 18-90 2. Subject have formal medical diagnosis of migraine headache 3. Subjects currently require treatment for headache 4. Subjects who have received optimal medical management from migraines including triptans (Imitrex, Amerge and Relpax) 5. Subjects who have recieved optimal medical management for migraines including anticonvulsants (Depakote, Lamictal, klonopin
Exclusion criteria
1. Less than 18 years of age 2. Subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain 3. Untreated Heart Failure 4. Pregnancy 5. Individuals unwilling to comply with study procedures and follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Daily Headaches | Study Day 1 through Study Day 30 | The number of times per day that symptoms occur |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amitriptyline / Elavil Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated
SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days | 2 |
| SPG Nerve Block With Lidocaine 5% Gel Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated
SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days | 8 |
| Total | 10 |
Baseline characteristics
| Characteristic | Amitriptyline / Elavil | SPG Nerve Block With Lidocaine 5% Gel | 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 | 2 Participants | 8 Participants | 10 Participants |
| Age, Continuous | 46 years | 59 years | 56 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 8 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 1 Participants | 8 Participants | 9 Participants |
| Region of Enrollment United States | 2 participants | 8 participants | 10 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 8 |
| other Total, other adverse events | 0 / 2 | 0 / 8 |
| serious Total, serious adverse events | 0 / 2 | 0 / 8 |
Outcome results
Primary
Number of Daily Headaches
The number of times per day that symptoms occur
Time frame: Study Day 1 through Study Day 30
Population: participants from 18-82 who had failed conventional headache therapies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amitriptyline / Elavil | Number of Daily Headaches | 20.5 Number of Daily Headaches | Standard Deviation 0.5 |
| SPG Nerve Block With Lidocaine 5% Gel | Number of Daily Headaches | 13.4 Number of Daily Headaches | Standard Deviation 10.4 |
Other Pre-specified
Duration of Inactivity Associated With Headaches
The time after events that effects patient activity level
Time frame: Study Day 1 thorugh Study Day 30
Post Hoc
Length of Duration of Headache
Length of Duration of Headache
Time frame: Greater than 20 minutes