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no patients during covid pandemic
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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
Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks
Arm two will receive Amitriptyline / Elavil daily for 30 Days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPG Nerve Block with Lidocaine 5% gel | Active Comparator | 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 |
|
| Amitriptyline / Elavil | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPG Block with 5% Lidocaine gel | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Daily Headaches | The number of times per day that symptoms occur | Study Day 1 through Study Day 30 |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of Inactivity Associated With Headaches | The time after events that effects patient activity level | Study Day 1 thorugh Study Day 30 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ | New Brunswick | New Jersey | 08901 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Daily Headaches | The number of times per day that symptoms occur | participants from 18-82 who had failed conventional headache therapies | Posted | Mean | Standard Deviation | Number of Daily Headaches | Study Day 1 through Study Day 30 |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| william grubb md | Rutgers/RWJMS | 7322357827 | grubbwr@rwjms.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2021 | Aug 31, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2021 | Oct 18, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D008881 | Migraine Disorders |
| D014653 | Vascular Headaches |
| D004833 | Epilepsy, Temporal Lobe |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D051270 | Headache Disorders, Primary |
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| ID | Term |
|---|---|
| D000639 | Amitriptyline |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Amitriptyline | Drug | The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days |
|
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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 |
|
|
| Other Pre-specified | Duration of Inactivity Associated With Headaches | The time after events that effects patient activity level | Not Posted | Study Day 1 thorugh Study Day 30 | Participants |
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
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| D002561 | Cerebrovascular Disorders |
| D051271 | Headache Disorders, Secondary |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| D000073376 | Epileptic Syndromes |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |