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A growing body of literature on the cosmetic use of OnabotulinumtoxinA has suggested that the use of preserved saline exerts a local anesthetic effect, and reduces the procedure discomfort when used in reconstitution in lieu of preservative-free saline. However, this has never been studied in chronic migraine.
While reducing discomfort is a desirable target in all procedures, it has a special importance in the use of OnabotulinumtoxinA for chronic migraine due to the numerous injection locations each session (31 sites) and the ubiquity of scalp tenderness in this population. In addition, the pain during procedure is a known migraine trigger for many of these patients.
We hypothesize that preserved saline (known as bacteriostatic saline) produces lower procedure-related discomfort when used as a dissolving solution for OnabotulinumtoxinA in individuals with chronic migraine as opposed to using preservative-free saline.
In addition, we hypothesize that reduction of procedure-relate pain during the injections will also result in reduced migraine/headache attacks in the week immediately following the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox in preservative-free saline | No Intervention | OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative-free saline, as recommended by the manufacturer. 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites) | |
| Botox in preserved saline | Active Comparator | OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative saline (i.e. bacteriostatic saline). 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preserved saline in reconstitution of Botox | Drug | The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine. |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Pain Scale | Difference in verbal pain scale (0 to 10, 0 indicates no pain, and 10 indicates most severe pain) | Immediately after intervention, an average of 2 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Headache-day Frequency | Difference in headache-days in the first week following the procedure | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
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Subjects were recruited from the headache clinic of SUNY Upstate Medical University which is a tertiary care center in central New York. Two of the authors performed the randomization through a simulated "coin flipper" website (www.random.org). Following the randomization, same authors prepared the syringes. Two different authors performed the injections.
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| ID | Title | Description |
|---|---|---|
| FG000 | Botox in Preservative-free Saline | OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative-free saline, as recommended by the manufacturer. 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites) |
| FG001 | Botox in Preserved Saline | OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative saline (i.e. bacteriostatic saline). 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites). Preserved saline in reconstitution of Botox: The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botox in Preservative-free Saline | OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative-free saline, as recommended by the manufacturer. 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Verbal Pain Scale | Difference in verbal pain scale (0 to 10, 0 indicates no pain, and 10 indicates most severe pain) | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately after intervention, an average of 2 minutes |
|
up to 7 days
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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 | Botox in Preservative-free Saline | OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative-free saline, as recommended by the manufacturer. 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Profressor | SUNY Upstate medical University | 3154644243 | zidan@upstate.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 | Nov 13, 2019 | May 8, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| BG001 |
| Botox in Preserved Saline |
OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative saline (i.e. bacteriostatic saline). 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites). Preserved saline in reconstitution of Botox: The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Headache-day Frequency | Difference in headache-days in the first week following the procedure | Posted | Mean | Standard Deviation | days | 1 week |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Botox in Preserved Saline | OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative saline (i.e. bacteriostatic saline). 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites). Preserved saline in reconstitution of Botox: The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |