Chronic Migraine, Headache
Conditions
Keywords
Migraine, Onabotulinumtoxin A, Botox, Reconstitution, Saline
Brief summary
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.
Interventions
DRUGPreserved 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.
Sponsors
State University of New York - Upstate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients with diagnosis of chronic migraine receiving FDA-approved treatment with OnabotulinumtoxinA injection as per standard protocol. Standard protocol consists of 31 injection sites, with total dose ranging from 155 u to 195u.
Exclusion criteria
* Subjects whom OnabotulinumtoxinA injections deviate from standard protocol for any reason, such as head/neck infection, head deformity, recent surgery…etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Pain Scale | Immediately after intervention, an average of 2 minutes | Difference in verbal pain scale (0 to 10, 0 indicates no pain, and 10 indicates most severe pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache-day Frequency | 1 week | Difference in headache-days in the first week following the procedure |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 39 |
| 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. | 29 |
| Total | 68 |
Baseline characteristics
| Characteristic | Botox in Preserved Saline | Total | Botox in Preservative-free Saline |
|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 14.3 | 43 years STANDARD_DEVIATION 14 | 42.5 years STANDARD_DEVIATION 13.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 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 | 29 Participants | 68 Participants | 39 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 57 Participants | 30 Participants |
| Sex: Female, Male Male | 2 Participants | 11 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 29 |
| other Total, other adverse events | 0 / 39 | 0 / 29 |
| serious Total, serious adverse events | 0 / 39 | 0 / 29 |
Outcome results
Primary
Verbal Pain Scale
Difference in verbal pain scale (0 to 10, 0 indicates no pain, and 10 indicates most severe pain)
Time frame: Immediately after intervention, an average of 2 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Botox in Preservative-free Saline | Verbal Pain Scale | 5.3 score on a scale |
| Botox in Preserved Saline | Verbal Pain Scale | 3.3 score on a scale |
Secondary
Headache-day Frequency
Difference in headache-days in the first week following the procedure
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox in Preservative-free Saline | Headache-day Frequency | 4.6 days | Standard Deviation 2.3 |
| Botox in Preserved Saline | Headache-day Frequency | 4.1 days | Standard Deviation 1.7 |