Medical Student Research Fellowship for Summer 2009
Mentor: Jeffrey E. Janis, MD
Department: Plastic Surgery
Room number: WA4.240
Mail Code: 9132
Phone number: 214-645-3116
Project title: A Retrospective Review of the Efficacy of Botox© Treatment And Surgical Decompression as a Deactivator of Migraine Headache Trigger Sites.
Human subjects IRB approved project number (where applicable): 032008-077
Animal subjects IRB approved project number (where applicable): N/A
Project Type: Patient-based research
Brief Description of Project: The hypothesis is that these trigger points can
be deactivated by injection of Botox (giving a temporary effect) and eventual
surgical decompression, resulting in a decrease or actual elimination of migraine
headaches. The objective is to determine the efficacy of Botox© (Botulinum
Toxin Type A) when combined with surgical decompression as a deactivator of
migraine headaches (MH) after the failure of standard medication therapy. The
investigator proposes to confirm that Botox and surgical treatment together
will eliminate the recurrence of migraine headaches. Additionally, the investigator
proposes to study whether this surgical intervention will improve quality of
life and socioeconomic condition of patients with migraine headaches. A Migraine
Headache Index will be used for statistical analysis. The Migraine Headache
Index (MHI) is defined as: Number of days/month X Intensity (1-10) X Duration
(fraction of 24 hours). The Migraine Headache Index has not been validated in
the peer-reviewed literature, but we are attempting to make this study consistent
with how it has been reported thus far (Guyuron et al, 2004). The Investigator
postulates that the patients' quality of life and productivity has increased,
and time away from work has been reduced following surgical treatment of migraine
headaches, thus resulting in financial benefit for the patient and society,
on a long-term basis.
Data will be collected retrospectively from patient charts in approximately 100 patients who have received Botox injections (to determine trigger sites) for their headaches. The Botox was administered as "off-label". Both the treatment and the surgical procedure are in the patient's medical record as a documented treatment for migraine headaches, (for which they have been diagnosed), and they are required to pay for it. Data will be collected from these two populations (Botox alone and Botox followed by surgery). This data will form the basis for a future prospective study on Botox alone versus Botox followed by surgery.
Information will be collected from the Botox injections, questionnaires, surgical report and follow-up visits. The retrospective data will be collected from charts in Dr. Janis' own practice, where physical and electronic medical records will be utilized. Information gathered from the medical records will be transferred to two different Excel databases. One will contain all patient information identified only by a subject number. The other database will contain the link from the subject number to name and medical record number. Both of these databases will be stored on a password protected computer, access to which only the investigator, sub-investigators and coordinators will have access to. Information from this database will be used to do statistical analyses (including charts, graphs and tables), and will be used as the basis for a possible, future prospective study.
Expectations include the updating of a database that was started in 2008. At the conclusion of this summer, there will be sufficient information to prepare an abstract.
Previous Research Activities or Publications with Medical Students:
1 Summer Student (Summer '08)
1 Publication in process from Summer '08 - to be completed this Summer