Clinical Trial: Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Single-blind Comparison of Three Commercially Available Botulinum Neuromodulators in the Management of Facial Synkinesis

Brief Summary: The purpose of this study is to compare the effectiveness of three commercially available botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported outcome measures.

Detailed Summary:

Quality assurance:

Data is entered in to a spreadsheet as it is extracted exactly from the electronic medical record. During review of the findings, the data is again checked against the medical record to ensure accuracy. Botulinum toxin types are also verified with scanned copies of the botulinum toxin injection sheet which is filled out and scanned in to the medical record at the time of treatment.

Data dictionary:

Not necessary as limited new terminology is used and all understood among the research group. Additional terminology is clearly described for the trial participants and described in the manuscript reporting the results of the study.

Recruitment:

Patients with facial synkinesis who were appropriate candidates for botulinum toxin chemodenervation therapy were offered voluntary participation in this trial. Patients who had returned to their baseline SAQ score after a minimum of 12 weeks since their previous treatment were permitted to re-enroll in the study for subsequent treatments.

Data collection:

At 1, 2, and 4 weeks post treatment, patients were again administered the SAQ. SAQ scores were calculated for each follow up time point. The average SAQ score in each treatment group (onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA) for each week was calculated, as well as the average improvement in SAQ scores.

Data management:

Data were initially recorded and stored in the secure, password protected, electronic medical record. Data were then extracted from
Sponsor: University of Utah

Current Primary Outcome: Change in Synkinesis Assessment Questionnaire (SAQ) Scores [ Time Frame: Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks. ]

The previously validated instrument, Synkinesis Assessment Questionnaire (SAQ), was administered in order to evaluate patient-perceived severity of synkinesis. This instrument was used for each of the three treatment arms and change in scores from baseline were compared at each time point between arms.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse events [ Time Frame: Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks. ]

We hypothesized that common minor events such as bruising and swelling at injection sites would occur equally for all treatment arms, but that no major adverse treatment effects would occur for any of the treatment arms.


Original Secondary Outcome: Adverse events [ Time Frame: Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks. ]

Minor adverse effects reported during the study included redness, bruising, swelling, and fullness at the injection sites which were not felt to be significant or noted to be qualitatively different between products. No major adverse treatment effects were reported during the course of the study.


Information By: University of Utah

Dates:
Date Received: February 2, 2017
Date Started: July 2012
Date Completion:
Last Updated: February 16, 2017
Last Verified: February 2017