Lower Back Pain Clinical Trial
Official title:
Assessment of User Comprehension of the BeActive™Brace User Guide
FDA requires that the user's guide be provided with any over-the-counter (OTC) medical device. It is beneficial to demonstrate that the user's guide for a new medical device is broadly comprehensible where the device will be provided without prescription and direct physician counseling. Therefore, a population of subjects will be tested to determine whether they can properly use the BeActive Brace device after reading the user's guide.
The primary objective of this clinical trial is to evaluate the ability of approximately 40
literate adults to understand the label instructions for deploying the Beactive(r) Brace
device as described in the user's guide, without physician direction. The primary endpoint
of this clinical trial is the successful completion of all essential tasks required for
Beactive(r) Brace deployment by a subject.
Subjects will be seated at a table facing a video camera, so Investigators and the Sponsor
may observe the subject via closed circuit television. Subjects will be given the user's
guide for the Beactive(r) Brace device. The subject will then be asked to deploy the
Beactive(r) Brace device according to their understanding following the user's guide. For
this clinical trial, deploying is defined as completing the following two tasks.
1. Applying the Beactive(r) Brace device to the knee area according to the user's guide.
2. Correctly positioning the pressure pad according to the user's guide.
If the tasks can be completed with no intervention, the subject would be judged to have a
"comprehensive" level of success. If intervention was required and helpful, and the subject
was able to complete all essential tasks, the level of success would be judged "sufficient."
The steps where intervention took place will be recorded.
Intervention will be allowed and documented if subjects have difficulty with a specific
task. The subject will raise their hand and a technician will be available for assistance.
The frequency and type of intervention will be documented.
A Study Coordinator will complete an observer questionnaire for each subject based on their
observation of each subject's ability to use the Beactive device correctly. Each subject
will complete a user questionnaire, which will confirm their understanding of the user's
guide and give them the opportunity to provide feedback and suggestions for improving the
user's guide.
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