Conditions: Acute Back Strain
Keywords: FLECTORÂ® Patch acute back strain
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 123
Healthy volunteers: no

Brief summary:
Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been studied extensively in the setting of acute back strain. This study is being conducted as an initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In particular, this study is expected to provide information about the amount of improvement in back strain among subjects using the FLECTOR Patch, which may then be used to inform subsequent studies.

Detailed description:

Arms:
arm 1: One patch applied every 12 hours

Interventions: intervention 1: FLECTORÂ® Patch (diclofenac epolamine topical patch) 1.3%
Intervention descriptions: intervention 1: One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.

Protocol document: