Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome

Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot

Objective:

This purpose of this pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with shoulder impingement syndrome.

Subjects will receive either a subacromial injection at baseline or will be issued Synera patches to use daily for 2 weeks and then PRN for an additional 2 weeks.

Inclusion Criteria:

• be at least 18 years of age.
• have pain associated with shoulder impingement syndrome in a single shoulder (minimum 2-week duration).
• have tenderness at the attachment site of the rotator cuff tendons.
• have positive Hawkin's and Neer's signs.
• report an average pain intensity score of 4 (on an 11-point scale) over the past 24 hours at the Screening/Baseline visit.

Exclusion Criteria:

• have used any topically applied pain medication on the target treatment area within 14 days preceding Study Day 1, such as non-steroidal anti-inflammatory drugs (NSAIDs), menthol, methyl salicylate, local anesthetics (including Lidoderm®), or steroids.
• have used any injected medication within 60 days preceding Study Day 1, such as local anesthetic (lidocaine) or steroids.
• have a clinically significant illness within 14 days of Screening/Day 1 that, in the opinion of the investigator, would preclude the subject from participating in the study.
• are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)
• have a history of and/or past diagnosis of severe hepatic disease.
• have participated in a clinical trial of an unapproved drug within 30 days prior to screening.
• are pregnant, breastfeeding, or a female of childbearing potential and not practicing an acceptable method of birth control.
• are unable or unwilling, in the opinion of the investigators, to comply with all study procedures and cooperate fully with research staff.
• have filed a disability claim or are currently receiving disability payments for shoulder impingement syndrome.