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

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Injury Care Medical Center
• Collaborator: Nuvo Research Inc.
• Treatments: Lidocaine; Tetracaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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.