Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome

Study Overview
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Brief Summary
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The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome

Detailed Description
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The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.

Official Title
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An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome

Conditions
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Shoulder Impingement Syndrome

Intervention / Treatment
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* Drug: Heated lidocaine and tetracaine topical patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain associated with shoulder impingement syndrome in a single shoulder Have tenderness at the attachment site of the rotator cuff tendons in the affected shoulder Have positive Hawkins and Neers signs Exclusion Criteria: Have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline visit Have used any injected pain medication within 14 days preceding the Screening/Baseline visit Are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.) Have a history of and/or past diagnosis of severe hepatic disease Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heated lidocaine/tetracaine topical patch<br>Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours. | Drug: Heated lidocaine and tetracaine topical patch<br>* Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours.<br>* Other names: Synera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity |  | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain interference with activities (general, normal work, and sleep) |  | Two weeks |