Study Evaluating Heated Lidocaine/Tetracaine Patch in Patients With Pain Associated With Myofascial Trigger Points

Study Overview
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Brief Summary
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The purpose of this 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 myofascial trigger points.

Detailed Description
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The purpose of this pilot study is to explore the usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with myofascial trigger points. The study will consist of a 2-week, open-label treatment period followed by a 2 week follow-up period conducted at a single study site. Eligible patients must have a clinical diagnosis of pain (minimum 1-month duration) associated with up to 3 identifiable myofascial trigger points. 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 Pain Associated With Myofascial Trigger Points

Conditions
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Myofascial Pain Syndromes

Intervention / Treatment
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* Drug: Heated lidocaine/tetracaine patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 18 years of age have a clinical diagnosis of pain (minimum 1-month duration) associated with up to 3 myofascial trigger points have trigger points confined to the upper back, shoulder, and neck 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 topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit have used any injected pain medication with 28 days preceding the Screening/Baseline Visit are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.) 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 patch<br>Active | Drug: Heated lidocaine/tetracaine patch<br>* Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch directly to each trigger point identified at the Screening/Baseline Visit (up to 3 trigger points). Patches will be administered for 4 hours, 2 times per day (total of 8 hours for each trigger point per day).<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 (eg, general, normal work, sleep) |  | Two weeks |