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

An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Pain Associated With Myofascial Trigger Points

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01106989

Enrollment

Registered

2010-04-20

Start date

2010-06-30

Completion date

2011-01-31

Last updated

2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Syndromes

Brief summary

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

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.

Interventions

DRUGHeated lidocaine/tetracaine patch

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Pain intensity	Two weeks

Secondary

Measure	Time frame
Pain interference with activities (eg, general, normal work, sleep)	Two weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026