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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01055444

Enrollment

Registered

2010-01-25

Start date

2010-03-31

Completion date

2010-09-30

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

Shoulder Impingement Syndrome

Brief summary

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

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.

Interventions

DRUGHeated lidocaine and tetracaine topical patch

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.

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

* 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/

Design outcomes

Primary

Measure	Time frame
Pain intensity	Two weeks

Secondary

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

Countries

United States

Outcome results

None listed

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