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

Injury Care Medical Center

Status and phase: Unknown; Phase 2

Conditions: Shoulder Pain

Treatments: Drug: Triamcinolone Acetonide; Drug: Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01544283

NS001

Details and patient eligibility

About

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.

Full description

Subjects will receive either a subacromial injection at baseline or will be issued Synera patches to use daily for 2 weeks and then PRN for an additional 2 weeks.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Patch

Experimental group

Description:

Patch will be applied directly to the lateral tip of the affected shoulder, at the site of maximal tenderness. Subjects will apply a single patch at home approximately every 12 hours (e.g., morning and evening patch applications) for 14 days. Subjects will remove each patch after 4 hours. Subjects will have the option of applying the Synera patch as needed for an additional 2 week period (weeks 2-4) if they feel their shoulder impingement pain is severe enough to warrant treatment. Patches will be applied every 12 hours for up to 4 hours as needed during this period.

Treatment:

Drug: Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch

Subacromial Injection

Active Comparator group

Description:

A single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit.

Treatment:

Drug: Triamcinolone Acetonide