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

NCT ID: NCT01544283

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

Brief Summary

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.

Detailed 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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patch

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Synera consists of a thin, uniform layer of a local anesthetic formulation with an integrated, oxygen-activated heating component that is intended to enhance the delivery of the local anesthetics. The drug formulation is an emulsion in which the oil phase is a eutectic mixture of lidocaine 70 mg and tetracaine 70 mg. The surface area of the entire Synera patch is approximately 50 cm2, 10 cm2 of which is active. The 40 cm2 perimeter is a medical grade adhesive. The Synera patches used in this study are the commercially available form.

Subacromial Injection

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

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: DRUG

Triamcinolone Acetonide is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. Each mL of the sterile aqueous suspension provides 40 mg of triamcinolone acetonide, with sodium chloride for isotonicity, 0.9% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and a 0.04% polysorbate 80; sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.

Interventions

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

Synera consists of a thin, uniform layer of a local anesthetic formulation with an integrated, oxygen-activated heating component that is intended to enhance the delivery of the local anesthetics. The drug formulation is an emulsion in which the oil phase is a eutectic mixture of lidocaine 70 mg and tetracaine 70 mg. The surface area of the entire Synera patch is approximately 50 cm2, 10 cm2 of which is active. The 40 cm2 perimeter is a medical grade adhesive. The Synera patches used in this study are the commercially available form.

Intervention Type: DRUG

Triamcinolone Acetonide

Triamcinolone Acetonide is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. Each mL of the sterile aqueous suspension provides 40 mg of triamcinolone acetonide, with sodium chloride for isotonicity, 0.9% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and a 0.04% polysorbate 80; sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.

Intervention Type: DRUG

Other Intervention Names

lidocaine 70 mg/tetracaine 70mg topical patch; Kenalog; Trivaris

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuvo Research Inc.

INDUSTRY

Sponsor Role: collaborator

Injury Care Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard D Radnovich, DO

Role: PRINCIPAL_INVESTIGATOR

Injury Care Medical Center

Locations

Injury Care Medical Center

Boise, Idaho, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jill L Heinz, MHS, CCRP

Role: CONTACT

jill@injurycaremedical.com

(208) 939-2100 ext. 4

Facility Contacts

Jill L Heinz, MHS, CCRP

Role: primary

jill@injurycaremedical.com

208-939-2100 ext. 4

Other Identifiers

NS001

Identifier Type: -

Identifier Source: org_study_id