Recruiting
Phase 2

Pain Patch vs. Injections

Sponsor:

Injury Care Medical Center

Code:

NCT01544283

Conditions

Shoulder Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Triamcinolone Acetonide

Study Details

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.

Conditions

Shoulder Pain

Study ID

NCT01544283

Start date

Mar, 2012

Status verified date

Mar, 2012

Completion date

Mar, 2014

Anticipated

Primary completion date

Jan, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Subacromial Injection

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

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.

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.

Primary outcome measure

  • Pain Intensity [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Jill L Heinz, MHS, CCRP

(208) 939-2100jill@injurycaremedical.com

Locations

Injury Care Medical Center

Recruiting

Boise, Idaho, United States, 83713

Contacts

Jill L Heinz, MHS, CCRP

208-939-2100jill@injurycaremedical.com

Principal Investigator:

Richard D Radnovich, DO

More Information

Sponsor

Injury Care Medical Center

Last update posted

Mar 6, 2012

Last verified

Mar, 2012

Keywords

  • Shoulder Pain
  • Shoulder Impingement Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Injury Care Medical Center on 2012-03-06.