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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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 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.
Injury Care Medical Center
Boise, Idaho, United States
RECRUITINGPain Intensity
Average pain and worst pain over past 24 hours will be measured.
Time frame: 6 weeks
Patient Global Assessment of Treatment Satisfaction
Time frame: 6 weeks
Patient Global Impression of Change
Time frame: 6 weeks
Pain Interference
Pain interference as it relates to general activity, normal work, and sleep will be measured at each visit.
Time frame: 6 weeks
Patch Site Evaluation for Erythema
site patch is applied will be assessed for erythema and patch site reactions
Time frame: 6 weeks
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