Shoulder Pain
Conditions
Keywords
Shoulder Pain, Shoulder Impingement Syndrome
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.
Interventions
DRUGSynera® (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.
DRUGTriamcinolone 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.
Sponsors
Nuvo Research Inc.
Injury Care Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 6 weeks | Average pain and worst pain over past 24 hours will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment of Treatment Satisfaction | 6 weeks | — |
| Patient Global Impression of Change | 6 weeks | — |
| Pain Interference | 6 weeks | Pain interference as it relates to general activity, normal work, and sleep will be measured at each visit. |
| Patch Site Evaluation for Erythema | 6 weeks | site patch is applied will be assessed for erythema and patch site reactions |
Countries
United States
Contacts
Primary ContactJill L Heinz, MHS, CCRP
Outcome results
None listed