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| Name | Class |
|---|---|
| Nuvo Research Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patch | Experimental | 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. |
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| Subacromial Injection | Active Comparator | A single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Average pain and worst pain over past 24 hours will be measured. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Assessment of Treatment Satisfaction | 6 weeks | |
| Patient Global Impression of Change | 6 weeks | |
| Pain Interference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jill L Heinz, MHS, CCRP | Contact | (208) 939-2100 | 4 | jill@injurycaremedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Richard D Radnovich, DO | Injury Care Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Injury Care Medical Center | Recruiting | Boise | Idaho | 83713 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 8, 2013 | |
| Reset | May 22, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 8, 2013 | May 22, 2013 |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D013748 | Tetracaine |
| D057968 | Transdermal Patch |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Triamcinolone Acetonide | 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. |
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Pain interference as it relates to general activity, normal work, and sleep will be measured at each visit. |
| 6 weeks |
| Patch Site Evaluation for Erythema | site patch is applied will be assessed for erythema and patch site reactions | 6 weeks |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
| Aniline Compounds |
| D000588 | Amines |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004864 | Equipment and Supplies |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |