Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome
|ClinicalTrials.gov Identifier: NCT01544283|
Recruitment Status : Unknown
Verified March 2012 by Injury Care Medical Center.
Recruitment status was: Recruiting
First Posted : March 5, 2012
Last Update Posted : March 6, 2012
This purpose of this pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with shoulder impingement syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain||Drug: Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch Drug: Triamcinolone Acetonide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||March 2014|
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.
Drug: 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.
Other Name: lidocaine 70 mg/tetracaine 70mg topical patch
Active Comparator: Subacromial Injection
A single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit.
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.
- Pain Intensity [ Time Frame: 6 weeks ]Average pain and worst pain over past 24 hours will be measured.
- Patient Global Assessment of Treatment Satisfaction [ Time Frame: 6 weeks ]
- Patient Global Impression of Change [ Time Frame: 6 weeks ]
- Pain Interference [ Time Frame: 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 [ Time Frame: 6 weeks ]site patch is applied will be assessed for erythema and patch site reactions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544283
|Contact: Jill L Heinz, MHS, CCRP||(208) 939-2100 ext firstname.lastname@example.org|
|United States, Idaho|
|Injury Care Medical Center||Recruiting|
|Boise, Idaho, United States, 83713|
|Contact: Jill L Heinz, MHS, CCRP 208-939-2100 ext 4 email@example.com|
|Principal Investigator: Richard D Radnovich, DO|
|Principal Investigator:||Richard D Radnovich, DO||Injury Care Medical Center|