Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome
Phase 2
- Conditions
- Shoulder Pain
- Interventions
- Registration Number
- NCT01544283
- Lead Sponsor
- Injury Care Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patch Synera® (lidocaine 70 mg and tetracaine 70 mg) topical 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. Subacromial Injection Triamcinolone Acetonide A single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit.
- Primary Outcome Measures
Name Time Method Pain Intensity 6 weeks Average pain and worst pain over past 24 hours will be measured.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Injury Care Medical Center
🇺🇸Boise, Idaho, United States