Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch (Drug)
Subacromial Injection
A single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit.
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Pain Intensity
时间窗: 6 weeks
Average pain and worst pain over past 24 hours will be measured.
次要结局
- Patient Global Impression of Change(6 weeks)
- Patient Global Assessment of Treatment Satisfaction(6 weeks)
- Pain Interference(6 weeks)
- Patch Site Evaluation for Erythema(6 weeks)