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临床试验/NCT02592629
NCT02592629终止4 期

The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2016年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
19
试验地点
1
主要终点
Change in Pain Assessment

研究概览

简要总结

The specific aim of this prospective study is to determine whether local anesthetics prior to subacromial steroid injections reduce pain and consequently if they are cost-effective in the treatment for shoulder pathology.

详细描述

Shoulder pain is a common problem that can be estimated to be prevalent in up to 15 percent of the patient population registered to general practices and is second only to back pain in patients seeking treatment for musculoskeletal issues in the primary care setting. As a common source of distress, shoulder pain contributes significantly to health care costs.

Rotator cuff disease due to impingement, tendonitis or bursitis is a frequent cause of shoulder pain and dysfunction. Initial treatment consists of a conservative approach of activity modification, oral nonsteroidal anti-inflammatory drugs (NSAIDs) and supervised physical therapy. However, if the patients' symptoms persist, subacromial injections of a local anesthetic such as lidocaine, and a corticosteroid may be indicated as a sequential treatment option.

The steroid injection itself can be a painful process, so administering a local anesthetic prior to the steroid injection is thought to mitigate pain or reduce possible discomfort during and immediately following the procedure. Though there is evidence advocating for the benefits of combining local anesthetics and corticosteroids for the treatment of subacromial pathologies, it is not conclusive whether local anesthesia significantly enhances the pain relieving effect of steroids. Should local anesthesia not have a significant impact on the patient's pain intensity, then the use of corticosteroids alone could potentially result in reduced costs in care.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 to 70 years old
  • Shoulder pain lasting at least 4 weeks
  • Inability to use arm with restriction of movement and loss of full function.
  • Able to understand study and provide voluntary, written informed consent

排除标准

  • Less than 18 or greater than 70 years old
  • Contraindications of previous injections and previous shoulder surgery
  • Unable to understand consent form (in the opinion of the PI)
  • Non-English speaking individuals
  • Medication contradictions to lidocaine, corticosteroids

研究组 & 干预措施

no topical or subcutaneous anesthetic

Active Comparator

Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine

干预措施: lidocaine (Drug)

no topical or subcutaneous anesthetic

Active Comparator

Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine

干预措施: Kenalog (Drug)

subcutaneous lidocaine

Active Comparator

Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection

干预措施: lidocaine (Drug)

subcutaneous lidocaine

Active Comparator

Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection

干预措施: Kenalog (Drug)

topical ethyl chloride

Active Comparator

Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds

干预措施: lidocaine (Drug)

topical ethyl chloride

Active Comparator

Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds

干预措施: ethyl chloride (Drug)

topical ethyl chloride

Active Comparator

Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds

干预措施: Kenalog (Drug)

结局指标

主要结局

Change in Pain Assessment

时间窗: change from baseline assessment before injection at 10 minutes post injection

Pain assessed on a visual analog scale from 1 (no pain) to 10 (worst pain imaginable). Pain score at 10 minutes post-injection is subtracted from baseline pre-injection score. Positive numbers to represent increases and negative numbers to represent decreases.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert A. Gallo

Assistant Professor of Surgery Orthopaedics

Milton S. Hershey Medical Center

研究点 (1)

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