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临床试验/NCT02591953
NCT02591953终止不适用

Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
1
主要终点
Simple Shoulder Test

研究概览

简要总结

Using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables.

详细描述

Patients are diagnosed with biceps tendinitis in the outpatient clinic. After diagnosis, all the patients that meet inclusion/exclusion criteria will be offered to enroll in the study. Study will be described to the patient with regard to protocol and consent. All questions regarding the study will be answered, and it will be explicitly described that the study involvement will not change clinical care. It will be explained that investigators expect a follow up appointment at minimum at three weeks and three months. There may be further follow up requested up to 1 year from enrollment.

After collection of informed consent, the patient will be randomized to either ultrasound-guided or landmark-guided injection. The patient will complete clinical scores at the initial visit prior to the injection. After injection, the patient will have follow up scheduled for three weeks and three months. To ensure patient blinding, an ultrasound will be placed on the patient for both groups, but only active imaging with be performed for the ultrasound-guided patient group. For clinician blinding, a different clinician than the injecting clinician will perform the follow up examinations. The patient is instructed to not seek additional injections or physical therapy during the study.

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
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Pain at intertubercular groove
  • Anterior humeral pain
  • Positive Speed's Test
  • Bicep's tendinitis is primary diagnosis for patient
  • Patient agrees to follow up and consent

排除标准

  • Prior biceps surgery or injections
  • Prior SLAP or labral repair
  • Concomitant shoulder arthroplasty

研究组 & 干预措施

Ultrasound-guided Injection

Experimental

Injection performed with ultrasound-guidance

干预措施: Ultrasound-guidance (Procedure)

Ultrasound-guided Injection

Experimental

Injection performed with ultrasound-guidance

干预措施: Methylprednisolone (Drug)

Ultrasound-guided Injection

Experimental

Injection performed with ultrasound-guidance

干预措施: Lidocaine 1% (Drug)

Landmark-guided Injection

Active Comparator

Injection performed at point of maximal tenderness along biceps tendon

干预措施: Landmark-guidance (Procedure)

Landmark-guided Injection

Active Comparator

Injection performed at point of maximal tenderness along biceps tendon

干预措施: Methylprednisolone (Drug)

Landmark-guided Injection

Active Comparator

Injection performed at point of maximal tenderness along biceps tendon

干预措施: Lidocaine 1% (Drug)

结局指标

主要结局

Simple Shoulder Test

时间窗: 1 year

12 question assessment of shoulder function with yes or no answers

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

Jeremy A Alland

MD

Rush University Medical Center

研究点 (1)

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