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临床试验/NCT02867904
NCT02867904终止4 期

Efficacy of Intra-operative Subacromial Corticosteroid Injections on Surgical Outcomes After Arthroscopic Shoulder Surgery

Peter Chang1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
12
试验地点
1
主要终点
Disabilities of the Arm, Shoulder, and Hand Survey (DASH)

研究概览

简要总结

The purpose of this study is to assess the efficacy of intra-operative subacromial corticosteroid injections in patients undergoing arthroscopic shoulder surgery on quality of life scores and activity level when compared to a control group.

详细描述

This study is designed to assess whether a subacromial injection of corticosteroids at the time of arthroscopic shoulder surgery influences quality of life scores and activity level when compared to a control group. The hypothesis is that intra-operative subacromial corticosteroid injection after arthroscopic subacromial decompression surgery will provide a more rapid improvement in quality of life scores and activity levels in the post-operative period compared with controls. The study will be a placebo-controlled, double-blind prospective study. All patients necessitating arthroscopic shoulder surgery presenting to Dr. Keith Baumgarten's clinics are eligible for participation. If the patient meets the inclusion criteria, then informed consent will be obtained for participation in this study. Each patient will undergo a standard shoulder exam to assess active range of motion and complete demographics and pre-operative patient determined outcomes surveys (1. Disabilities of the Arm, Shoulder, and Hand (DASH) 2. Simple Assessment Numeric Evaluation (SANE) 3. Western Ontario Rotator Cuff (WORC)) and the Marx shoulder activity level survey (MARX). Patients will then undergo arthroscopic shoulder surgery. After arthroscopic surgery the experimental group will undergo a subacromial corticosteroid injection + marcaine while the control group will undergo a subacromial marcaine injection. Outcomes will be assessed using the same quality of life surveys and an activity level survey at post-operative visits at the time intervals: 2 weeks and 3 months and by U.S. mail at 5 months and 1 year. Active range of motion will be assessed at post-operative visits: 2 weeks, 6 weeks, and 3 months. Subjects that meet criteria to undergo arthroscopic shoulder surgery will be provided informed consent to receiving either a subacromial corticosteroid injection or placebo injection at the end of surgery. Patients will be expected to complete all pre- and post-operative quality of life surveys and activity level surveys. It will take less than 20 minutes to complete all listed surveys at each pre- and post-operative visit. Active range of motion will be assessed at each post-operative visit and subjects will be expected to take part in this physical examination as well. The duration of subject participation is 1 year from the date of initial surgery.

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years-old or older
  • Male patients
  • Female patients
  • Patients able to speak and understand written English
  • Patients presenting to the orthopedic institute clinic with shoulder pain and necessitating the procedure of arthroscopic shoulder surgery
  • Specific arthroscopic procedures include: intra-articular debridement, decompression, acromioplasty, and acromioclavicular joint resection

排除标准

  • Patients undergoing arthroscopic shoulder surgery that includes other interventions (i.e. rotator cuff repair; labral repair, etc)
  • Patients with adhesive capsulitis
  • Patients with significant cervical spine symptoms and/or pathology
  • Patients having a history of receiving chronic pain treatment
  • Patients who are currently pregnant or who become pregnant before surgery
  • Patients who cannot speak or understand written english
  • Patients who are under the age of 18 years of age
  • As per exclusionary criteria if a subject is pregnant they will not be eligible for participation.

研究组 & 干预措施

Group A

Placebo Comparator

After arthroscopic surgery the control group (Group A) will undergo a subacromial marcaine injection (standard of care).

干预措施: Marcaine (4ml 0.5%, injection) (Drug)

Group B

Experimental

After arthroscopic surgery the experimental group (Group B) will undergo a subacromial corticosteroid injection+marcaine.

干预措施: Methylprednisolone (40 mg depomedrol, 1ml, injection) (Drug)

Group B

Experimental

After arthroscopic surgery the experimental group (Group B) will undergo a subacromial corticosteroid injection+marcaine.

干预措施: Marcaine (4ml 0.5%, injection) (Drug)

结局指标

主要结局

Disabilities of the Arm, Shoulder, and Hand Survey (DASH)

时间窗: 1 year

次要结局

  • Active Range of Motion of Shoulder(Pre-operatively and Post-operatively at 2 weeks, 6 weeks, and 3 months)
  • Simple Assessment Numeric Evaluation (SANE)(1 year)
  • Western Ontario Rotator Cuff Survey (WORC)(1 year)
  • Marx Shoulder Activity Level Survey (MARX)(1 year)

研究者

发起方
Peter Chang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Peter Chang

Medical Student Researcher

University of South Dakota

研究点 (1)

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