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临床试验/NCT04949087
NCT04949087
招募中
不适用

Prospective, Double Blind, Randomized Control Trial Comparing the Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 200 人2023年3月13日

概览

阶段
不适用
干预措施
Glenohumeral Injection
疾病 / 适应症
Arthritis Shoulder
发起方
Rush University Medical Center
入组人数
200
试验地点
1
主要终点
Visual Analog Scale-Pain (VAS)
状态
招募中
最后更新
2个月前

概览

简要总结

The purpose of this study is to compare the efficacy of intra-articular corticosteroid injections versus platelet-rich plasma injections for non-operative treatment of primary glenohumeral osteoarthritis. The efficacy of intra-articular injections, outside of hyaluronic acid, for the treatment of glenohumeral OA is not known, yet these treatments are commonly used with hopes of providing patients with symptomatic relief that can hopefully delay or prevent the need for shoulder arthroplasty. This study will help elucidate the therapeutic benefit of corticosteroid and Platelet Rich Plasma (PRP) injections in this patient population.

注册库
clinicaltrials.gov
开始日期
2023年3月13日
结束日期
2028年1月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Patient ≥18y.o. of age
  • Primary glenohumeral arthritis (bone on bone or near bone on bone) that has been previously diagnosed on radiographs and clinical evaluation.
  • Baseline pain level of VAS \>4

排除标准

  • Secondary causes of arthritis (i.e. septic arthritis, rheumatoid arthritis, rotator cuff arthropathy, post-traumatic arthritis)
  • Ipsilateral shoulder surgery within 1 year
  • Any glenohumeral joint injection within 3 months
  • Allergy to lidocaine
  • Known pregnancy
  • Workers compensation case regarding shoulder

研究组 & 干预措施

Corticosteroid Injection Group

80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection

干预措施: Glenohumeral Injection

Platelet-Rich Plasma Injection Group

15cc blood draw in Arthrex Autologous Conditioned Plasma (ACP) kit and processed per manufacturer instructions Ultrasound-guided intra-articular injection of isolated PRP

干预措施: Glenohumeral Injection

结局指标

主要结局

Visual Analog Scale-Pain (VAS)

时间窗: 12 weeks

Validated patient-reported metric scale of pain: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

研究点 (1)

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