Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary goal of this study is to document the return of shoulder motion and resolution of adhesive capsulitis after intra-articular versus subacromial steroid injections versus anesthetic injections in combination with physical therapy.
研究概览
简要总结
The primary objective is to compare the clinical outcomes of patients with a clinical diagnosis of Adhesive Capsulitis who receive intra-articular versus subacromial steroid injections.
The secondary objective is to verify that steroid injections in combination with physical therapy lead to more favorable outcomes than local anesthetic injections in combination with physical therapy.
详细描述
Current treatment for Adhesive Capsulitis involves physical therapy. Steroid injections have not been shown to be as effective alone without the physical therapy. However, there are multiple studies that document the benefit of adding a steroid injection to the physical therapy. After a review of the literature, there are studies that compare different dosages of intra-articular steroid injections,value and site of the injections, and accuracy of clinical injections. There are currently no studies that compare the results after intra-articular versus subacromial injections in combination with physical therapy. This study would help us determine if location of the injection is a major factor in regaining motion. If it is significantly important to be intra-articular with the steroid, than it may be important to send patients for fluoroscopic guided injections routinely rather than risk the chance of not being within the joint.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet clinical diagnosis of primary Adhesive Capsulitis
- •Restriction in abduction to less than 130 degrees
- •50% reduction in external rotation as compared with the contralateral side
- •An intact rotator cuff
- •Between 18-75 years of age
排除标准
- •Previous shoulder capsular surgery
- •History of steroid injection(s) into affected shoulder
- •Inability to provide informed consent
- •Iodinated contrast dye allergy
- •Allergy to lidocaine
- •Other suspected shoulder pathology (i.e., tumor, rotator cuff rupture. infection, arthritis)
- •Known bleeding diathesis
- •Cervical spine pathology
- •History of trauma to the shoulder
- •Pregnancy
研究组 & 干预措施
Group 1
The patient receives intra-articular steroid and local anesthetic injection under fluoroscopy.
干预措施: Lidocaine + Kenalog (Drug)
Group 2
The patient receives subacromial steroid and local anesthetic injection under fluoroscopy.
干预措施: Lidocaine + Kenalog (Drug)
Group 3
The patient receives intra-articular local anesthetic injection under fluoroscopy.
干预措施: Lidocaine (Drug)
Group 4
The patient receives subacromial local anesthetic injection under fluoroscopy.
干预措施: Lidocaine (Drug)
结局指标
主要结局
The primary goal of this study is to document the return of shoulder motion and resolution of adhesive capsulitis after intra-articular versus subacromial steroid injections versus anesthetic injections in combination with physical therapy.
时间窗: 6-8 months
次要结局
未报告次要终点
研究者
April Armstrong
Associate Professor
Milton S. Hershey Medical Center