The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Change from baseline pain score on Visual Analog Scale(VAS)
研究概览
简要总结
The goal of this interventional study is to compare the outcomes of two different injection aprroaches in patients with frozen shoulder. The main questions it aims to answer are:
- Is hydrodilatation better than intraarticular corticosteroid injection?
- Is there any prognostic factors that will help clinicians guide their decision making when choosing between these two treatments?
Participans will receive an injection(cortcosteroid and local anesthetics alone or with hydrodilatation-corticosteroid and local anesthetics plus sterile saline solution) and then they will follow a rehabilitation program.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfill the diagnostic criteria for frozen shoulder
- •Agree to participate in the study
- •Having the opportunity to follow up for at least 3 months
排除标准
- •Refusing to participate in the study
- •History of shoulder injection in the last 3 months
- •Having diabetes mellitus
- •Presence of comorbidities that contraindicate injection therapy, such as bleeding diathesis
- •Known history of allergy or anaphylaxis to drugs used in treatment
结局指标
主要结局
Change from baseline pain score on Visual Analog Scale(VAS)
时间窗: Baseline, 1 week, 1 month, 3 months
Pain scored according to VAS; between 0(no pain) to 10(worst pain)
Change in Shoulder Pain and Disability Index(SPADI) scores
时间窗: Baseline, 1 month, 3 months
Scored between 0-10 ; 0 means no pain and disability and 10 means the worst pain and disability
次要结局
- Change in Range of Movement(ROM)(Baseline, 1 week, 1 month, 3 months)
- Proprioception(Active position sense- joint position error)(Baseline, 3 months)
- Shoulder Strength(Baseline, 3 months)
- Ultrasound Parameters(Baseline, 1 month, 3 months)
- Changes in Depression Score(Baseline, 1 months, 3 months)
- Changes in Life Quality Score(Baseline, 1 month, 3 months)
- Treatment Satisfaction(3 months)
研究者
Fatmanur Yegin
Research Assistant Doctor
Istanbul University