Has Ultrasound-guided Hydrorelease of Coracohumeral Ligamet Additional Benefit in Patients With Adhesive Capsulitis Receiving Ultrasound-guided Shoulder Hyrodilatation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Visual Analouge Scale (VAS)
研究概览
简要总结
The goal of this study is to detect if there is an additional benefit to performing ultrasound-guided hydrorelease of the coracohumeral ligament in patients with adhesive capsulitis of the shoulder receiving ultrasound-guided hydrodilatation.
详细描述
This study is organised as double-blind, randomised controlled trial. Written informed consent will be taken from all the patients participating to the study.
Inclusion Criteria
Patients between the ages of 30 and 70, who have complaints of shoulder pain and limitation in the shoulder for at least 3 months and are diagnosed with Adhesive Capsulitis by clinical examination, will be included in the study.
Exlusion Criteria
- A history of physical therapy or injections for the shoulder joint within the previous three months,
- The existence of a neurological condition or surgical history that could impair upper limb functions,
- Being a breastfeeding or pregnant woman,
- Mental illnesses and cognitive impairments that impair cooperation
- Diabetes mellitus with unregulated glucose levels
- Presenece of Cancer
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 30 and 70 who have complained of shoulder pain and limitation in the shoulder for at least 3 months and have been diagnosed with adhesive capsulitis by clinical examination will be included in the study.
排除标准
- •A history of physical therapy or injections for the shoulder joint within the previous three months,
- •The existence of a neurological condition or surgical history that could impair upper limb functions,
- •Being a breastfeeding or pregnant woman,
- •Mental illnesses and cognitive impairments that impair cooperation
- •Diabetes mellitus with unregulated glucose levels
- •Presence of Cancer
研究组 & 干预措施
Group 1
In group 1, hydrodilatation will be performed with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography. The amount of fluid given will be recorded.
干预措施: Triamcinolone Acetonide (Drug)
Group 2
The second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. The amount of fluid given will be recorded. Additionally, with ultrasonographic evaluation, 2 cc of physiological saline will be injected into the corocohumeral ligament.
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Visual Analouge Scale (VAS)
时间窗: Before and immediately after injection, 1 week,1 month and 2 moths after injection
Pain Severity
Shoulder Disability Index
时间窗: Before injection, 1 week,1 month and 2 moths after injection
Shouler Disability
Shoulder Range of Motion
时间窗: Before and immediately after injection, 1 week,1 month and 2 moths after injection
Shoulder Limitation
次要结局
未报告次要终点
研究者
Sibel süzen Özbayrak
M.D.
Haydarpasa Numune Training and Research Hospital