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临床试验/NCT06129006
NCT06129006尚未招募不适用

Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder

Assiut University0 个研究点目标入组 50 人开始时间: 2023年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
The Shoulder Pain and Disability Index (SPADI)

研究概览

简要总结

To compare ultrasound-guided shoulder anterior capsular infiltration plus hydrodilatation with a steroid versus hyalase in patients with frozen shoulders

详细描述

Frozen shoulder (FS) is a self-limiting pathology of the shoulder joint causing restriction in both the active and passive range of movements associated with pain (Konarski et al., 2020).

A frozen shoulder is a common condition causing severe pain and a reduced range of motion in the shoulder. It can result in detrimental effects on quality of life and the ability to perform activities of daily living (ADLs). It affects 2% to 5% of the global population and is more common in diabetic patients. There are a variety of treatment options available for patients with frozen shoulders as part of the management ladder of interventions. FS may persist for more than three years or may never resolve (Sam et al., 2023).

Conservative management includes physiotherapy, NSAIDs, Hydrodilatation (HD), intra-articular steroids, manipulation under anesthesia, and arthroscopic, or open capsular release. Distension of the shoulder capsule with normal saline and steroid infusion has been suggested to benefit by changing the biochemical properties of the capsule in FS (Cho et al., 2019).

Hydrodilatation of the shoulder joint capsule was a novel treatment to alleviate the pain of the affected shoulder. The procedure may be given with or without an adjuvant corticosteroid. Hydrodilatation, using saline and a corticosteroid, was superior in short-term pain reduction and range of motion improvement compared to management using only physiotherapy and corticosteroid injection in patients treated for frozen shoulder (Prasetia et al., 2022).

The proposed hypothesis regarding the mechanism of action in hydrodilatation and pain reduction in patients with frozen shoulder was associated with synovitis and fibrosis removal. Previous studies also noted better pain reduction in patients receiving hydrodilatation with adjuvant corticosteroid than only corticosteroid injection (Albana et al., 2022).

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

入选标准

  • 1- Patients diagnosed with unilateral frozen shoulder. 2- Diagnosis of frozen shoulder will be based on clinical examination (restriction of passive external rotation in the affected shoulder > 50% compared to the opposite side), in the presence of normal plain radiographs (anteroposterior and axillary projections other than calcific tendinopathy).
  • 3- Patients with symptoms for more than three months but less than one year which has not improved with medications and physiotherapy.
  • 4- aged 30 to 70 years old

排除标准

  • History of trauma to the shoulder.
  • History of fracture or dislocation around the shoulder.
  • Inflammatory arthritis
  • coagulation disorders
  • History of previous injections within three months.
  • Cervical radiculopathy.

结局指标

主要结局

The Shoulder Pain and Disability Index (SPADI)

时间窗: baseline and 3 weeks, 3 months, and 12 months after the intervention

The Shoulder Pain and Disability Index (SPADI) will be used to evaluate pain and disability at baseline and 3 weeks, 3 months, and 12 months after the intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Yehia Mohamed

principal investigator

Assiut University

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