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临床试验/CTRI/2024/02/063360
CTRI/2024/02/063360已完成不适用

Functional outcomes following different doses of USG guided intra-articular steroid injection in patients with idiopathic frozen shoulder: A prospective study

DR RONAK MOHANTY1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Clinical outcomes based on NRS and SPADI scores at different points of time after the intra-articular shoulder injection.

研究概览

简要总结

After obtaining clearances from IEC & CTRI, all patients who satisfy the inclusion criteria for intra articular steroid injection for primary frozen shoulder(in freezing stage) will be taken into study. Two established standards of care are practiced in our tertiary health centre. One orthopaedic surgeon practices 80mg USG guided triamcinolone as his standard of care and second orthopaedic surgeon practices 40 mg as his standard of care. Prior to the injection, NRS and SPADI scores will be taken and the patients will followed in an interval of 48 hrs, 10 days, 1 month, 3 months and 6 months. At the end, the collected data will be evaluated for longevity as well as symptom relief. Confidentiality of each patient will be maintained.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients clinico-radiologically diagnosed as idiopathic frozen shoulder (Non traumatic shoulder stiffness for more than six weeks).

排除标准

  • Evidence of rotator cuff tear on USG, detectable shoulder pathology in shoulder radiograph, secondary shoulder stiffness.
  • History of ipsilateral shoulder trauma for e.g. fracture or dislocation, patients unfit for injection for e.g. local skin infection and uncontrolled diabetes, first time diagnosed diabetic of HbA1c of more than 7.5%.

结局指标

主要结局

Clinical outcomes based on NRS and SPADI scores at different points of time after the intra-articular shoulder injection.

时间窗: Clinical outcomes based on NRS and SPADI scores at different points of time after the intra-articular shoulder injection. | Before shoulder injection, 48 hours post injection, 10 days post injection, 1 month post injection, 3 months post injection, 6 months post injection.

次要结局

  • Longevity of the effect post intra-articular shoulder injection through SPADI and NRS scores(48 hours, 10 days, 1 month, 3 months and months)

研究者

发起方
DR RONAK MOHANTY
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr RONAK MOHANTY

Kasturba Hospital, MAHE, Manipal

研究点 (1)

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