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临床试验/CTRI/2025/09/094553
CTRI/2025/09/094553尚未招募不适用

Development and Validation of Clinical Diagnostic Tests for Stage I and II Idiopathic Frozen Shoulder Using MRI Features of the Rotator Interval

Srinivas college and research centre1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
58
试验地点
1
主要终点
Validity and diagnostic accuracy of coroid pain test scale, DTPER, ERPT WITH MRI

研究概览

简要总结

Idiopathic frozen shoulder (IFS) is a common musculoskeletal condition characterized by pain and restricted shoulder motion. Accurate diagnosis in the early stages remains difficult due to the absence of validated, anatomically grounded clinical tests. Existing bedside assessments such as the Coracoid Pain Test (CPT), Direct Tenderness Palpation of External Rotation (DTPER), and External Rotation Positional Test (ERPT) show promise but have not been validated against imaging.

Magnetic resonance imaging (MRI) is capable of detecting key rotator interval (RI) changes in IFS, including coracohumeral ligament thickening and anterior capsule fibrosis, but its cost and limited accessibility make it impractical for routine screening.

This cross-sectional diagnostic study aims to develop and validate the Coracoid Pain Test Scale (CPTS) and evaluate its reliability and diagnostic accuracy, along with DTPER and ERPT, using MRI findings of the rotator interval as the anatomical reference standard. Adult participants with Stage I and II IFS will be assessed, with inclusion and exclusion criteria applied to minimize confounding conditions. The primary outcome will be the diagnostic accuracy of CPTS compared with MRI. Findings are expected to provide clinicians with a standardized, reliable, and cost-effective tool for early diagnosis of frozen shoulder, reducing unnecessary imaging referrals and supporting timely, evidence-based management.

研究设计

研究类型
Observational

入排标准

年龄范围
35.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age between 35 to 70 years.
  • Clinical diagnosis of Stage I or Stage II idiopathic frozen shoulder.
  • Shoulder pain duration more than or equal to 1 month.
  • External rotation loss more than or equal to 25 degrees compared to the opposite side.
  • Willing to undergo MRI and provide written informed consent.

排除标准

  • History of post traumatic or post surgical shoulder stiffness.
  • Presence of full thickness rotator cuff tear.
  • Presence of moderate to severe glenohumeral osteoarthritis.
  • Systemic inflammatory diseases such as rheumatoid arthritis or lupus.
  • Contraindications to MRI such as pacemaker, metal implants, or claustrophobia.
  • Received steroid injection within the last three months.
  • Bilateral frozen shoulder.
  • Normal MRI findings despite clinical features of frozen shoulder.

结局指标

主要结局

Validity and diagnostic accuracy of coroid pain test scale, DTPER, ERPT WITH MRI

时间窗: At baseline as it is one time study

次要结局

  • Inter-rater & intra-rater reliability of the clinical tests (measured using kappa/ICC values).(Timepoint Within 1 week of initial testing.)

研究者

发起方
Srinivas college and research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Akshitha K R

srinivas university

研究点 (1)

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