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临床试验/NCT05549674
NCT05549674已完成不适用

The Copenhagen Cohort of Patients With Shoulder Pain: A Study Investigating Subacromial Impingement and Related Clinical Entities

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
218
试验地点
1
主要终点
Shoulder Pain and Disability Index (SPADI) 3 months after treatment is commenced.

研究概览

简要总结

The COPAIN study is comprised of three studies; a cross-sectional study (study 1), a prospective study (study 2) and a randomized controlled trial (study 3). Study 3 is described in detail in a separate protocol (the SELECT trial protocol) and is not described in further detail here.

详细描述

  1. Study design

Patients presenting with subacromial impingement syndrome (SIS) are subcategorized into clinical entities (section 6), including the entity 'isolated SI'. The distribution of patients within the different clinical entities is explored in study 1. Patients presenting with an entity other than isolated SI are treated in accordance with the preference of the treating shoulder surgeon. There is no formal follow-up of these patients within this project.

Patients with isolated SI are prescribed at least three months of structured physiotherapy, and the correlation between the treatment outcome and individual pathophysiological factors (section 4) are investigated (study 2). Patients who does not benefit satisfactorily from at least 3 months of structured physiotherapy and presents with prolonged symptoms (at least 6 months) are offered to participate in a randomized controlled trial investigating the difference in treatment outcome from glenohumeral arthroscopy and ASD compared to glenohumeral arthroscopy alone (study 3). All patients are diagnosed and treated by orthopedic shoulder surgeons. 2. Research questions and objectives

Study 1 1.31 Research question 1: Do patients with SIS constitute a heterogeneous group?

Objective 1:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Shoulder Pain and Disability Index (SPADI) 3 months after treatment is commenced.

时间窗: 3 months

SPADI is a patient-reported outcome measure designed to evaluate shoulder pain and disability. It ranges from 0 (best) to 100 (worst). It has 5 pain items and 8 disability items. The Danish version of SPADI has been found to have good reliability.

次要结局

  • EQ-5D-3L(Baseline, 3, 6 and 12 months)
  • Active shoulder abduction range of motion (AROM)(Baseline, 3, 6 and 12 months)
  • Oxford Shoulder Score(Baseline, 3, 6 and 12 months)

研究者

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

Adam Witten

Medical Doctor, PhD student

Hvidovre University Hospital

研究点 (1)

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