跳至主要内容
临床试验/NCT04366570
NCT04366570Unknown不适用

Neck-shoulder Pain - is it Possible to Use Commonly Used Provocative Tests and Functional Scores for Evaluation? Large Scale Prospective Cohort Study

I.M. Sechenov First Moscow State Medical University0 个研究点目标入组 1,402 人开始时间: 2013年1月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,402
主要终点
correlation between shoulder girdle injury (and its treatment) and NSP in patients without previous pathology

研究概览

简要总结

The aim of this study is to determine and statistically justify the correlation between shoulder girdle injuries and the development of neck-shoulder pain syndrome.

The study enrolled 1402 patients with hospital-treated shoulder girdle injuries (with consequences of upper limb trauma). Detailed protocol and questionnaire for clinical examination after discharge from the hospital were conducted. The prevalence of neck-shoulder pain among patients was calculated. The diagnostic value (sensitivity and specificity) of tests used in the study was assessed.

详细描述

The study's objective is to investigate and statistically justify the correlation between shoulder girdle injury (and its treatment) and NSP in patients without previous pathology.

Methods. Study design. This study was prospective, cohort, single center. A total of 1402 consecutive patients (with consequences of upper limb trauma) - 1014 males (72,3%) and 388 females (27,7%) aged 18-60 years (mean 40,5 ± 3,8 years) referred for shoulder examinations in our musculoskeletal clinic since 2013 were included.

The study was approved by the institutional Ethical Committee. Patient inclusion criteria: male and female individuals aged 18 to 60 years old; the shoulder girdle injury at least 1 year ago plus surgical or conservative injury-related treatment; patients able and willing to actively participate to the necessary rehabilitation protocol and clinical and radiological procedures; signed an ethics committee reviewed and approved informed consent form.

Patient exclusion criteria: previous spine injuries and diseases; combined distal and midshaft humerus fractures; patients unwilling to participate to the study.

Assessment methods. The patients were divided into 3 study groups according to localization of the injury.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • male and female individuals aged 18 to 60 years old; the shoulder girdle injury at least 1 year ago plus surgical or conservative injury-related treatment; patients able and willing to actively participate to the necessary rehabilitation protocol and clinical and radiological procedures; signed an ethics committee reviewed and approved informed consent form.

排除标准

  • previous spine injuries and diseases; combined distal and midshaft humerus fractures; patients unwilling to participate to the study

结局指标

主要结局

correlation between shoulder girdle injury (and its treatment) and NSP in patients without previous pathology

时间窗: 1-2 years after injury

To carry out these tasks, it seems important to define and statistically substantiate the connection between shoulder injuries and the development of NSP in patients without vertebrogenous pathology. Then to analyze the diagnostic value (sensitivity and specificity) of the most used and well known cervical and shoulder clinical tests and stress tests. Based on the data and the statistical distribution of results, identify the most used clinical types of NSP, and create a working classification of it.

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

Lipina Marina Mikhailovna

associate professor

I.M. Sechenov First Moscow State Medical University

相似试验

Neck-shoulder Pain. Large Scale Prospective Cohort... | 临床试验