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临床试验/NCT07124689
NCT07124689已完成不适用

Relationship Between Central Sensitization Levels and Treatment Outcomes in Patients Diagnosed With Frozen Shoulder and Undergoing Intra-Articular Injection

Sultan 1. Murat State Hospital1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2025年8月9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
87
试验地点
1
主要终点
Presence of Central Sensitization

研究概览

简要总结

The aim of this study was to evaluate the relationship between treatment outcomes and central sensitization levels in patients who received intra-articular injections for frozen shoulder.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being between 18 and 75 years of age
  • More than one-third of the active and passive movement of the painful shoulder is limited in two or more planes
  • Having pain and limited movement in the shoulder for 3-12 months

排除标准

  • Having bilateral shoulder pain
  • Patients with incomplete study data
  • Having cervical radiculopathy
  • Having a predominant central sensitization syndrome (such as fibromyalgia, chronic fatigue syndrome)
  • Patients taking antidepressants or anticonvulsants that may affect central sensitization
  • Having a history of rheumatological disease
  • Having a history of active malignancy
  • Patients receiving treatment for active psychiatric disorders
  • Having a history of trauma and/or surgery in the same shoulder region
  • Patients who received local shoulder injections and/or physical therapy within the last 3 months
  • Patients with calcific tendonitis, glenohumeral osteoarthritis, or acromioclavicular joint osteoarthritis on plain radiographs
  • Having a full-thickness rotator cuff tear on shoulder ultrasound

结局指标

主要结局

Presence of Central Sensitization

时间窗: Baseline

Patients' levels of central sensitization will be assessed using the Central Sensitization Inventory (CSI). The CSI consists of 25 items, each scored from 0 to 1. A score of 40 or higher indicates the presence of central sensitization.

次要结局

  • Post-injection pain severity of patients(Baseline)
  • Patients' nighttime pain severity(Baseline)
  • Pressure pain threshold around the shoulder(Baseline)
  • Patients' daytime pain severity(Baseline)
  • Shoulder-related disability and activities of daily living(Baseline)

研究者

发起方
Sultan 1. Murat State Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Alper Mengi

Associate Professor

Sultan 1. Murat State Hospital

研究点 (1)

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