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临床试验/NCT06655714
NCT06655714已完成不适用

Evaluation of Inadequate Response to Ultrasound-Guided Subacromial Corticosteroid Injection in Shoulder Impingement Syndrome: Treatment Failure or Central Sensitization?

Beylikduzu State Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

The aim of this study is to investigate the impact of central sensitization in patients with shoulder impingement syndrome who have shown an inadequate response to ultrasound-guided subacromial corticosteroid injection. Additionally, the patients' pain perception and emotional state will be evaluated, and the relationships between these factors and the treatment response will be analyzed.

详细描述

Seventy-two patients aged 18-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital, diagnosed with shoulder impingement syndrome based on magnetic resonance imaging (MRI), and who received ultrasound-guided corticosteroid injection, will be included in the study. No additional interventions or procedures will be performed for the research. These patients, who were previously assessed and treated in the outpatient clinic, will be invited for a follow-up examination at the 4th week after the injection. During the follow-up, their response to the treatment will be evaluated using the Visual Analog Scale (VAS). A reduction of less than 50% on the VAS by the end of the 4th week will be considered an inadequate response. Patients with inadequate and good responses will be divided into two groups and assessed for central sensitization, pain perception, and emotional state. Central sensitization will be evaluated using the Central Sensitization Inventory (CSI), and hyperalgesia will be assessed using an algometer to measure pressure-pain threshold. Additionally, the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Scale will be used to determine the patients' emotional state and pain perception.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 18-
  • •Diagnosed with shoulder impingement syndrome.
  • •Received ultrasound-guided subacromial corticosteroid injection.
  • •Experienced shoulder pain for at least 6 months.

排除标准

  • •History of surgery or fracture in the shoulder or related areas.
  • •Presence of an active infection.
  • •Received shoulder injection within the last 6 months.
  • •Underwent physical therapy for the shoulder in the last 6 months.
  • •Presence of other musculoskeletal or neurological conditions that could cause shoulder pain (e.g., cervical disc herniation, stenosis, moderate to severe osteoarthritis, adhesive capsulitis, rheumatologic pathologies, infectious joint diseases).

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: 0 day, 4th week

The Visual Analog Scale is a tool used to measure the intensity of pain. It consists of a 10 cm line, where one end represents "no pain" (0) and the other end represents "worst imaginable pain" (10). Patients mark the point on the line that reflects their current pain level. In this study, a reduction of less than 50% on the VAS after 4 weeks is considered an inadequate response to the treatment.

Central Sensitization Inventory (CSI)

时间窗: 0 day, 4th week

The CSI is a self-reported questionnaire used to identify the presence of central sensitization, which is a condition where the central nervous system becomes hypersensitive to stimuli. It consists of 25 items that measure symptoms related to central sensitization syndromes. Higher scores indicate a greater likelihood of central sensitization, which can contribute to persistent pain in conditions like shoulder impingement syndrome.

Pressure-Pain Threshold (PPT) Using Algometer

时间窗: 0 day, 4th week

The Pressure-Pain Threshold is the minimum force applied to the skin that induces pain. In this study, an algometer is used to measure PPT at various points on the body. Lower PPT values indicate increased sensitivity to pressure, which is a sign of hyperalgesia, often associated with central sensitization.

Pain Catastrophizing Scale (PCS):

时间窗: 0 day, 4th week

The PCS is a psychological tool used to assess the extent to which individuals experience catastrophic thoughts related to their pain. It includes 13 items that measure rumination, magnification, and helplessness in response to pain. Higher scores on the PCS suggest that the patient tends to catastrophize pain, which can negatively affect their pain experience and recovery.

Hospital Anxiety and Depression Scale (HADS):

时间窗: 0 day, 4th week

The HADS is a questionnaire used to assess the emotional state of patients, focusing on anxiety and depression. It consists of 14 items, divided into two subscales: one for anxiety (HADS-A) and one for depression (HADS-D). Higher scores indicate greater levels of anxiety or depression, which can influence how patients perceive and cope with their pain.

次要结局

未报告次要终点

研究者

发起方
Beylikduzu State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Busra Sirin

Principle Investigator

Beylikduzu State Hospital

研究点 (1)

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