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临床试验/NCT06688929
NCT06688929已完成不适用

Psychosocial and Functional Interactions in the Characterization of Axial Spondyloarthritis

Universidad de Extremadura1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年2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
34
试验地点
1
主要终点
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

研究概览

简要总结

This observational, cross-sectional study aims to characterize patients with axial spondyloarthritis (AxSpA) from a biopsychosocial perspective. The study examines the relationships between psychosocial factors (such as pain catastrophizing, kinesiophobia, and fear-avoidance beliefs) and clinical indicators of disease progression, including functional limitations and disease activity. The primary objective is to identify psychosocial predictors of functionality and disease activity in AxSpA patients, which may guide more personalized therapeutic interventions. Findings could provide insights into the combined effects of physical and psychological aspects on disease management, promoting a holistic approach to AxSpA care.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18 years and older) diagnosed with axial spondyloarthritis (AxSpA) based on the Assessment of SpondyloArthritis International Society (ASAS) criteria.
  • Experiencing symptoms of axial or peripheral involvement.
  • A minimum score of 3/10 on the Numeric Pain Rating Scale (NPRS) during the initial assessment.

排除标准

  • Individuals with other rheumatic or musculoskeletal conditions affecting the spine or joints (e.g., rheumatoid arthritis or osteoarthritis).
  • History of spinal surgery or joint replacement surgery.
  • Receipt of corticosteroid injections or other pharmacological treatments targeting inflammation within six weeks prior to data collection.
  • Any ongoing medico-legal conflicts that could interfere with study participation.

结局指标

主要结局

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

时间窗: Baseline (single assessment at the start of the study)

This primary outcome measure will assess disease activity in patients with axial spondyloarthritis using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI is a validated, self-reported measure that evaluates symptoms such as fatigue, spinal pain, joint pain, and morning stiffness on a scale from 0 to 10, where higher scores indicate higher disease activity.

Bath Ankylosing Spondylitis Functional Index (BASFI)

时间窗: Baseline (single assessment at the start of the study)

A self-reported index measuring functional limitations in ankylosing spondylitis patients. It evaluates the ability to perform daily activities, with scores ranging from 0 to 10, where higher scores indicate greater functional impairment.

Bath Ankylosing Spondylitis Metrology Index (BASMI)

时间窗: Baseline

An index measuring spinal mobility in ankylosing spondylitis, using measurements of lateral lumbar flexion, tragus-to-wall distance, cervical rotation, lumbar flexion (modified Schober test), and intermalleolar distance. Each component is scored on a continuous scale from 0 to 10.

次要结局

  • Numeric Pain Rating Scale (NPRS)(Baseline)
  • Range of Motion (ROM)(Baseline)
  • Pressure Pain Threshold (PPT)(Baseline)
  • Cervical Joint Position Sense Error (JPSE)(Baseline)
  • Lumbar Repositioning Error (LRE)(Baseline)

研究者

发起方
Universidad de Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Fernández-Morales

Clinical Professor

Universidad de Extremadura

研究点 (1)

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