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临床试验/NCT06402409
NCT06402409招募中不适用

Workpackage 1: Baseline Prevalence and Implications of Multimorbidity for the Management of Spinal Pain Workpackage 2: The Influence of Multimorbidity Treatment Burden on Long-term Prognosis of Individuals With Spinal Pain

Jacob Christiansen Gandløse1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Health related quality of life

研究概览

简要总结

Spinal pain is frequently accompanied by other chronic conditions (multimorbidity) and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions.

Therefore the aims of the two studies are to:

Work package 1 - Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics. Examine associations with relevant health-related factors and cover the significance of multimorbidity in the diagnostic process, referral patterns and healthcare utilization.

Work package 2: Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation.

Across both work packages data will be derived from individuals initially referred to the Department of Rheumatology at Aalborg University Hospital (AaUH) or the Medical Spine Clinic in Silkeborg (MSCS).

详细描述

Background:

Spinal pain is frequently accompanied by other chronic conditions (multimorbidity) and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions.

Objectives:

Work package 1: Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics. Examine associations with various health-related factors and cover the significance of multimorbidity in the diagnostic process, referral patterns and healthcare utilization.

Work package 2: Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old or above
  • Are diagnosed with neck or back pain
  • Diagnosis is established by or confirmed by a rheumatologist (clinical expert opinion)
  • Speak, read and understand Danish

排除标准

  • Withdraw consent

研究组 & 干预措施

Group 2: Low treatment burden

Individuals scoring a total of below 10 points (but over 0) on the Multimorbidity Treatment Burden Questionnaire, reflecting low perceived treatment burden.

Group 1: No treatment burden

Individuals scoring a total of 0 points on the Multimorbidity Treatment Burden Questionnaire, reflecting no perceived treatment burden.

Group 3: Medium treatment burden

Individuals scoring a total of between 10 and 22 points on the Multimorbidity Treatment Burden Questionnaire, reflecting medium perceived treatment burden.

Group 4: High treatment burden

Individuals scoring a total of over 22 points on the Multimorbidity Treatment Burden Questionnaire, reflecting high perceived treatment burden.

结局指标

主要结局

Health related quality of life

时间窗: EQ-5D-5L will be collected at baseline, 3, 6, and 12 months of follow-up.

The EQ-5D-5L questionnaire is a standardized measure of health-related quality of life recommended for multimorbidity research. The EQ-5D-5L assesses health status across five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-point ordinal scale ranging from 1 (indicating no problems) to 5 (indicating extreme difficulties) The EQ-5D index score can be regarded as a continuous outcome and ranges from -0.624 to 1, with higher scores indicating better general health and quality of life.

次要结局

  • Brief Pain Inventory(BPI will be collected at baseline, 3, 6, and 12 months of follow-up.)

研究者

发起方
Jacob Christiansen Gandløse
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jacob Christiansen Gandløse

Principal investigator

Aalborg University Hospital

研究点 (1)

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