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临床试验/NCT04148144
NCT04148144已完成不适用

Low Back Pain Among Care-seeking Families in General Practice (The YoungBack Project): a Prospective Parallel Cohort Study in 400 Children and Adolescents and Their Parents

Aalborg University1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年10月18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
13
试验地点
1
主要终点
Worst low back pain during the week prior to consulting the general practitioner.

研究概览

简要总结

Background Low back pain (LBP) is the largest cause of years lived with disability worldwide and often associated with low quality of life, inability to work and low physical activity levels. In Danish general practice, LBP accounts for nearly 10% of all yearly consultations, making it the number one reason for consulting a general practitioner in Denmark. An increase in care-seeking children and adolescents with LBP in general practice is seen in the pre-teen-age-years.

At present, no study has investigated on the natural prognosis of LBP among care-seeking adolescents in general practice. Furthermore, the potential impact of patient and parent-related factors on prognosis remains unknown. The aims of the study are to 1) investigate the natural prognosis of LBP and 2) identify patient and parent-related factors which my influence prognosis.

Methods Adolescents aged 8 to 19 years consulting their general practitioner due to LBP will be invited to participate in this prospective cohort study. One parent of each patient will be invited to be a part of the parallel cohort. Online questionnaires will be used to collect data on patient characterises, pain intensity, pain frequency, medication, health-related quality of life, physical activity and illness perception at baseline and at the one-year follow-up. Data on pain intensity and parent-related worries will be collected through biweekly text messages. LBP will be assessed by latent class analysis.

Discussion This study will be the first to uncover the natural prognosis of LBP within a young, care-seeking population in general practice and to investigate if factors related to the patient or parents influence prognosis.

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
8 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • For adolescents in the primary cohort:
  • age between 8 and 19
  • experiencing low back pain
  • For parents in the parallel cohort:
  • parent or legal guardian of included adolescents

排除标准

  • not providing informed consent.

结局指标

主要结局

Worst low back pain during the week prior to consulting the general practitioner.

时间窗: At 12 month

Is measured on an 100mm visual analogue scale (0mm equals no pain and 100mm equals worst possible pain). Only the adolescents with LBP from the primary cohort is asked this question.

次要结局

  • LBP frequency(At baseline and after 12 month)
  • LBP affecting participation in usual daily activities(At baseline and every month for 12 month)
  • Pain interference(At baseline and every month for 12 month)
  • Health-related quality of life - psychologic wellbeing(At baseline and after 12 month)
  • Health-related quality of life - moods and emotions(At baseline and after 12 month)
  • Illness perception (adolescent)(At baseline and every month for 12 month)
  • Sleep(At baseline and every month for 12 month)
  • LBP within the week prior to being enrolled in the study(At baseline)
  • Health-related quality of life (parent)(At baseline)
  • Illness perception (parent)(At baseline)

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Lund Straszek

Principal Investigator

Aalborg University

研究点 (1)

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