The Danish Child and Adolescent Musculoskeletal Pain (ChiBPS) Cohort: Protocol for a Prospective Nationwide Cohort Study in General Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Activity limiting pain
研究概览
简要总结
Musculoskeletal (MSK) pain in adolescents is much more persistent than commonly appreciated. It has previously been described as a self-limiting condition, but several studies indicate otherwise. In a cohort study of 564 11-year olds with weekly MSK pain, 50% of the participants still reported pain after one year. Prospective cohort studies of adults in general practice show that 16-32% of patients with knee pain still have pain after a year. In accordance with this, Kastelein et al. found that 21% of 12 to 35-year-old patients had knee pain six years after initial general practitioner (GP) contact. Collectively, these studies highlight that a significant proportion of adolescents will continue to report pain even years after the initial onset of pain.
Can the adolescents with a high risk of MSK pain at follow-up be investigated? Our recent systematic review on children and adolescents with MSK pain indicates that female sex, depression, anxiety, and parental pain are associated with a higher risk of MSK pain at follow-up. However, the validity of these prognostic factors may be questioned as they have been tested in single cohorts and not validated in new external cohorts. Moreover, in accordance with our results, other studies identify emotional problems, psychological symptoms, and frequent exercise associated to a higher risk of MSK pain at follow-up. Given the paucity of high-quality evidence for prognostic factors in childhood and adolescent MSK pain, robust studies are needed to further explore prognostic factors in this population. The investigators want to follow up on this need and conduct a cohort study with a similar aim as in their review; to investigate prognosis in youth MSK pain. In this cohort study, the investigators will limit their participant group to those who are 8-19 years old, because the participants have to be able to provide self-reported data on a questionnaire. Participants aged 0-7 years will not be included as they will have difficulties in doing so and because they i) only represent 2% of all patients consulting GPs in Denmark, with a musculoskeletal complaint and ii) were sparsely represented in our systematic review which included a total of 23.933 patients.
At present we lack age-specific prognostic factors in adolescents with MSK pain, although multiple prognostic factors have been identified in adult MSK pain. One systematic review found that higher pain severity upon presentation to the GP, longer pain duration, multiple-site pain, anxiety and/or depression, higher somatic perceptions and/or distress, low social support, higher baseline disability, and greater movement restriction were all associated with a poor prognosis. Systematic reviews on adult knee pain suggest an association between low/middle education level, non-skeletal comorbidity, duration of knee symptoms of > 3 months, bilateral knee symptoms, self-reported warm knee, history of non-traumatic knee symptoms, valgus alignment and an unfavorable prognosis. Similar to findings in patients with adult low back pain, there was high evidence that fear-avoidance beliefs and meagre social support at work were associated with an poor prognosis.
If future studies are to tailor and target treatment for the adolescents with the highest risk of long-standing MSK pain, there is a need to identify prognostic factors for an unfavorable prognosis. The aim of this prospective cohort study is to identify the most important prognostic factors for adolescents with MSK pain in general practice.
详细描述
This study is a prospective cohort study. Setting: Danish general practice clinics across Denmark. We have no interventions for this study. Patients will be followed from their initial pre-recruitment GP consultation and onwards. The pre-defined follow-up assessments are 3, 6 (primary), and 12 months, but the cohort will be followed continuously onwards every 1-5 years.
The aim is to recruit a sample that represents the Danish child and adolescent population with musculoskeletal pain.
The GP is suggested ways of recruitment, in order to choose which best suits the infrastructure of the individual clinic.
Recruitment by an employee:
The employee executes the recruitment process with a screen of all scheduled patients for that day. This prior to the first consultation of the day. The eligibility screening has two criteria: 1. Cause for consultation including a MSK pain complaint and 2. Age 8 to 19 years. The word MSK is written next to the names of all eligible patients to indicate and remind the employee or the consulting GP to hand out the questionnaire to the patient, before they leave the clinic.
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
- 否
入选标准
- •8 to 19 years
- •Self-reported musculoskeletal pain Traumatic pain caused by soft tissue damage, contusion or otherwise (excluding fracture), will be included.
排除标准
- •0-7 or 20+ years
- •Self-reported musculoskeletal pain due to tumor, fracture, infection, or systemic and neurological causes.
- •Parental participation will only be eligible after inclusion of their child. If a child is not eligible, or parental consent is not acquired on behalf of the child or adolescent <15 years of age, the parent will not be eligible for inclusion.
结局指标
主要结局
Activity limiting pain
时间窗: 6 months
Have you experienced pain in the past two weeks that have lead you to not being able to participate in play in the school yard or sparetime activities (ex. football or other sparetime activity? yes/no
Location of activity limiting pain (must include same location as baseline)
时间窗: 6 months
If yes to Primary Outcome 1: Please mark the areas of your body where you have had pain during the past two weeks (pictured a mannequin)
次要结局
- Pain intensity depicted on a NRS (11 point numeric rating scale)(6 months)
研究者
Negar Pourbordbari
Doctor of medicine
Aalborg University
