WorkUp. Early Structured Care Including Workplace Interventions to Improve Work Ability in Patients With Neck and/or Back Pain. A Prospective Pare Wise Cluster Randomized Controlled Trial in Primary Care With One Year Follow up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 364
- 主要终点
- Work ability
研究概览
简要总结
WorkUp is a prospective cluster randomised controlled trial in primary care. The main purpose is to investigate effects of early structured care based on screening of red flags (signs of serious medical conditions/disease), yellow flags (psychosocial factors, attitude to pain) and blue flags (workplace related factors) and including a workplace intervention according to the method "Convergence Dialogue Meetings" (CDM) for improving work ability, in comparison with treatment as usual, in patients with neck and/or back pain.
详细描述
Musculoskeletal disorders are the most common reasons for sick leave in western countries. Identifying risk factors and predictors for a stable return to work (RTW ) is essential. An evidence-based safe care includes systems for detecting medical conditions with urgent need for care (red flags) and psycho-social risk factors (yellow flags). To maintain work ability, also requires different capacities related to work demands, (physical, mental and social) as well as work environment aspects covered by a "blue flag system".
Since motivation is assumed to drive and sustain human behaviour, patients with back pain seek health care when motivation reaches a threshold level. Patients want to be examined, get treatment and self-care advice to resume normal daily activities. This might lead to improved long-standing results in terms of health, function and work ability.
The investigators hypothesize that WorkUp, a timely tailor-made and evidence-based intervention leads to a faster recovery of health, function and RTW as compared to standard care. This includes the identification of both the patient's risk factors (red, yellow and blue flags) and motivational factors. Based on this screening, a structured tailored intervention will be offered. The WorkUp model comprise of evidence-based treatment and interaction between patient, health care and work place interventions.
The main purpose is to test WorkUp in a comparison study with treatment as usual (TAU) in primary health care (PHC).
Design: A prospective paire wise cluster randomized trial in PHC including a one year clinical follow-up and a three year register follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute and subacute neck and/or back pain (less than three months of duration)
- •a working history of at least four weeks during the last year
- •being at risk for sick leave according to the short form of the Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) (cut off >40)
- •if sickness absent < 60 days.
排除标准
- •identified abuse
- •retirement pension
- •ongoing acute medical treatment
- •pregnancy
研究组 & 干预措施
Structured care & workplace intervention
Through a flow chart the investigators in detail specify the medical and work place interventions (all according to evidence-based guidelines). Red, yellow and blue flags, and motivational factors are identified in a screening investigation. The aim of the screening is to individually tailor the rehabilitation interventions. Physiotherapy interventions are based on a bio-psychosocial and cognitive behavioural therapy perspective. Behavioural medicine treatment principles include careful examination and treatments such as advice to stay active, instructions, OMI, OMT, MDT. The investigators apply interventions based on ergonomics, motivational factors and work place changes according to Convergence Dialogue Meetings (CDM).
干预措施: Structured care & workplace intervention (Other)
Treatment as Usual
Patients follows the PHCs standard schedule and procedures including the so called rehabilitation guarantee
干预措施: Treatment as Usual (Other)
结局指标
主要结局
Work ability
时间窗: Changes from baseline to after treatment (3, 6, 12 months and 2 and 3 years)
Work ability (defined as being at work or being eligible to the labour market during at least four weeks in a row) and time of sickness absence and Return to work. Year 2 and 3 follow-up by register data
次要结局
- Functional ability(Changes from baseline to after treatment (3, 6 and 12 months))
- Physical and psycho-social work environment(Changes from baseline to after treatment (3, 6 and 12 months))
- Pain (distribution and intensity)(Changes from baseline to after treatment (3, 6 and 12 months))
- Patient´s satisfaction(Changes from baseline to after treatemnt (3, 6 and 12 months))
- Health-related quality of life(Changes from baseline to after treatment (3, 6 and 12 months))