A Prospective Cohort Study With 52 Weeks Follow-up Investigating the Influence of Disease Perception on Functional Outcome Among Patients Referred From General Practice to Secondary Care for Treatment of Low Back Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 828
- 试验地点
- 1
- 主要终点
- Change in Rolland Morris Disability Questionnaire
研究概览
简要总结
The main purpose of the study is to investigate the importance of patients' beliefs regarding staying active despite low back pain, among patients referred from general practice to secondary care treatment in Denmark. It is hypothesised that patients believing that staying active will help them recover will have higher odds of a 30%-improvement in The Roland Morris Disability score after 52 weeks compared to patients disagreeing that staying active will lead to better recovery.
详细描述
Background: According to international guidelines on low back pain (LBP), advice to stay active should be provided from healthcare professionals to all patients with LBP. However, provision of advice to stay active is reported to be diverse. Some primary care healthcare professionals believe that avoidance of activities and work will help the patient recover. Consequently some patients are not receiving optimal advice to stay active and may think that inactivity will help them and consequently achieve less favourable treatment outcomes. Thus, changing patients' beliefs are considered the key decisive factor to change actual behaviour, and by that improve the functional ability of the patients. This should reduce primary health care use and reduce referrals to the more expensive treatments in secondary care. The effect of patients' beliefs on their functional outcomes has to our knowledge never been studied in a population of patients with LBP being referred from primary care to secondary care treatment.
Materials and Methods
This is a prospective cohort study. Data is collected from a consecutive series of 800 adult patients (18+), with low back pain as the dominant musculoskeletal complaint, referred from general practices in Central Denmark Region to the Spine Centre at Silkeborg Regional Hospital. Patients will be excluded in case of spinal fractures or malignancy.
All patients seen at the Spine Centre receive a digital letter with a link to an online questionnaire to be completed approximately one week before their appointment at the Spine Centre. The questionnaire contains questions about their back pain history, present pain (Low Back Pain Rating Scale), disability (Rolland Morris Disability Questionnaire), quality of life (EQ-5D), fear-avoidance questions (Örebro Musculoskeletal Pain Questionnaire), STarT Back Screening tool, questions on average level of physical activity, beliefs about physical activity in relation to back pain, advice received from health professionals about staying active, and questions about employment and housing situation. For those accepting participation the same questionnaire is forwarded by email 52 weeks after the initial visit at the Spine Center.
Expected outcome and perspective: This study will bring knowledge about the associations between patient's disease perceptions and beliefs about staying active despite pain and their functional improvement. Furthermore, the study will clarify to what extent patients perceive to have been given advice to stay active by a primary care health professional. Although this study does not explain why some patients do not have guideline concordant beliefs, it will help inform health care professionals in primary care about the possible potential of an increased primary care attention towards the recommendation of staying active when patients have LBP.
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
- 否
入选标准
- •Low back pain (with or without sciatica) as the dominant musculoskeletal complaint
- •18 years or older
排除标准
- •Spinal fractures
- •Malignancy
结局指标
主要结局
Change in Rolland Morris Disability Questionnaire
时间窗: Change from baseline to 52 weeks
Validated questionnaire containing 23 questions on self-reported disability due to low back pain
次要结局
- Change in Low Back Pain Rating Scale(Change from baseline to 52 weeks)
- Change in proportion on sick leave(Change in proportion of patients on sick leave from baseline to 52 weeks)
- Change in EuroQol 5 Dimensions (quality of life)(Change from baseline to 52 weeks)
- Received consultations in primary sector after referral to secondary care(Measured at 52 week follow-up)
- Change in Major Depression Inventory (depression)(Change from baseline to 52 weeks)