Larsson Meh, Nordeman L, Holmgren K, Grimby-Ekman A, Hensing G, Björkelund C, Bergman S, Ekhammar A, Dottori M, Bernhardsson S
Department of Education, Research and Development Primary Health Care, Region Västra Götaland, Gothenburg, Sweden.
Unit of Physiotherapy, Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.
BMC Musculoskelet Disord. 2020 Nov 28;21(1):790. doi: 10.1186/s12891-020-03790-5.
Musculoskeletal pain is globally a leading cause of physical disability. Many musculoskeletal-related pain conditions, such as low back pain, often resolve spontaneously. In some individuals, pain may recur or persist, leading to ong-term physical disability, reduced work capacity, and sickness absence. Early identification of individuals in which this may occur, is essential for preventing or reducing the risk of developing persistent musculoskeletal pain and long-term sickness absence. The aim of the trial described in this protocol is to evaluate effects of an early intervention, the PREVSAM model, on the prevention of sickness absence and development of persistent pain in at-risk patients with musculoskeletal pain.
Eligible participants are adults who seek health care for musculoskeletal pain and who are at risk of developing persistent pain, physical disability, and sickness absence. Participants may be recruited from primary care rehabilitation centres or primary care healthcare centres in Region Västra Götaland. Participants will be randomised to treatment according to the PREVSAM model (intervention group) or treatment as usual (control group). The PREVSAM model comprises an interdisciplinary, person-centred rehabilitation programme, including coordinated measures within primary health care, and may include collaboration with participants' employers. The primary outcome sickness absence is operationalised as the number and proportion of individuals who remain in full- or part-time work, the number of gross and net days of sickness absence during the intervention and follow-up period, and time to first sickness absence spell. Secondary outcomes are patient-reported short-term sickness absence, work ability, pain, self-efficacy, health-related quality of life, risk for sickness absence, anxiety and depression symptoms and physical disability at 1 and 3 months after inclusion (short-term follow-up), and at 6 and 12 months (long-term follow-up). A cost-effectiveness analysis is planned and drug consumption will be investigated.
The study is expected to provide new knowledge on the effectiveness of a comprehensive rehabilitation model that incorporates early identification of patients with musculoskeletal pain at risk for development of sickness absence and persistent pain. The study findings may contribute to more effective rehabilitation processes of this large patient population, and potentially reduce sickness absence and costs.
ClinicalTrials.gov Protocol ID: NCT03913325 , Registered April 12, 2019. Version 2, 10 July 2020. Version 2 changes: Clarifications regarding trial aim and inclusion process.
肌肉骨骼疼痛在全球范围内是导致身体残疾的主要原因。许多与肌肉骨骼相关的疼痛病症，如腰痛，通常会自发缓解。在一些个体中，疼痛可能会复发或持续存在，导致长期身体残疾、工作能力下降和病假缺勤。尽早识别可能出现这种情况的个体，对于预防或降低持续性肌肉骨骼疼痛和长期病假缺勤的风险至关重要。本方案中描述的试验目的是评估一种早期干预措施——PREVSAM模型，对预防有肌肉骨骼疼痛风险的患者的病假缺勤和持续性疼痛发展的效果。
符合条件的参与者是因肌肉骨骼疼痛寻求医疗护理且有发展为持续性疼痛、身体残疾和病假缺勤风险的成年人。参与者可从西约塔兰地区的初级保健康复中心或初级保健医疗中心招募。参与者将根据PREVSAM模型随机分组接受治疗（干预组）或接受常规治疗（对照组）。PREVSAM模型包括一个跨学科的、以患者为中心的康复计划，包括初级卫生保健中的协调措施，可能还包括与参与者雇主的合作。主要结局病假缺勤通过在干预和随访期间仍全职或兼职工作的个体数量和比例、病假缺勤的总天数和净天数以及首次病假缺勤的时间来衡量。次要结局包括患者报告的短期病假缺勤、工作能力、疼痛、自我效能、健康相关生活质量、病假缺勤风险、焦虑和抑郁症状以及纳入后1个月和3个月（短期随访）以及6个月和12个月（长期随访）时的身体残疾情况。计划进行成本效益分析并调查药物消费情况。
该研究有望提供关于一种综合康复模型有效性的新知识，该模型纳入了对有病假缺勤和持续性疼痛发展风险的肌肉骨骼疼痛患者的早期识别。研究结果可能有助于这一庞大患者群体更有效的康复过程，并有可能减少病假缺勤和成本。
ClinicalTrials.gov协议编号：NCT03913325，2019年4月12日注册。2020年7月10日版本2。版本2的更改：关于试验目的和纳入过程的澄清。
