The Effectiveness of a Biopsychosocial Rehabilitation Program in Primary Care (Back on Track) Versus Primary Care as Usual in Patients With Chronic Low Back Pain in Which Psychosocial Factors Minimally Influence Daily Life Functioning: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 16
- 主要终点
- Quebec Back Pain Disability Scale (QBPDS)
研究概览
简要总结
The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new primary care intervention "Back on Track" as compared to usual primary care in patients with non-specific chronic low back pain in which disability levels are moderate and the role of psychosocial factors to this disability is at maximum low (classified as WPN2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic low back pain; defined as pain between scapulae and gluteal region, whether or not with radiation towards one or both legs, present for at least three months.
- •Presence of contributing social and psychological factors, however not complex (WPN2 classification)
- •Age between 18 and 65 year
- •Sufficient knowledge of the Dutch language
- •Acceptance towards the biopsychosocial approach instead of biomedical approach
排除标准
- •Chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture, structural deformation, inflammatory process, radicular syndrome or cauda equina syndrome
- •Pregnancy
- •Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.
研究组 & 干预措施
Back on Track intervention
Back on Track intervention is a biopsychosocial primary care intervention
干预措施: Back on Track intervention (Other)
Back on Track intervention
Back on Track intervention is a biopsychosocial primary care intervention
干预措施: Primary care as usual (Other)
Primary care as usual
Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.
干预措施: Back on Track intervention (Other)
Primary care as usual
Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.
干预措施: Primary care as usual (Other)
结局指标
主要结局
Quebec Back Pain Disability Scale (QBPDS)
时间窗: Change in functional disability between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
The QBPDS is a 20-itemed questionnaire designed to determine the individuals' functional disability level (ranging from 0-100). A higher score reflects higher disability.
次要结局
- Credibility and Expectancy Questionnaire (CEQ)(Directly after the first treatment (in the first week of the intervention))
- EuroQol-5D (EQ-5D)(Change in quality of life between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
- Hospital Anxiety and Depression Scale (HADS)(Change in anxiety and depression between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
- Pain Catastrophizing Scale (PCS)(Change in catastrophizing between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
- Numeric Rating Scale (NRS)(Change in pain intensity between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
- Tampa Scale of Kinesiophobia(Change in kinesiophobia between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
- Pain Self-Efficacy Questionnaire (PSEQ)(Change in self-efficacy between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
- Global Perceived Effect (GPE)(Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
- Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P)(Medical consumption at pre-treatment (baseline), post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up after the end of the treatment)
- Social demographic questionnaire(pre-treatment)
- Treatment questionnaire(Post-treatment (with an expected average of 8 weeks))