Spondyloarthritis Inception Cohort of Southern Denmark
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Clinicians diagnosis of axSpA
研究概览
简要总结
People with axial spondyloarthritis (axSpA) experience a diagnostic delay of 6.5 years in men and up to 8.8 years in women. One of the reasons for the diagnostic delay seems to be limited awareness of the disease characteristics in the referring health care professionals in primary care. By raising awareness about the disease, the study aims at reducing the diagnostic delay and improving early treatment. In addition to diagnostic and pharmacological treatment, physical exercise and rehabilitation are recommended in people with axSpA. In Denmark, people with axSpA are only offered free of charge physiotherapy when the disease has progressed to a stage with radiographic changes of the spine even though people in the early stage of axSpA report a similar disease burden.
The overall objective of Spondyloarthritis Inception Cohort of Southern Denmark (SPINCODE) is to set up an axSpA inception cohort among individuals with low back pain ≥ 3 months who are considered to be at risk for axSpA. The investigators aim to learn more about the course of axSpA during the early stage of disease appropriately assess outcomes, including novel imaging techniques and identify predictive outcomes. Moreover, the investigators want to test the effect of an outpatient physiotherapist-coordinated rehabilitation intervention in people suspected of having axSpA.
详细描述
Spondyloarthritis (SpA) affects 0.1-3% of the population in Denmark, i.e. approximately 100.000 individuals. SpA encompasses among other diseases axial spondyloarthritis (axSpA). There is a diagnostic delay of 6.5 years in men and up to 8.8 years in women in people with axSpA and it may partly be due to a lack of awareness of possible SpA in the primary care sector. Structured exercise is recommended for people with axSpA by international organisations. Therefore, information about exercise safety and physical activity guidance by physiotherapists (PT) are recommended. At present, most people with axSpA are not offered support from PTs or occupational therapists in rheumatology outpatient clinics in Denmark, and not all see an outpatient rheumatology nurse for patient education and self-management support although this is recommended. The importance of coherence in rehabilitation across all levels in the health care system has been highlighted by the World Health Organisation (WHO). To gain and maintain benefits from the interdisciplinary rehabilitative initiatives in the rheumatology clinics, patients with axSpA need support in the transition from the rheumatology outpatient clinic to primary care to ensure long-term rehabilitation benefits. In summary, early referral and early rehabilitation in people with SpA are inadequate and need improvement.
Aims:
To set up an axSpA inception cohort among individuals with low back pain ≥ 3 months in the counties of Southern Jutland who are considered to be at risk for axSpA.
To describe the epidemiology, demographics, clinical, laboratory and imaging signatures in a population with low back pain suspected of axSpA and improve awareness about incipient axSpA.
To test the feasibility of a novel outpatient interdisciplinary rehabilitation intervention for patients with low back pain suspected of SpA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of the the health care professionals and patients is not possible in the rehabilitation intervention. The person analysing the data will be blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with low back pain suspected of axSpA will be included based on the following inclusion and
排除标准
- •Inclusion Criteria:
- •Age ≥ 18 years
- •Age at symptom onset ≤ 45 years
- •Currently diagnosed with undifferentiated lower back pain
- •Onset of back pain ≥ 3 months ≤ 3 years at referral
- •Diagnosed with anterior uveitis (AU) and/or psoriasis and/or inflammatory bowel disease (IBD) regardless of human leukocyte antigen B27 (HLA-B27) status
- •HLA-B 27 positivity (obligatory in case of absence of AU, psoriasis or IBD)
- •Imaging findings suggestive of axSpA as defined by trained musculoskeletal radiologists, regardless of HLA-B27 status
- •Patients capable of giving written informed consent
- •Exclusion Criteria:
- •Age < 18 years
- •Age at symptom onset > 45 years
- •Recurrent episodes of low back pain for >3 years
- •Incapable of complying with the examination program for physical or mental reasons
- •Not able to provide written consent
- •Not able to understand Danish
- •A priori SpA diagnosis
- •Contradictions to MRI
- •Treatment with disease modifying antirheumatic drugs (DMARDs) for other conditions
- •Pregnancy
结局指标
主要结局
Clinicians diagnosis of axSpA
时间窗: Baseline, week 6, 24, 48, 72 and 96
The treating rheumatologists diagnosis of axial spondyloarthritis
Health related quality of life
时间窗: Baseline, week 6, week 24, 48, 72 and 96
EuroQol -5-dimension 5 level-version (EQ-5D-5L) is a generic measure to assess population health. Includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The EQ-5D-5L index ranges from 0.00 to 1.00. The highest score, the better health related quality of life
次要结局
- axSpA disease mobility(Baseline, week 6, 24, 48 and 96)
- axSpA patient-reported physical function(Baseline, week 24, 48, 72 and 96)
- Inflammatory back pain (IBP) symptoms(Baseline, week 6, 12, 24, 48, 72, 96)
- dual energy computed tomography of SIJ(Baseline and week 96)
- axSpA disease activity(Baseline, week 24, 48, 72 and 96)
- Physical examination I(Baseline, week 6, 24, 48, 72 and 96)
- Physical examination II(Baseline, week 6, 24, 48, 72 and 96)
- Work(Week 6, 24, 48, 72 and 96)
- Fatigue(Week 6, 24, 48, 72 and 96)
- Sleep(Week 6, 24, 48, 72 and 96)
- Aerobic capacity(Week 6, 24, 48, 72 and 96)
- Symptomatic SpA features I(Baseline, week 6, 24, 48, 72 and 96)
- Symptomatic SpA features II(Baseline, week 6, 24, 48, 72 and 96)
- Symptomatic SpA features V(Baseline, week 6, 24, 48, 72 and 96)
- Magnetic resonance imaging of sacroiliac joints (SIJ) and spine(Baseline and week 96)
- low dose computed tomography of SIJ and spine(Baseline and week 96)
- Symptomatic SpA features III(Baseline, week 6, 24, 48, 72 and 96)
- Self-efficacy(Week 6, 24, 48, 72 and 96)
- Objective physical function(Week 6, 24, 48, 72 and 96)
- Symptomatic SpA features IV(Baseline, week 6, 24, 48, 72 and 96)
- Physicians global assessment of disease activity(Baseline, week 6, 24, 48, 72 and 96)
- radiography SIJ(Baseline)
- Physical activity(Week 6, 24, 48, 72 and 96)
- Symptomatic SpA features VI(Baseline, week 6, 24, 48, 72 and 96)