A Population-based Cohort of Osteoarthritis: the Xiangya Osteoarthritis Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,080
- 试验地点
- 1
- 主要终点
- Prevalence of multiple joints osteoarthritis.
研究概览
简要总结
The purpose of this study is to examine the natural history, phenotypes and risk factors of osteoarthritis (OA) and pain at different joints, and to examine the association between OA structure changes, inflammation and pain for knee and hand OA.
详细描述
Objectives:
- To understand the natural history of osteoarthritis (OA) at different joints (knee, hip, hand, foot and lumbar).
- To identify different phenotypes of OA (e.g., generalized OA, rapidly progressive knee and hand OA, tibiofemoral OA and patellofemoral OA), their association with pain (e.g., peripheral pain, central pain, nociceptive pain and neuropathic pain) and consequences.
- To examine risk factors of OA (lifestyle habits, nutritional, metabolic, anatomical and genetic factors, etc.) at each joint as well as multiple joints.
- To determine the association between x-ray structure change, ultrasound synovial changes and pain and other symptoms of OA at knee and hand joints within the large-sample community-based population.
- To predict the progression of knee and hand OA within new-onset early-stage knee and hand OA patients, and to identify the rapidly progressive knee and hand OA phenotypes and their related risk factors.
- To investigate the association between gut microbiota and OA.
- To investigate the association between oral microbiota and OA.
Design: This is a prospective community-based cohort study.
Participants: Subjects included in this study were a randomly selected sample of residents, aged 50 years or older from rural mountainous communities of Longshan County, Hunan Province, China. 4000 people were planned to be recruited, divided into three sub-cohorts. 1,469 participants were enrolled in sub-cohort 1 in 2015, and two follow-ups have been completed in 2016 and 2017. 1,267 participants were enrolled in sub-cohort 2 in 2018. 1,340 participants were enrolled in sub-cohort 3 in 2019. Each sub-cohort will be followed every three years regularly.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50 years old or above
- •Residents of the randomly selected communities
排除标准
- •Inability to give informed consent
- •Terminal or mental illness
- •Pregnant women
结局指标
主要结局
Prevalence of multiple joints osteoarthritis.
时间窗: At enrollment.
Measured by radiographs of multiple joints.
Progression of multiple joints osteoarthritis.
时间窗: At 3, 6, 9, 12 years follow-ups after enrollment.
The changes of joint space and osteophytes are measured by radiographs of multiple joints, to assess the progression of multiple joints osteoarthritis.
Incidence of multiple joints osteoarthritis.
时间窗: At 3, 6, 9, 12 years follow-ups after enrollment.
Measured by radiographs of multiple joints, and the incidence of osteoarthritis can be calculated at each follow-up time point.
次要结局
- Changes of pain intensity of knee, hip, hand and lumbar.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of grip strength.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of hip abductor.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of the results of squatting ability test.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of the results of quantitative sensory testing.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Prevalence of widespread pain.(At enrollment.)
- Prevalence of sarcopenia.(Every round of surveys since year 2018.)
- Changes of pain experience of knee.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Ultrasound detected changes of knee, thigh muscle, and hand.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Incidence of knee/hip/patellofemoral joint pain.(At 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of global assessment of knee and hip.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of the results of stair climbing test.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of neuropathic pain of knee.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of patient's belief about knee pain.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of pain catastrophizing of knee.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Prevalence of knee/hip/patellofemoral joint pain.(At enrollment.)
- Changes of global hand function.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of physical and mental health.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Incidence of sarcopenia.(At 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of pain-related disability of lumbar osteoarthritis.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of the results of 30s repetition chair stand test.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of the results of timed up and go test.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of quadriceps strength.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of the results of 20-meter walk test.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of the results of standing balance test.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of pinch strength.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of hamstrings strength.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Prevalence of nodal osteoarthritis.(At enrollment.)
- Changes of the results of body composition analysis.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)
- Incidence of widespread pain.(At 3, 6, 9, 12 years follow-ups after enrollment.)
- Changes of sleep quality.(At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.)