Investigation of Traditional Chinese and Western Medicine in the Real World of Knee Osteoarthritis: A Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- The Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
A cohort study will be used to collect patient data, analyze the clinical characteristics, traditional Chinese medicine (TCM) syndromes, and treatment of knee osteoarthritis (KOA) in China to accumulate clinical data and clarify the status of KOA in the real world background. It will lay a clinical foundation for further study of KOA in the future, and bring certain clinical value for Chinese patients with KOA.
详细描述
This is a multicenter cohort study. It is planned to carry out multicenter investigation and research on the current situation of knee osteoarthritis in the real world, conduct large-scale investigation on the clinical population of patients with knee osteoarthritis, and establish a research, quality control, data management and statistical analysis platform for the clinical practical application of knee osteoarthritis and hospital registration. This study aims to discover the current clinical characteristics, TCM syndromes, and treatment status of patients with knee osteoarthritis in China, and provide reliable data support for the clinical treatment of KOA. It is estimated that 5000 patients from 23 centers across China will be recruited. Various demographic and disease-related information will be documented, including name, gender, age, job category, disease course, medical consultation experience, treatment satisfaction and so on. Patients will also complete a series of scales, containing Visual Analog Scale (VAS) Score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, 9-item patient health questionnaire (PHQ-9), SF-12 quality of life, TCM syndrome score sheet, etc. The primary outcome will be the pain (rest pain) VAS, KOOS, WOMAC knee osteoarthritis index score and TCM syndrome score. Secondary outcomes include patient's knee joint function examination, X-ray examination results, blood routine, biochemical indicators and pharmacoeconomic data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has repeated knee joint pain in the past month;
- •X-ray film (standing position or weight-bearing position) shows narrowing of the joint space, subchondral bone sclerosis and/or cystic degeneration, and osteophyte formation on the joint edges;
- •Age ≥50 years old;
- •Morning stiffness time ≤30min;
- •There is bone friction sound (sensation) during activity.
- •Patients who meet the diagnostic criteria 1 + (any 2 of 2, 3, 4, 5) can be diagnosed as KOA.
排除标准
- •Patients who do not meet the diagnostic criteria for knee osteoarthritis
结局指标
主要结局
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 1 month
KOOS is a self-administered, knee-specific instrument to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales: * Symptoms \& Stiffness (7 items) * Pain (9 items) * Function in daily living (ADL Function) (17 items) * Sport and Recreation Function (5 items) * Quality of Life (4 items) A Likert scale is used and all items have 5 possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the 5 scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
WOMAC Knee Osteoarthritis Index Score
时间窗: 1 month
WOMAC knee osteoarthritis index is a self-administered questionnaire consisting of 24 items divided into 3 subscales: * Pain (5 items): * Stiffness (2 items): * Physical Function (17 items) A Likert scale is used and all items have 5 possible answer options: none (0), mild (1), moderate (2), severe (3), and extreme (4). A total WOMAC score is created by summing the items for all three subscales (0-96), and higher scores indicate worse pain, stiffness, and functional limitations.
TCM Syndrome Differentiation and Symptom Score
时间窗: 1 month
Patients' health as characterized by CM diagnostic pattern \& clinical characteristics is recorded using the standard of TCM syndrome differentiation that adopts the 2019 Chinese Society of Chinese Medicine Clinical Diagnosis and Treatment Guidelines for TCM Orthopedics and Traumatology - Knee Arthritis (Knee Osteoarthritis) Syndrome Differentiation Standard (cold-damp arthralgia syndrome, damp-heat arthralgia syndrome, stagnation of Qi and blood stasis syndrome, liver and kidney deficiency syndrome, and qi and blood weakness syndrome)
Patient-assessed Pain (rest pain) Visual Analog Scale (VAS) score
时间窗: 1 month
The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, 10 centimeters (100 mm) in length, each end of this scale is an extreme label of the symptom, "no pain" (corresponding to the scale of 0) and "pain too intense to be tolerated" (corresponding to the scale of 100). Respondents indicate their degree of acceptance to a statement by specifying a point on the continuous scale in between two endpoints. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
次要结局
- 9-Item Patient Health Questionnaire (PHQ-9),(1 month)
- 12-Item Short Form Survey (SF-12) for Quality of Life of Patients(1 month)
- Kidney Function(1 month)
- Urine Routine(1 month)
- Knee Joint Function(1 month)
- Erythrocyte Sedimentation Rate (ESR)(1 month)
- Complete blood count (CBC)(1 month)
- Liver Function(1 month)
- Examination of X-Ray(1 month)
- Morning Stiffness Time (in minutes)(1 month)
- C-reactive Protein (CRP)(1 month)
研究者
Zhong Lidan
Assistant Professor
Hong Kong Baptist University