Clinical trial NCT05133934: Traditional Chinese and Western Medicine for Knee Osteoarthritis
Official title: Investigation of Traditional Chinese and Western Medicine in the Real World of Knee Osteoarthritis: A Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
name: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM
name: China-Japan Friendship Hospital
name: First Affiliated Hospital of Harbin Medical University
name: Henan Provincial People's Hospital
name: Jiangsu Province Hospital of Traditional Chinese Medicine
name: The First Affiliated Hospital with Nanjing Medical University
name: Affiliated Hospital of Nanjing University of Chinese Medicine
name: Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
name: First Affiliated Hospital, Helongjiang University of Chinese Medicine
name: Integrated Hospital of Traditional Chinese Medicine, Southern Medical University
name: Ruijin Hospital
name: The Second Clinical Medical College of Zhejiang University of Traditional Chinese Medicine
name: Affiliated Hospital of Shandong University of Traditional Chinese Medicine Hospital
name: Southwest Hospital, China
name: The Second People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: ShuGuang Hospital
name: Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of TCM
name: Shanghai University of Traditional Chinese Medicine
name: Dongzhimen Hospital, Beijing
name: Nanfang Hospital, Southern Medical University
name: The First Affiliated Hospital of Nanchang University
First posted: 2021-11-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5000 patients who meet the diagnostic criteria for knee osteoarthritis from the 23 affiliated hospitals/centers across China will be recruited

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. The patient has repeated knee joint pain in the past month;
2. 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;
3. Age ≥50 years old;
4. Morning stiffness time ≤30min;
5. 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.

Exclusion Criteria:

Patients who do not meet the diagnostic criteria for knee osteoarthritis

Primary outcomes:
measure: Patient-assessed Pain (rest pain) Visual Analog Scale (VAS) score
timeFrame: 1 month
measure: The Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 1 month
measure: WOMAC Knee Osteoarthritis Index Score
timeFrame: 1 month
measure: TCM Syndrome Differentiation and Symptom Score
timeFrame: 1 month
Secondary outcomes:
measure: Knee Joint Function
timeFrame: 1 month
measure: Morning Stiffness Time (in minutes)
timeFrame: 1 month
measure: 9-Item Patient Health Questionnaire (PHQ-9),
timeFrame: 1 month
measure: 12-Item Short Form Survey (SF-12) for Quality of Life of Patients
timeFrame: 1 month
measure: Complete blood count (CBC)
timeFrame: 1 month
measure: C-reactive Protein (CRP)
timeFrame: 1 month
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: 1 month
measure: Liver Function
timeFrame: 1 month
measure: Kidney Function
timeFrame: 1 month
measure: Urine Routine
timeFrame: 1 month
measure: Examination of X-Ray
timeFrame: 1 month
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Hong Kong
state: Kowloon
Study officials:
affiliation: Hong Kong Baptist University
name: Linda Zhong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: