Traditional Chinese and Western Medicine for Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Keywords

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Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Observational

A cohort study will be used to collect patient data, analyze the clinical characteristics, TCM syndromes, and treatment of knee osteoarthritis in China

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Zhong Lidan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda Zhong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Baptist University

Locations

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Hong Kong

Kowloon Tong, Kowloon, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Linda Zhong, MD, PhD

Role: CONTACT

Phone: 34116523

Email: [email protected]

Facility Contacts

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Linda Zhong, MD,PhD

Role: primary

Other Identifiers

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TCMWM-KOA

Identifier Type: -

Identifier Source: org_study_id

Traditional Chinese and Western Medicine for Knee Osteoarthritis

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Observational

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM

China-Japan Friendship Hospital

First Affiliated Hospital of Harbin Medical University

Henan Provincial People's Hospital

Jiangsu Province Hospital of Traditional Chinese Medicine

The First Affiliated Hospital with Nanjing Medical University

Affiliated Hospital of Nanjing University of Chinese Medicine

Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region

First Affiliated Hospital, Helongjiang University of Chinese Medicine

Integrated Hospital of Traditional Chinese Medicine, Southern Medical University

Ruijin Hospital

The Second Clinical Medical College of Zhejiang University of Traditional Chinese Medicine

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Southwest Hospital, China

The Second People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

ShuGuang Hospital

Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of TCM

Shanghai University of Traditional Chinese Medicine

Dongzhimen Hospital, Beijing

Nanfang Hospital, Southern Medical University

The First Affiliated Hospital of Nanchang University

Hong Kong Baptist University

Responsible Party

Zhong Lidan

Principal Investigators

Linda Zhong, MD, PhD

Locations

Hong Kong

Countries

Central Contacts

Linda Zhong, MD, PhD

Facility Contacts

Linda Zhong, MD,PhD

Other Identifiers

TCMWM-KOA