Traditional Chinese and Western Medicine for Knee Osteoarthritis

Last updated: November 13, 2021
Sponsor: Hong Kong Baptist University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Knee Injuries

Treatment

N/A

Clinical Study ID

NCT05133934
TCMWM-KOA
  • Ages 50-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 jointspace, subchondral bone sclerosis and/or cystic degeneration, and osteophyte formationon 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 asKOA.

Exclusion

Exclusion Criteria: Patients who do not meet the diagnostic criteria for knee osteoarthritis

Study Design

Total Participants: 5000
Study Start date:
October 01, 2021
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Hong Kong

    Kowloon Tong, Kowloon
    Hong Kong

    Active - Recruiting

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