Traditional Chinese and Western Medicine for Knee Osteoarthritis

NCT05133934 | Unknown

• 1 other identifier: TCMWM-KOA
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Patient-assessed Pain (rest pain) Visual Analog Scale (VAS) score

  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.

  1 month

• The Knee Injury and Osteoarthritis Outcome Score (KOOS)

  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.

  1 month

• WOMAC Knee Osteoarthritis Index Score

  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.

  1 month

• TCM Syndrome Differentiation and Symptom Score

  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)

  1 month

Secondary Outcomes (11)

• Knee Joint Function

  1 month

• Morning Stiffness Time (in minutes)

  1 month

• 9-Item Patient Health Questionnaire (PHQ-9),

  1 month

• 12-Item Short Form Survey (SF-12) for Quality of Life of Patients

  1 month

• Complete blood count (CBC)

  1 month

Interventions

Observational OTHER

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

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Patients who do not meet the diagnostic criteria for knee osteoarthritis

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine: collaborator
• Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM: collaborator
• China-Japan Friendship Hospital: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Henan Provincial People's Hospital: collaborator
• Jiangsu Province Hospital of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Affiliated Hospital of Nanjing University of Chinese Medicine: collaborator
• Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region: collaborator
• First Affiliated Hospital of Heilongjiang Chinese Medicine University: collaborator
• Integrated Hospital of Traditional Chinese Medicine, Southern Medical University: collaborator
• Ruijin Hospital: collaborator
• The Second Clinical Medical College of Zhejiang University of Traditional Chinese Medicine: collaborator
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine: collaborator
• Southwest Hospital, China: collaborator
• The Second People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: collaborator
• ShuGuang Hospital: collaborator
• Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of TCM: collaborator
• Shanghai University of Traditional Chinese Medicine: collaborator
• Dongzhimen Hospital, Beijing: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (1)

Hong Kong

Kowloon Tong, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Linda Zhong, MD, PhD

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Zhong, MD, PhD

CONTACT

34116523; ldzhong0305@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: November 24, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

HK (1)