---
title: Traditional Chinese and Western Medicine for Knee Osteoarthritis
nct_id: NCT05133934
overall_status: UNKNOWN
sponsor: Hong Kong Baptist University
study_type: OBSERVATIONAL
primary_condition: Knee Osteoarthritis
countries: Hong Kong
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05133934.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05133934"
ct_last_update_post_date: 2021-11-24
last_seen_at: "2026-05-12T06:35:22.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05133934](https://clinicaltrials.gov/study/NCT05133934)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 5000
- **Lead Sponsor:** Hong Kong Baptist University
- **Collaborators:** Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, 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 of Heilongjiang Chinese Medicine University, 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
- **Conditions:** Knee Osteoarthritis
- **Start Date:** 2021-10-01
- **Completion Date:** 2024-12
- **CT.gov Last Update:** 2021-11-24

## 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

- **Minimum age:** 50 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## 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

## Primary Outcomes

- **Patient-assessed Pain (rest pain) Visual Analog Scale (VAS) score** _(time frame: 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.
- **The Knee Injury and Osteoarthritis Outcome Score (KOOS)** _(time frame: 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** _(time frame: 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** _(time frame: 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)

## Secondary Outcomes

- **Knee Joint Function** _(time frame: 1 month)_
- **Morning Stiffness Time (in minutes)** _(time frame: 1 month)_
- **9-Item Patient Health Questionnaire (PHQ-9),** _(time frame: 1 month)_
- **12-Item Short Form Survey (SF-12) for Quality of Life of Patients** _(time frame: 1 month)_
- **Complete blood count (CBC)** _(time frame: 1 month)_
- **C-reactive Protein (CRP)** _(time frame: 1 month)_
- **Erythrocyte Sedimentation Rate (ESR)** _(time frame: 1 month)_
- **Liver Function** _(time frame: 1 month)_
- **Kidney Function** _(time frame: 1 month)_
- **Urine Routine** _(time frame: 1 month)_
- **Examination of X-Ray** _(time frame: 1 month)_

## Locations (1)

- Hong Kong, Kowloon Tong, Kowloon, Hong Kong — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hong kong|kowloon tong|kowloon|hong kong` — added _(2026-05-12)_

---

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