Knee OsteoarthritisTCMWMKOANCT05133934
Traditional Chinese and Western Medicine for Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Observational
- How many people
- 5,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2021to Dec 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 5000 patients who meet the diagnostic criteria for knee osteoarthritis from the 23 affiliated hospitals/centers across China will be recruited
Who may be able to join
- 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.
Who cannot join
- Patients who do not meet the diagnostic criteria for knee osteoarthritis
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong
Kowloon Tong, Kowloon
Linda Zhong, MD,PhD, 34116523, ldzhong0305@gmail.com
About this study
Official title: Investigation of Traditional Chinese and Western Medicine in the Real World of Knee Osteoarthritis: A Multicenter Cohort Study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Observational
- Keywords
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
A cohort study will be used to collect patient data, analyze the clinical characteristics, TCM syndromes, and treatment of knee osteoarthritis in China
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 1 month
Secondary outcomes (11)
Knee Joint Function
knee joint's function Questionnaire
Measured: 1 month
Morning Stiffness Time (in minutes)
Morning stiffness time (in minutes) is self recorded by patients daily when they wake up in the morning, to assess the severity of the stiffness.
Prolonged morning stiffness that lasts more than an hour and up to several hours suggest worsened osteoarthritis or other inflammatory types of arthritis.
Measured: 1 month
9-Item Patient Health Questionnaire (PHQ-9),
PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
The severity of depression is categorized into mild, moderate, moderately severe and severe depression. The final question on the PHQ-9 screens for the presence and duration of suicide ideation.
Measured: 1 month
12-Item Short Form Survey (SF-12) for Quality of Life of Patients
The SF-12 is a self-reported quality of life measure to be scored by a researcher, to assess the impact of health on patients' everyday life, and keeps track of how patients feel and how well they are able to do their usual activities.
It consists of 12 questions measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. These health domain scores are aggregated into the physical component summary (PCS) score and the mental component summary (MCS) score.
Higher component summary scores indicate better health and better health-related quality of life (HRQoL).
Measured: 1 month
Complete blood count (CBC)
CBC is done to help evaluate red and white blood cells and hemoglobin, and to monitor the side effects of some OA treatments
Measured: 1 month
C-reactive Protein (CRP)
CRP is done to detect inflammation and test for the activity of the disease; an increased level of CRP suggests other forms of inflammatory arthritis, such as rheumatoid arthritis (RA) instead of osteoarthritis.
Measured: 1 month
Erythrocyte Sedimentation Rate (ESR)
The ESR rate increases as a result of any cause or focus of inflammation. ESR is done to detect inflammation in the body; ESR will be increased in other forms of inflammatory arthritis, such as RA but not in osteoarthritis.
Measured: 1 month
Liver Function
Liver function test is done to assess patients' liver function, as abnormal liver function tests are often seen in patients with inflammatory arthritis.
Measured: 1 month
Kidney Function
Kidney function test is done to assess patients' kidney function, as kidney toxicity is a potential side effect of some arthritis medications.
Measured: 1 month
Urine Routine
Urine test is done to assess patients' kidney function, as kidney toxicity is a potential side effect of some arthritis medications.
Measured: 1 month
Examination of X-Ray
X-rays of the affected knee joints to assess the loss of cartilage, bone damage, bone spurs, and narrowing of the joint space using following grading scale:
- Grade 0 (normal)
- Grade I (suspicious narrowing of joint space, possibly osteophytes)
- Grade II (obvious osteophytes, slightly narrowed joint space)
- Grade III (moderate osteophytes, more obviously narrowed joint space, slightly sclerotic subchondral bone)
- Grade IV (large number of osteophytes, significantly narrowed joint space, extremely obvious sclerosis changes, joints hypertrophy and obvious deformities)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Oct 2021
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- 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, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, 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
- Responsible party
- Principal investigator, Zhong Lidan, Hong Kong Baptist University
- Investigators
- Linda Zhong, MD, PhD, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133934
- Sponsor's protocol ID
- TCMWM-KOA
- Acronym
- TCMWMKOA
- Status last verified
- Nov 2021
- First submitted
- 12 Aug 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Traditional Chinese and Western Medicine in the Real World of Knee Osteoarthritis: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05133934
- Acronym / sponsor ID
- TCMWMKOA / TCMWM-KOA
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- 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, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, 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
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 5000 patients who meet the diagnostic criteria for knee osteoarthritis from the 23 affiliated hospitals/centers across China will be recruited
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who do not meet the diagnostic criteria for knee osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalA cohort study will be used to collect patient data, analyze the clinical characteristics, TCM syndromes, and treatment of knee osteoarthritis in China | Other | – |
Primary outcome
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)
11 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: Undecided
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Zhong, MD, PhD principal investigator
Hong Kong Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Hong Kong Baptist University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Zhong, MD, PhD (34116523, ldzhong0305@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-assessed Pain (rest pain) Visual Analog Scale (VAS) score (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.