- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05133934
Traditional Chinese and Western Medicine for Knee Osteoarthritis (TCMWMKOA)
Investigation of Traditional Chinese and Western Medicine in the Real World of Knee Osteoarthritis: A Multicenter Cohort Study
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Linda Zhong, MD, PhD
- Phone Number: 34116523
- Email: ldzhong0305@gmail.com
Study Locations
-
-
Kowloon
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Kowloon Tong, Kowloon, Hong Kong
- Recruiting
- Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
Patients who do not meet the diagnostic criteria for knee osteoarthritis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
1 month
|
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:
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
Time Frame: 1 month
|
WOMAC knee osteoarthritis index is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
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
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)
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Joint Function
Time Frame: 1 month
|
knee joint's function Questionnaire
|
1 month
|
Morning Stiffness Time (in minutes)
Time Frame: 1 month
|
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. |
1 month
|
9-Item Patient Health Questionnaire (PHQ-9),
Time Frame: 1 month
|
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. |
1 month
|
12-Item Short Form Survey (SF-12) for Quality of Life of Patients
Time Frame: 1 month
|
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). |
1 month
|
Complete blood count (CBC)
Time Frame: 1 month
|
CBC is done to help evaluate red and white blood cells and hemoglobin, and to monitor the side effects of some OA treatments
|
1 month
|
C-reactive Protein (CRP)
Time Frame: 1 month
|
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.
|
1 month
|
Erythrocyte Sedimentation Rate (ESR)
Time Frame: 1 month
|
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.
|
1 month
|
Liver Function
Time Frame: 1 month
|
Liver function test is done to assess patients' liver function, as abnormal liver function tests are often seen in patients with inflammatory arthritis.
|
1 month
|
Kidney Function
Time Frame: 1 month
|
Kidney function test is done to assess patients' kidney function, as kidney toxicity is a potential side effect of some arthritis medications.
|
1 month
|
Urine Routine
Time Frame: 1 month
|
Urine test is done to assess patients' kidney function, as kidney toxicity is a potential side effect of some arthritis medications.
|
1 month
|
Examination of X-Ray
Time Frame: 1 month
|
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:
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Linda Zhong, MD, PhD, Hong Kong Baptist University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCMWM-KOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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