Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-28 @ 1:28 AM
Study NCT ID:
NCT05133934
Status:
UNKNOWN
Last Update Posted:
2021-11-24
First Post:
2021-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese and Western Medicine for Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-13', 'studyFirstSubmitDate': '2021-08-12', 'studyFirstSubmitQcDate': '2021-11-13', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-assessed Pain (rest pain) Visual Analog Scale (VAS) score', 'timeFrame': '1 month', 'description': '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.\n\nUsing 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.\n\nA higher score indicates greater pain intensity.'}, {'measure': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '1 month', 'description': "KOOS is a self-administered, knee-specific instrument to assess the patients' opinion about their knee and associated problems.\n\nThe KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales:\n\n* Symptoms \\& Stiffness (7 items)\n* Pain (9 items)\n* Function in daily living (ADL Function) (17 items)\n* Sport and Recreation Function (5 items)\n* Quality of Life (4 items)\n\nA 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."}, {'measure': 'WOMAC Knee Osteoarthritis Index Score', 'timeFrame': '1 month', 'description': 'WOMAC knee osteoarthritis index is a self-administered questionnaire consisting of 24 items divided into 3 subscales:\n\n* Pain (5 items):\n* Stiffness (2 items):\n* Physical Function (17 items)\n\nA Likert scale is used and all items have 5 possible answer options: none (0), mild (1), moderate (2), severe (3), and extreme (4).\n\nA 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.'}, {'measure': 'TCM Syndrome Differentiation and Symptom Score', 'timeFrame': '1 month', 'description': "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)"}], 'secondaryOutcomes': [{'measure': 'Knee Joint Function', 'timeFrame': '1 month', 'description': "knee joint's function Questionnaire"}, {'measure': 'Morning Stiffness Time (in minutes)', 'timeFrame': '1 month', 'description': '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.\n\nProlonged morning stiffness that lasts more than an hour and up to several hours suggest worsened osteoarthritis or other inflammatory types of arthritis.'}, {'measure': '9-Item Patient Health Questionnaire (PHQ-9),', 'timeFrame': '1 month', 'description': 'PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.\n\nThe 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.'}, {'measure': '12-Item Short Form Survey (SF-12) for Quality of Life of Patients', 'timeFrame': '1 month', 'description': "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.\n\nIt 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.\n\nHigher component summary scores indicate better health and better health-related quality of life (HRQoL)."}, {'measure': 'Complete blood count (CBC)', 'timeFrame': '1 month', 'description': 'CBC is done to help evaluate red and white blood cells and hemoglobin, and to monitor the side effects of some OA treatments'}, {'measure': 'C-reactive Protein (CRP)', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Liver Function', 'timeFrame': '1 month', 'description': "Liver function test is done to assess patients' liver function, as abnormal liver function tests are often seen in patients with inflammatory arthritis."}, {'measure': 'Kidney Function', 'timeFrame': '1 month', 'description': "Kidney function test is done to assess patients' kidney function, as kidney toxicity is a potential side effect of some arthritis medications."}, {'measure': 'Urine Routine', 'timeFrame': '1 month', 'description': "Urine test is done to assess patients' kidney function, as kidney toxicity is a potential side effect of some arthritis medications."}, {'measure': 'Examination of X-Ray', 'timeFrame': '1 month', 'description': '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:\n\n* Grade 0 (normal)\n* Grade I (suspicious narrowing of joint space, possibly osteophytes)\n* Grade II (obvious osteophytes, slightly narrowed joint space)\n* Grade III (moderate osteophytes, more obviously narrowed joint space, slightly sclerotic subchondral bone)\n* Grade IV (large number of osteophytes, significantly narrowed joint space, extremely obvious sclerosis changes, joints hypertrophy and obvious deformities)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '5000 patients who meet the diagnostic criteria for knee osteoarthritis from the 23 affiliated hospitals/centers across China will be recruited', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient has repeated knee joint pain in the past month;\n2. 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;\n3. Age ≥50 years old;\n4. Morning stiffness time ≤30min;\n5. There is bone friction sound (sensation) during activity.\n\nPatients who meet the diagnostic criteria 1 + (any 2 of 2, 3, 4, 5) can be diagnosed as KOA.\n\nExclusion Criteria:\n\nPatients who do not meet the diagnostic criteria for knee osteoarthritis'}, 'identificationModule': {'nctId': 'NCT05133934', 'acronym': 'TCMWMKOA', 'briefTitle': 'Traditional Chinese and Western Medicine for Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Baptist University'}, 'officialTitle': 'Investigation of Traditional Chinese and Western Medicine in the Real World of Knee Osteoarthritis: A Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'TCMWM-KOA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'A cohort study will be used to collect patient data, analyze the clinical characteristics, TCM syndromes, and treatment of knee osteoarthritis in China'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon Tong', 'state': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Linda Zhong, MD,PhD', 'role': 'CONTACT', 'email': 'ldzhong0305@gmail.com', 'phone': '34116523'}], 'facility': 'Hong Kong', 'geoPoint': {'lat': 22.33312, 'lon': 114.17969}}], 'centralContacts': [{'name': 'Linda Zhong, MD, PhD', 'role': 'CONTACT', 'email': 'ldzhong0305@gmail.com', 'phone': '34116523'}], 'overallOfficials': [{'name': 'Linda Zhong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hong Kong Baptist University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Baptist University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM', 'class': 'UNKNOWN'}, {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Jiangsu Province Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Nanjing University of Chinese Medicine', 'class': 'OTHER'}, {'name': 'Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Heilongjiang Chinese Medicine University', 'class': 'OTHER'}, {'name': 'Integrated Hospital of Traditional Chinese Medicine, Southern Medical University', 'class': 'UNKNOWN'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'The Second Clinical Medical College of Zhejiang University of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': 'Affiliated Hospital of Shandong University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, {'name': "The Second People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine", 'class': 'UNKNOWN'}, {'name': 'The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'ShuGuang Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of TCM', 'class': 'UNKNOWN'}, {'name': 'Shanghai University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Dongzhimen Hospital, Beijing', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Zhong Lidan', 'investigatorAffiliation': 'Hong Kong Baptist University'}}}}