Last updated: December 21, 2021
Sponsor: West China Hospital
Overall Status: Completed
Phase
N/A
Condition
Allergies & Asthma
Knee Injuries
Allergy
Treatment
N/AClinical Study ID
NCT03299439
20178159950025
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants aged 40 years or older and diagnosed with mild or moderate kneeosteoarthritis(KOA) are eligible to participate in the study
- The following criteria are used for diagnosis of KOA:
- refractory knee pain for most days in the last month;
- joint space narrowing, sclerosis or cystic change in subchondral bone (asdemonstrated in X-ray);
- laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times)and white blood cell count < 2000/mm3;
- morning stiffness continues less than 30 minutes;
- bone sound exists when joints was taking flexion and/or extension. If a patientmeets criteria 1 and 2, or criteria 1, 3, 4, and 5, a diagnosis of KOA isconfirmed.
Exclusion
Exclusion Criteria: Patients will be excluded if they meet any of the following:
- diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumorsor rheumatism of the knee joint and rheumatoid arthritis;
- present sprain or trauma in the lower limb;
- unable to walk properly due to foot deformity or pain;
- present with mental disorders;
- present with comorbidities including severe cardiovascular disease, liver or kidneyimpairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease;
- females who are pregnant or lactating;
- using physiotherapy treatments for osteoarthritis knee pain;
- have used intra-articular injection of glucocorticoid or viscosupplementation in thepast six months;
- received knee-replacement surgery;
- diagnosed with severe (stage 4, according to Kellgren and Lawrence radiographicclassification) or late clinical stage of KOA;
- have a swollen knee or positive result of floating patella test; or'
- are participating or have participated in the other clinical trials.
Study Design
Total Participants: 666
Study Start date:
October 25, 2017
Estimated Completion Date:
November 20, 2020
Study Description
Connect with a study center
the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan 450003
ChinaSite Not Available
Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital
Wuhan, Hubei 430022
ChinaSite Not Available
Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan 610075
ChinaSite Not Available

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