Background
Methods/design
Design
Period | Inclusion | Treatment | Follow-up | ||
---|---|---|---|---|---|
Baseline | First assessment | Second assessment | Third assessment | Fourth assessment | |
0 week | 2 weeks after inclusion | 4 weeks after inclusion | 8 weeks after inclusion | 12 weeks after inclusion | |
Inclusion confirmed | √ | ||||
Informed consent | √ | ||||
Randomization and blinding | √ | ||||
Sociodemographic characteristics | √ | ||||
Disease history | √ | √ | |||
Treatment history | √ | √ | |||
Comorbidity | √ | √ | √ | √ | |
Current treatment | √ | √ | √ | √ | |
Outcomes | |||||
WOMAC | √ | √ | √ | √ | √ |
VAS | √ | √ | √ | √ | √ |
PGA | √ | √ | √ | √ | |
Trial evaluation | |||||
Outcome analysis | √ | ||||
Adverse event | √ | ||||
Causes of dropout | √ | ||||
Safety analysis | √ | ||||
Compliance analysis | √ |
Inclusion criteria
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Aged between 40 and 75 years
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Diagnosed with KOA formulated by the American College of Rheumatology (ACR)
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Average severity of knee pain no more than 7 points on a visual analog scale (VAS) for most days during the past month
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Agreed to not use paregoric during the whole treatment phase
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Willingness to participate in a randomized study and to sign the informed consent form.
Exclusion criteria
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Pain in the knee that may be caused by inflammatory, malignant, or autoimmune disease or by traumatic injury
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Serious diseases including cancer, uncontrolled hypertension, diabetes mellitus requiring insulin injection, life-threatening cardiovascular or neurological events, chronic respiratory disease, a hemorrhagic disorder, or serious mental diseases
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Knee replacement surgery, arthroscopy of the affected knee within the past year, steroid or hyaluronic acid injection in the knee joints within the previous 3 months
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Life-threatening cardiovascular or neurological events within the past year
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Physiotherapy or other treatments for osteoarthritis knee pain (with the exception of non-steroidal anti-inflammatory drugs) during the previous 4 weeks
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Current participation in another clinical trial
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Accepted acupuncture, moxibustion, cupping, or herbal medicine within the past 4 weeks.