The study aims to evaluate the therapeutic effect of the Tui-na and oral Chinese medicine on the treatment of KOA. This is a prospective, randomized wait-list controlled trial in patients with knee osteoarthritis (KOA). After 2 weeks screening period, eligible subjects will be randomly assigned to the treatment group and wait-list control group in 1:1 ratio. Subjects will have 4-week of treatment, and then a 4-week follow-up.
The subjects will come for a screening visit at week 0 (baseline), then at week 2, week 4, and week 8 for Chinese medicine practitioner (CMP) investigators assessments. The Western Ontario and McMaster University Osteoarthritis index (WOMAC) and EQ-5D-5L will be assessed and filled up at different timepoints. The treatment group will receive both Tui-na and study medication and the wait-list control group will receive Tui-na alone. CMPs will provide consultation under Chinese medicine theory. Study medication compliance and adverse events will also be assessed at each visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
For administering of Tui-na manipulation practice, responsible Tui-na CMP must have at least 2 years of clinical experience. The pre-trial workshops led by a senior practitioner will be organized to ensure standardization of Tui-na treatment manipulation and procedures.
This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.
The Chinese University of Hong Kong
Hong Kong, Hong Kong
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
Time frame: 4 weeks
EQ-5D-EL questionnaire
to assess health-related quality of life, one part is descriptive has 5 response level, the other part is VAS which ranges from 0 to 100
Time frame: 8 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
Time frame: at 2 weeks and 8 weeks
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