| Autor: |
Hon Fai Pang, Hoi Yi Lau, Bacon F.L. Ng, Kin Ho Chan, Ka Man Chu, Jessica Ching, Zhi-Xiu Lin, Kam Leung Chan, Kenny Chan, Tianhe Song |
| Rok vydání: |
2020 |
| Předmět: |
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| Popis: |
BackgroundKnee osteoarthritis (KOA) is a common degenerative joint condition that causes disability and pain amongst the elderly. The prevalence of KOA among persons aged 63 or above is approximately 30%. It is estimated that around 10% of the Hong Kong residents will have KOA by the year 2036. Previous studies have reported the positive effect of Tui-na treatment and Chinese herbal formula Du-Huo-Ji-Sheng Decoction (DHJSD) for KOA treatment. However, the therapeutic effect of the combination of both methods is unknown. The current study aims to evaluate the therapeutic effect of the combined therapy of Tui-na and oral administration of DHJSD on KOA using a randomized controlled design.MethodsThis study protocol describes a prospective, randomized wait-list controlled trial which will be conducted in the Yan Oi Tong Chinese Medicine Clinic cum Training and Research Centres (in Tuen Mun and Islands Districts). The eligible subjects will be randomly assigned to the treatment group and wait-list control group in a 1:1 ratio. Both the treatment and wait-list control groups will receive 8 sessions of Tui-na manipulation. DHJSD will be given to the subjects in the treatment group but not the wait-list group. The primary outcome will be assessed using the WOMAC score at 4 weeks after randomization. The secondary outcomes include the WOMAC scores at 2 weeks and 8 weeks after randomization and the health-related quality of life, the 5-level EQ-5D version (EQ-5D-5L), which will be conducted at 2 and 4 weeks after randomization and at follow-up (8 weeks after randomization).ParticipantsSeventy subjects aged 50 years or above, who meet the criteria of KOA according to the American College of Rheumatology, with Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score ≥ 39 will be recruited.DiscussionThe study will provide clinical evidence for the effectiveness of the combined Tui-na and oral administration of DHJSD for the treatment of subjects with KOA. The study will also provide information for large-scale randomized placebo-controlled trial in the future.Trial registrationClinicalTrials.gov, ID: NCT04492670. Registered on 28 July 2020. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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