Pain Clinical Trial
Official title:
A Multicentre, Randomised, Single Blinded, Parallel-group Study of Moxa Smoke Effect in Moxibustion Treating Knee Osteoarthritis
This is a multicentre, randomised, single blinded, parallel-group design clinical trial to assess the effect of moxa smoke in the treatment using moxibustion for Knee Osteoarthritis.
Aim: To assess the effect of moxa smoke in the treatment using moxibustion for knee
osteoarthritis.
Design: This is a multicentre, randomised, single blinded, parallel-group design clinical
trial. 138 eligible participants will be randomly allocated into 2 groups (moxibustion group
or smoke-free moxibustion group) with a 1:1 allocation ratio, and receive 12 sessions of
moxibustion treatment over a period of 4 weeks, three sessions per week. Each session will
last 30 minutes. The whole study period is 13 weeks, with a 1 week run in period, 4 week
treatment phase, and 8 week follow-up phase.The participants will receive moxibustion
treatment at three acupoints (EX-LE04,ST35,ST36). In moxa-free smoke moxibustion group,
investigators place a purification device(Shenzhen Conyson Electronic Technology Co, Ltd,C200
moxa smoke purification device,Shenzhen,China) at the top of the moxibustion to remove the
moxa smoke. The primary measurement outcomes are the mean change in the global scale value of
the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) pain and function
scores from baseline to 4 weeks. The secondary outcomes are the Visual Analogue Scale (VAS)
and the patient global assessment. Investigators will assess participants at the second visit
(before starting moxibustion treatment) and at the 2, 4, 8, and 12 week respectively after
the baseline.
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