Knee Osteoarthritis Clinical Trial
Official title:
The Effectiveness of Moxibustion Treatment for Osteoarthritis of the Knee : a Double-blinded, Double-dummy, Randomized Controlled Trial
This is a multicenter , double-blinded, double-dummy, randomized controlled clinical trial to evaluate the efficacy of moxibustion for osteoarthritis of the knee.
Aim: To evaluate the effectiveness of moxibustion treatment for patients with osteoarthritis
of the knee, with respect to relieving pain, improving the dysfunction and improving their
quality of life as well.
Design: A multicentre, double-blinded, double-dummy, randomized controlled clinical study
will be performed in China. Eligible participants will be randomly assigned to moxibustion
group (real moxibustion plus placebo gel) and the control group (diclofenac sodium gel plus
sham moxibustion) with a 1:1 allocation ratio. Participants in both groups will receive 12
sessions of real/sham moxibustion in 4 weeks at 3 acupoints (ST35, EX-LE4, ST36 ). Either
diclofenac sodium gel or placebo gel will be applied 4 g per knee 4 times daily for 4 weeks.
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 primary outcome measure will be the change of the global scale of
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the end of the
course. The secondary outcomes include the change of other subscales (pain, stiffness, and
function) of WOMAC, Visual Analogue scale (VAS) and Patient Global Assessment (PGA). Safety
will be assessed at every visit.
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