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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 )
4 grams per knee, 4 times per day, for 4 weeks
4 grams per knee, 4 times per day, for 4 weeks
Unnamed facility
Chengdu, Sichuan, China
The change of the global scale of the Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time frame: 4 weeks from baseline
The changes from baseline to 2, 4, 8,12 weeks in the WOMAC subscales (pain, stiffness, and function)
Time frame: at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
The change from baseline to 2, 4, 8,12 weeks in Visual Analogue Scale for the pain intensity.
Time frame: at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
The change of Patient global assessment score
Time frame: 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
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3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 )