NCT02769572

Moxibustion in Osteoarthritis of the Knee

The Effectiveness of Moxibustion Treatment for Osteoarthritis of the Knee : a Double-blinded, Double-dummy, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Chengdu University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter , double-blinded, double-dummy, randomized controlled clinical trial to evaluate the efficacy of moxibustion for osteoarthritis of the knee.

Detailed description

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
OTHER	real moxibustion	3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 )
DRUG	placebo gel	4 grams per knee, 4 times per day, for 4 weeks
DRUG	diclofenac sodium gel	4 grams per knee, 4 times per day, for 4 weeks
OTHER	sham moxibustion	3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 )

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2016-05-11
• Last updated: 2020-02-17

Locations

1 site across 1 country: China