Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a study protocol for a double-blinded, double-placebo, randomised controlled trial

Abstract

IntroductionKnee osteoarthritis is a common form of arthritis in elderly patients that is characterised by pain and functional limitation. Moxibustion has been employed to relieve chronic pain as an alternative therapy for knee osteoarthritis. However, the evidence of its efficacy is equivocal due to the low methodological quality in most clinical studies. Therefore, we are performing a double-blinded, double-placebo, randomised controlled trial to evaluate the efficacy of moxibustion in participants with knee osteoarthritis.Methods and analysisThis is a multicentre, double-blinded, double-placebo, randomised controlled clinical trial. 144 eligible participants with knee osteoarthritis will be randomly assigned to two different groups in a 1:1 ratio. Participants in the moxibustion group will undergo active moxibustion plus placebo gel, whereas participants in the control group will receive diclofenac sodium gel plus placebo moxibustion. Each participant will receive 12 sessions of active/placebo moxibustion at three acupoints (ST35, ST36 and EX-LE4) as well as 2 months of follow-up. Diclofenac sodium gel or placebo gel at a dose of 4 g per knee will be applied three times per day for 4 weeks. The primary outcome measure will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change at the end of the intervention period from baseline. The secondary outcome measures include changes of other subscales (pain, stiffness and function) of WOMAC, visual analogue scale and patient globalassessment. The safety of moxibustion and diclofenac sodium gel will be assessed at every visit.Ethics and disseminationThis trial has been approved by the Sichuan Regional Ethics Review Committee (permission number: 2015KL-014). The results of this study are expected to provide clinical evidence on the efficacy of moxibustion for pain relief and physical function improvement in patients with knee osteoarthritis. The findings will be submitted for publication in peer-reviewed medical journals and presented at relevant academic conferences.Trial registration numberNCT02769572.

Prophylactic Moxibustion in Preventing Postoperative Urinary Retention of Hemorrhoidectomy: A Study Protocol for a Randomized Controlled Trial

“…Heat is supposed to be the most important factor of moxibustion, and the warm stimulation of moxibustion could be easily distinguished from sham moxibusiton. Although there are several reports about sham moxibustion devices used in clinical trials (30)(31)(32), it cannot fully be achieved. Thus, double-blinding and placebo control will not be involved in this study.…”

“…It made the placebo effect an inseparable part of moxibustion efficacy. It has been previously discussed that there might be placebo effects involved in intervention with moxibusion ( 30 , 31 ). When analyzing the results, the placebo effect should be taken into consideration in our study.…”

Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a double-blinded, double-placebo, randomized controlled trial

“…The trial protocol adhered to the CONSORT (Consolidated Standards of Reporting Trails) and STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) guidelines [24]. The protocol was published previously [25]. This research has been approved by the Sichuan Regional Ethics Review Committee (permission number 2015KL-014).…”

“…Our trial was a double-blinded, double-placebo trial that reduced the effects of psychological factors and maintained the same conditions throughout the trial. We applied the new moxibustion device invented to implementation of active / placebo in a blinded moxibustion [25]. The placebo moxibustion device resembled the active one in appearance, except the bottom of the device.…”