A New Application of Moxibustion
Pressure ulcers are
common in the elderly and immobile. Currently, there are few proven effective
treatments for pressure ulcers. This trial aims to evaluate the feasibility,
efficacy and safety of moxibustion for pressure ulcers. This is
a multicentre, two-armed, parallel-design randomised controlled trial (RCT). 30
eligible patients with pressure ulcers will be randomised in a ratio of 1:1 to
the treatment group and control group. The participants in the treatment group
will undergo indirect moxibustion for 30 min before application of a dressing,
one session daily, five sessions weekly for 4 weeks. The patients in the
control group will only receive a dressing, applied in the same way as in the
treatment group. Both groups will be followed up for 3 months. The primary
outcome measures will be wound surface area (WSA) and proportion of ulcers
healed within trial period (PUHTP). The secondary outcomes will be the Pressure
Ulcer Scale for Healing (PUSH Tool), visual analogue scale (VAS) and adverse
events. All outcomes will be evaluated at the beginning of the study, at the
end of the second week, at 4 weeks after randomisation and at 1 and 3 months
after treatment cessation. This trial has undergone ethical
scrutiny and been approved by the ethics review boards of First Affiliated
Hospital of Heilongjiang University of Chinese Medicine and Second Affiliated
Hospital of Heilongjiang University of Chinese Medicine (Permission number:
HZYEYLP2014). The results of this study will provide clinical evidence for the
feasibility, efficacy and safety of moxibustion for pressure ulcers.
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