Press needle for the Prevention of Aspiration Pneumonia in Elderly People: Study Protocol for a Randomized Double-Blind Placebo-Controlled trial.

Abstract Background: Pneumonia is the fifth most common cause of death among the Japanese, with 97% of deaths occurring among elderly people aged 65 years or older. The incidence ratio of aspiration pneumonia is high for elderly people. Therefore, prophylaxis is important in geriatric medicine. In our previous studies, we reported that stimulation to the acupoints at ST36 and KI3 of the lower limbs with press needle improved the swallowing function of patients with dysphagia. The improvement of swallowing function may prevent aspiration pneumonia. The aim of this study is to investigate the protective efficacy of using press needle stimulation in the lower limbs for aspiration pneumonia.Methods/design: This is a multi-center, randomized double-blind placebo-controlled trial. A total of 140 patients with cerebrovascular disorder with a history of aspiration pneumonia will be recruited from six centers and randomly assigned to either the real press needle group or the sham press needle group in a 1:1 ratio. The press needle will be replaced twice a week. Treatment will be administered bilaterally at acupoints ST36 and KI3. The primary outcome is the frequency of onset of aspiration pneumonia. The secondary outcome is improvement of the latent time of swallowing reflex (LTSR). The investigation period is of 12-month. The primary outcome will be evaluated throughout the period, and secondary outcomes will be assessed at baseline, 1st month, 6th month, and at the end of the investigation period.Discussion: This study will evaluate the effects of press needle on prevention of aspiration pneumonia and improvement of swallowing function of patients. The results of this study will help support the prophylaxis of aspiration pneumonia.Trial registration: UMIN000023123, registered on July 12th, 2016; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026460