Press needle for aspiration pneumonia prevention in older adults: Study protocol for a randomized double-blind placebo-controlled trial

Abstract

Background: Pneumonia is the fifth most common cause of death among the Japanese population, with 97% of the deaths occurring among older adults aged ≥65 years. The incidence ratio of aspiration pneumonia is high among the older adults. Therefore, its prophylaxis is important in geriatric medicine. In our previous studies, we reported that stimulation of acupoints at stomach meridian 36 and kidney meridian 3 of the lower limbs with a press needle improved the swallowing function of patients with dysphagia. Improvements in swallowing function may prevent aspiration pneumonia. This study aims to investigate the protective efficacy of press needle stimulation in the lower limbs for aspiration pneumonia.Methods/design: This is a multicenter, randomized, double-blind, placebo-controlled trial. A total of 140 patients with cerebrovascular disorder and a history of aspiration pneumonia will be recruited from 6 centers and randomly assigned to either the real or sham press needle group in a 1:1 ratio. The press needle will be replaced twice a week. The treatment will be administered bilaterally at acupoints stomach meridian 36 and kidney meridian 3. The primary outcome is the frequency of aspiration pneumonia onset. The secondary outcome is the improvement of the latent time of the swallowing reflex. The study period is of 12-month. The primary outcome will be evaluated throughout the study period, while the 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 the prevention of aspiration pneumonia and the improvement of swallowing function in patients. The results of this study will help support the prophylaxis of aspiration pneumonia.Abbreviations: BI = Barthel index, CRF = case report form, LTSR = latent time of swallowing reflex, MMSE = mini-mental state examination.