Acupoint transcutaneous electrical nerve stimulation in hospitalized COPD patients with severe dyspnoea: study protocol for a randomized controlled trial

BACKGROUND: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a major cause of hospital admissions and dyspnoea is its main symptom. Some studies have concluded that a new modality of acupuncture, called acupoint transcutaneous electrical nerve stimulation (acuTENS), could reduce dyspnoea in patients with COPD by increasing β-endorphin levels. However, those trials have been conducted mainly on patients in stable condition. This study aims to determine whether the administration of acuTENS can reduce dyspnoea in patients hospitalized for AECOPD. METHODS: A multicentre randomized control trial with blinding of participants and assessors will be conducted. A sample of 60 patients will be randomly assigned to receive 45 min of either real acuTENS or sham acuTENS treatment once a day for five consecutive days. The trial will be conducted at the “Hospital del Mar” in Barcelona (Spain) and the “Hospital Sant Joan de Déu de Manresa” in Manresa (Spain). The Borg scale at baseline and days 1 to 5 will be the primary outcome. Secondary outcomes will be the duration of the hospitalization, quantity of drugs administrated, expiratory peak flow adverse effects and mortality and readmissions at 3 months. DISCUSSION: AcuTENS is a non-pharmacological, non-invasive and inexpensive intervention. This trial will help to elucidate the potential role of acuTENS in the treatment of AECOPD. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02998957. Recruitment status: Recruiting. First posted: 21 December 2016. Last update posted: 2 October 2018. Trial registration dataset is available in Additional file 1. Protocol version 03. Issue date: 20 March 2018. Author: Carles Fernández.