Acupoint Transcutaneous Electrical Nerve Stimulation in Hospitalized COPD Patients With Severe Dyspnoea

Efficacy of Transcutaneous Electrical Stimulation at Dingchuan (EX-B1) in Hospitalized COPD Patients With Severe Dyspnoea: Patient and Assessor Blinded Randomized Placebo Control Trial

Introduction:

Chronic obstructive pulmonary disease (COPD) presents with a gradual reduction and little bitterness reversible airflow causing shortness of breath, chronic cough and sputum abnormal. Patients with COPD often suffer exacerbations of their symptoms, particularly dyspnea, causing hospital admissions. Recent studies have shown that acupuncture stimulation transcutánea (AcuTENS) Dingchuan point (EX-B1) could help reduce dyspnea in patients with COPD.

Objective:

The aim of this study was to evaluate the possible utility of adding to the usual treatment stimulation AcuTENS in COPD patients admitted with severe dyspnea.

Methodology:

Patients who agree to participate will be randomly divided into two groups. The intervention group will receive a daily treatment, during the period of hospitalization, 45 minutes stimulation at acupuncture point AcuTENS Dingchuan (EX-B1), while the control group performed the same procedure with a device TENS simulated. The extent of dyspnea in both groups as well as the number of days of hospitalization and the number of drugs consumed.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: AcuTENS; Device: Sham AcuTENS

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlres Fernández, MSc; Phone Number: 0034651503494; Email: carlesfj@blanquerna.url.edu

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital del Mar
    • Contact: Diego Austin Rodriguez, Dr; Email: darodriguez@parcdesalutmar.cat
    • Principal Investigator: Anna Rodó
  • Barcelona
    • Manresa, Barcelona, Spain
      • Recruiting
      • Hospital Sant Joan de Déu de Manresa
      • Contact: Esther Casado, Dr; Email: ecasado@althaia.cat
    • Sant Boi de Llobregat, Barcelona, Spain, 08830
      • Recruiting
      • Parc Sanitari de Sant Joan de Déu
      • Contact: Raffaele MD Fiorillo, MD; Phone Number: +34 6770640899; Email: r.fiorillo@pssjd.org
      • Principal Investigator: Carles Fernández, MSc
      • Principal Investigator: Raffaele Fiorillo, MD
      • Sub-Investigator: Jordi Vilaró, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged between 45 and 70 years, with a diagnose of COPD according to the GOLD guidelines.
2. Patients with one episode of hospitalization for COPD exacerbation in the past year, but not more than three episodes.
3. Smoking habit history of more than 10 packages-year.
4. Patients able to correctly understand and answer the modified Borg scale.
5. Patiens with an initial degree of dyspnoea with a score of at least 5 in the modified Borg scale.
6. Patients recruited for the study during the first 48 hours of their hospitalization.
7. Patients who accept to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Patients with any contraindication for transcutaneous electrical stimulation (patiens with pacemakers, skin injury in the application area ...).
2. Patiens with any cardiovascular, neurological or psychiatric disease that may affect the perception of dyspnea.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AcuTENS; Stimulation using a portable TENS electrostimulation device at Dingchuan point using a biphasic rectangular wave with a frequency of 2Hz and a pulse width of 200 ms. The stimulation will be achieved using the highest intensity tolerated by the patient without pain during 40 minuts. Once a day during 5 consecutive days.	Device: AcuTENS; Stimulation of acupuncture point Dingchuan using transcutaneous electrical nerve stimulation (TENS) instead of needles; Other Names: TENS; Acupoint transcutaneous electrical nerve stimulation
Sham Comparator: Sham AcuTENS; Stimulation using a modified portable TENS electrostimulation device at Dingchuan point with no electrical output, even though the screen will light up and display the same data as in the unmodified device during 40 minuts. Patients in this group will be informed that, due to the frequency of stimulation, it is unlikely that they will feel the electric stimulation. Once a day during 5 consecutive days.	Device: Sham AcuTENS; Portable TENS electrostimulation device with no electrical output

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnoea	Change from baseline using the modified Borg scale	At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization days	Number of days from the time of admission until discharge will be collected from the patient's clinical history	Up to 1 months after discharge
Quantity of drug administered	Amount of drugs administered during the hospitalization will be determined by data collected from the patient's clinical history	Up to 1 months after discharge
Peak expiratory flow	Change from baseline using a peak flow meter	At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.
PaO2		At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
Mortality	Percentage of deaths 3 months after discharge	Up to 3 months after discharge
PaCO2		At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
Arterial blood pH		At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
SaO2		At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
Relapses	Percentage of relapses 3 months after discharge	Up to 3 months after discharge
Readmissions	Percentage of readmissions 3 months after discharge	Up to 3 months after discharge

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 30, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: TENS; Acupuncture; Physiotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
• Other Study ID Numbers: PIC-195-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No