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

Not Applicable

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: AcuTENS; Device: Sham AcuTENS

• Registration Number: NCT02998957
• Lead Sponsor: Fundació Sant Joan de Déu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-21
• Study Start: 2018-04-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-30
• Last Update Posted: 2018-10-02
• Primary Completion: 2019-06
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AcuTENS	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.
Sham AcuTENS	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.

Primary Outcome Measures

Name	Time	Method
Dyspnoea	At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.	Change from baseline using the modified Borg scale

Secondary Outcome Measures

Name	Time	Method
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)
Mortality	Up to 3 months after discharge	Percentage of deaths 3 months after discharge
Hospitalization days	Up to 1 months after discharge	Number of days from the time of admission until discharge will be collected from the patient's clinical history
Quantity of drug administered	Up to 1 months after discharge	Amount of drugs administered during the hospitalization will be determined by data collected from the patient's clinical history
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)
Peak expiratory flow	At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.	Change from baseline using a peak flow meter
Readmissions	Up to 3 months after discharge	Percentage of readmissions 3 months after discharge
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	Up to 3 months after discharge	Percentage of relapses 3 months after discharge

Trial Locations

Locations (3)

Hospital Sant Joan de Déu de Manresa; 🇪🇸 Manresa, Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Parc Sanitari de Sant Joan de Déu; 🇪🇸 Sant Boi de Llobregat, Barcelona, Spain