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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02998957
• Other study ID #: PIC-195-15
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: September 2019

Study information

• Verified date: September 2018
• Source: Fundació Sant Joan de Déu
• Contact: Carlres Fernández, MSc
• Phone: 0034651503494
• Email: carlesfj[@]blanquerna.url.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Dyspnea
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• AcuTENS
Stimulation of acupuncture point Dingchuan using transcutaneous electrical nerve stimulation (TENS) instead of needles
• Sham AcuTENS
Portable TENS electrostimulation device with no electrical output

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona
Spain	Hospital Sant Joan de Déu de Manresa	Manresa	Barcelona
Spain	Parc Sanitari de Sant Joan de Déu	Sant Boi de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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)
Secondary	Mortality	Percentage of deaths 3 months after discharge	Up to 3 months after discharge
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Relapses	Percentage of relapses 3 months after discharge	Up to 3 months after discharge
Secondary	Readmissions	Percentage of readmissions 3 months after discharge	Up to 3 months after discharge