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

NCT ID: NCT02998957

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-09-30

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

AcuTENS

Intervention Type: DEVICE

Stimulation of acupuncture point Dingchuan using transcutaneous electrical nerve stimulation (TENS) instead of needles

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.

Group Type: SHAM_COMPARATOR

Sham AcuTENS

Intervention Type: DEVICE

Portable TENS electrostimulation device with no electrical output

Interventions

AcuTENS

Stimulation of acupuncture point Dingchuan using transcutaneous electrical nerve stimulation (TENS) instead of needles

Intervention Type: DEVICE

Sham AcuTENS

Portable TENS electrostimulation device with no electrical output

Intervention Type: DEVICE

Other Intervention Names

TENS; Acupoint transcutaneous electrical nerve stimulation

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Sant Joan de Déu

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Sant Joan de Déu de Manresa

Manresa, Barcelona, Spain

Site Status: RECRUITING

Parc Sanitari de Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Hospital del Mar

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Carlres Fernández, MSc

Role: CONTACT

carlesfj@blanquerna.url.edu

0034651503494

Facility Contacts

Esther Casado, Dr

Role: primary

ecasado@althaia.cat

Raffaele MD Fiorillo, MD

Role: primary

r.fiorillo@pssjd.org

+34 6770640899

Diego Austin Rodriguez, Dr

Role: primary

darodriguez@parcdesalutmar.cat

Other Identifiers

PIC-195-15

Identifier Type: -

Identifier Source: org_study_id