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

NCT02998957 | Unknown

• 1 other identifier: PIC-195-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Keywords

Acupuncture; TENS; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Hospitalization days

  Up to 1 months after discharge

• Quantity of drug administered

  Up to 1 months after discharge

• Peak expiratory flow

  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

  Up to 3 months after discharge

Study Arms (2)

AcuTENS

EXPERIMENTAL

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

Sham AcuTENS

SHAM COMPARATOR

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

Interventions

AcuTENS DEVICE

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

Also known as: TENS, Acupoint transcutaneous electrical nerve stimulation

AcuTENS

Sham AcuTENS DEVICE

Portable TENS electrostimulation device with no electrical output

Sham AcuTENS

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (3)

Hospital Sant Joan de Déu de Manresa

Manresa, Barcelona, Spain

RECRUITING

Parc Sanitari de Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, 08830, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Carlres Fernández, MSc

CONTACT

0034651503494; carlesfj@blanquerna.url.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 21, 2016
• Study Start: April 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

ES (3)