Clinical trial NCT02998957: Acupoint Transcutaneous Electrical Nerve Stimulation in Hospitalized COPD Patients With Severe Dyspnoea
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Acupuncture
TENS
Physiotherapy
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Dyspnoea
timeFrame: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.
Secondary outcomes:
measure: Hospitalization days
timeFrame: Up to 1 months after discharge
measure: Quantity of drug administered
timeFrame: Up to 1 months after discharge
measure: Peak expiratory flow
timeFrame: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.
measure: PaO2
timeFrame: 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)
measure: Mortality
timeFrame: Up to 3 months after discharge
measure: PaCO2
timeFrame: 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)
measure: Arterial blood pH
timeFrame: 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)
measure: SaO2
timeFrame: 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)
measure: Relapses
timeFrame: Up to 3 months after discharge
measure: Readmissions
timeFrame: Up to 3 months after discharge
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Hospital Sant Joan de Déu de Manresa
state: Barcelona
city: Sant Boi de Llobregat
country: Spain
facility: Parc Sanitari de Sant Joan de Déu
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References: