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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02998957
Enrollment
60
Registered
2016-12-21
Start date
2018-04-01
Completion date
2019-09-30
Last updated
2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Acupuncture, TENS, Physiotherapy

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.

Interventions

DEVICEAcuTENS

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

DEVICESham AcuTENS

Portable TENS electrostimulation device with no electrical output

Sponsors

Fundació Sant Joan de Déu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
DyspnoeaAt baseline, day 1, day 2, day 3 day 4 and day 5 of the study.Change from baseline using the modified Borg scale

Secondary

MeasureTime frameDescription
Quantity of drug administeredUp to 1 months after dischargeAmount of drugs administered during the hospitalization will be determined by data collected from the patient's clinical history
Peak expiratory flowAt baseline, day 1, day 2, day 3 day 4 and day 5 of the study.Change from baseline using a peak flow meter
PaO2At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
MortalityUp to 3 months after dischargePercentage of deaths 3 months after discharge
Hospitalization daysUp to 1 months after dischargeNumber of days from the time of admission until discharge will be collected from the patient's clinical history
Arterial blood pHAt baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
SaO2At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
RelapsesUp to 3 months after dischargePercentage of relapses 3 months after discharge
ReadmissionsUp to 3 months after dischargePercentage of readmissions 3 months after discharge
PaCO2At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)

Countries

Spain

Contacts

Primary ContactCarlres Fernández, MSc
carlesfj@blanquerna.url.edu0034651503494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026