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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
AcuTENS
Sham AcuTENS
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Acupuncture, TENS, Physiotherapy

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Sant Joan de Déu de ManresaRecruiting
  • Parc Sanitari de Sant Joan de DéuRecruiting
  • Hospital del MarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

AcuTENS

Sham AcuTENS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Dyspnoea
Change from baseline using the modified Borg scale

Secondary Outcome Measures

Hospitalization days
Number of days from the time of admission until discharge will be collected from the patient's clinical history
Quantity of drug administered
Amount of drugs administered during the hospitalization will be determined by data collected from the patient's clinical history
Peak expiratory flow
Change from baseline using a peak flow meter
PaO2
Mortality
Percentage of deaths 3 months after discharge
PaCO2
Arterial blood pH
SaO2
Relapses
Percentage of relapses 3 months after discharge
Readmissions
Percentage of readmissions 3 months after discharge

Full Information

First Posted
November 30, 2016
Last Updated
September 30, 2018
Sponsor
Fundació Sant Joan de Déu
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1. Study Identification

Unique Protocol Identification Number
NCT02998957
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Acupuncture, TENS, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AcuTENS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham AcuTENS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AcuTENS
Other Intervention Name(s)
TENS, Acupoint transcutaneous electrical nerve stimulation
Intervention Description
Stimulation of acupuncture point Dingchuan using transcutaneous electrical nerve stimulation (TENS) instead of needles
Intervention Type
Device
Intervention Name(s)
Sham AcuTENS
Intervention Description
Portable TENS electrostimulation device with no electrical output
Primary Outcome Measure Information:
Title
Dyspnoea
Description
Change from baseline using the modified Borg scale
Time Frame
At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.
Secondary Outcome Measure Information:
Title
Hospitalization days
Description
Number of days from the time of admission until discharge will be collected from the patient's clinical history
Time Frame
Up to 1 months after discharge
Title
Quantity of drug administered
Description
Amount of drugs administered during the hospitalization will be determined by data collected from the patient's clinical history
Time Frame
Up to 1 months after discharge
Title
Peak expiratory flow
Description
Change from baseline using a peak flow meter
Time Frame
At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.
Title
PaO2
Time Frame
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)
Title
Mortality
Description
Percentage of deaths 3 months after discharge
Time Frame
Up to 3 months after discharge
Title
PaCO2
Time Frame
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)
Title
Arterial blood pH
Time Frame
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)
Title
SaO2
Time Frame
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)
Title
Relapses
Description
Percentage of relapses 3 months after discharge
Time Frame
Up to 3 months after discharge
Title
Readmissions
Description
Percentage of readmissions 3 months after discharge
Time Frame
Up to 3 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlres Fernández, MSc
Phone
0034651503494
Email
carlesfj@blanquerna.url.edu
Facility Information:
Facility Name
Hospital Sant Joan de Déu de Manresa
City
Manresa
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Casado, Dr
Email
ecasado@althaia.cat
Facility Name
Parc Sanitari de Sant Joan de Déu
City
Sant Boi de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08830
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele MD Fiorillo, MD
Phone
+34 6770640899
Email
r.fiorillo@pssjd.org
First Name & Middle Initial & Last Name & Degree
Carles Fernández, MSc
First Name & Middle Initial & Last Name & Degree
Raffaele Fiorillo, MD
First Name & Middle Initial & Last Name & Degree
Jordi Vilaró, PhD
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Austin Rodriguez, Dr
Email
darodriguez@parcdesalutmar.cat
First Name & Middle Initial & Last Name & Degree
Anna Rodó

12. IPD Sharing Statement

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

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