Acupoint Transcutaneous Electrical Nerve Stimulation in Hospitalized COPD Patients With Severe Dyspnoea
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| ClinicalTrials.gov Identifier: NCT02998957 |
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Recruitment Status : Unknown
Verified September 2018 by Fundació Sant Joan de Déu.
Recruitment status was: Recruiting
First Posted : December 21, 2016
Last Update Posted : October 2, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Disease, Chronic Obstructive | Device: AcuTENS Device: Sham AcuTENS | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 1, 2018 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | September 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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. |
Device: AcuTENS
Stimulation of acupuncture point Dingchuan using transcutaneous electrical nerve stimulation (TENS) instead of needles
Other Names:
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Sham Comparator: 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. |
Device: Sham AcuTENS
Portable TENS electrostimulation device with no electrical output |
- Dyspnoea [ Time Frame: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. ]Change from baseline using the modified Borg scale
- Hospitalization days [ Time Frame: Up to 1 months after discharge ]Number of days from the time of admission until discharge will be collected from the patient's clinical history
- Quantity of drug administered [ Time Frame: Up to 1 months after discharge ]Amount of drugs administered during the hospitalization will be determined by data collected from the patient's clinical history
- Peak expiratory flow [ Time Frame: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. ]Change from baseline using a peak flow meter
- 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) ]
- Mortality [ Time Frame: Up to 3 months after discharge ]Percentage of deaths 3 months after discharge
- 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) ]
- 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) ]
- 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) ]
- Relapses [ Time Frame: Up to 3 months after discharge ]Percentage of relapses 3 months after discharge
- Readmissions [ Time Frame: Up to 3 months after discharge ]Percentage of readmissions 3 months after discharge
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 45 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998957
| Contact: Carlres Fernández, MSc | 0034651503494 | carlesfj@blanquerna.url.edu |
| Spain | |
| Hospital Sant Joan de Déu de Manresa | Recruiting |
| Manresa, Barcelona, Spain | |
| Contact: Esther Casado, Dr ecasado@althaia.cat | |
| Parc Sanitari de Sant Joan de Déu | Recruiting |
| Sant Boi de Llobregat, Barcelona, Spain, 08830 | |
| Contact: Raffaele MD Fiorillo, MD +34 6770640899 r.fiorillo@pssjd.org | |
| Principal Investigator: Carles Fernández, MSc | |
| Principal Investigator: Raffaele Fiorillo, MD | |
| Sub-Investigator: Jordi Vilaró, PhD | |
| Hospital del Mar | Recruiting |
| Barcelona, Spain | |
| Contact: Diego Austin Rodriguez, Dr darodriguez@parcdesalutmar.cat | |
| Principal Investigator: Anna Rodó | |
| Responsible Party: | Fundació Sant Joan de Déu |
| ClinicalTrials.gov Identifier: | NCT02998957 |
| Other Study ID Numbers: |
PIC-195-15 |
| First Posted: | December 21, 2016 Key Record Dates |
| Last Update Posted: | October 2, 2018 |
| Last Verified: | September 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Acupuncture TENS Physiotherapy |
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Dyspnea Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Signs and Symptoms, Respiratory Lung Diseases, Obstructive |