Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 8:04 AM
Study NCT ID:
NCT02998957
Status:
UNKNOWN
Last Update Posted:
2018-10-02
First Post:
2016-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupoint Transcutaneous Electrical Nerve Stimulation in Hospitalized COPD Patients With Severe Dyspnoea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-30', 'studyFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnoea', 'timeFrame': 'At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.', 'description': 'Change from baseline using the modified Borg scale'}], 'secondaryOutcomes': [{'measure': 'Hospitalization days', 'timeFrame': 'Up to 1 months after discharge', 'description': "Number of days from the time of admission until discharge will be collected from the patient's clinical history"}, {'measure': 'Quantity of drug administered', 'timeFrame': 'Up to 1 months after discharge', 'description': "Amount of drugs administered during the hospitalization will be determined by data collected from the patient's clinical history"}, {'measure': 'Peak expiratory flow', 'timeFrame': 'At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.', 'description': 'Change from baseline using a peak flow meter'}, {'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', 'description': 'Percentage of deaths 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', 'description': 'Percentage of relapses 3 months after discharge'}, {'measure': 'Readmissions', 'timeFrame': 'Up to 3 months after discharge', 'description': 'Percentage of readmissions 3 months after discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupuncture', 'TENS', 'Physiotherapy'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'Introduction:\n\nChronic 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.\n\nObjective:\n\nThe 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.\n\nMethodology:\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged between 45 and 70 years, with a diagnose of COPD according to the GOLD guidelines.\n2. Patients with one episode of hospitalization for COPD exacerbation in the past year, but not more than three episodes.\n3. Smoking habit history of more than 10 packages-year.\n4. Patients able to correctly understand and answer the modified Borg scale.\n5. Patiens with an initial degree of dyspnoea with a score of at least 5 in the modified Borg scale.\n6. Patients recruited for the study during the first 48 hours of their hospitalization.\n7. Patients who accept to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Patients with any contraindication for transcutaneous electrical stimulation (patiens with pacemakers, skin injury in the application area ...).\n2. Patiens with any cardiovascular, neurological or psychiatric disease that may affect the perception of dyspnea.'}, 'identificationModule': {'nctId': 'NCT02998957', 'briefTitle': 'Acupoint Transcutaneous Electrical Nerve Stimulation in Hospitalized COPD Patients With Severe Dyspnoea', 'organization': {'class': 'OTHER', 'fullName': 'Fundació Sant Joan de Déu'}, 'officialTitle': 'Efficacy of Transcutaneous Electrical Stimulation at Dingchuan (EX-B1) in Hospitalized COPD Patients With Severe Dyspnoea: Patient and Assessor Blinded Randomized Placebo Control Trial', 'orgStudyIdInfo': {'id': 'PIC-195-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AcuTENS', '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.\n\nOnce a day during 5 consecutive days.', 'interventionNames': ['Device: AcuTENS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham AcuTENS', '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.\n\nOnce a day during 5 consecutive days.', 'interventionNames': ['Device: Sham AcuTENS']}], 'interventions': [{'name': 'AcuTENS', 'type': 'DEVICE', 'otherNames': ['TENS', 'Acupoint transcutaneous electrical nerve stimulation'], 'description': 'Stimulation of acupuncture point Dingchuan using transcutaneous electrical nerve stimulation (TENS) instead of needles', 'armGroupLabels': ['AcuTENS']}, {'name': 'Sham AcuTENS', 'type': 'DEVICE', 'description': 'Portable TENS electrostimulation device with no electrical output', 'armGroupLabels': ['Sham AcuTENS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manresa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Esther Casado, Dr', 'role': 'CONTACT', 'email': 'ecasado@althaia.cat'}], 'facility': 'Hospital Sant Joan de Déu de Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'zip': '08830', 'city': 'Sant Boi de Llobregat', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raffaele MD Fiorillo, MD', 'role': 'CONTACT', 'email': 'r.fiorillo@pssjd.org', 'phone': '+34 6770640899'}, {'name': 'Carles Fernández, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raffaele Fiorillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jordi Vilaró, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Parc Sanitari de Sant Joan de Déu', 'geoPoint': {'lat': 41.34357, 'lon': 2.03659}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Diego Austin Rodriguez, Dr', 'role': 'CONTACT', 'email': 'darodriguez@parcdesalutmar.cat'}, {'name': 'Anna Rodó', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Carlres Fernández, MSc', 'role': 'CONTACT', 'email': 'carlesfj@blanquerna.url.edu', 'phone': '0034651503494'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundació Sant Joan de Déu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}