Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT01804192
Status:
UNKNOWN
Last Update Posted:
2013-03-05
First Post:
2013-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Acupoints Sensation Necessary for Acu-TENS to Elicit Physiological Changes in Healthy Subjects?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054969', 'term': 'Primary Dysautonomias'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-02', 'studyFirstSubmitDate': '2013-02-11', 'studyFirstSubmitQcDate': '2013-03-02', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Blood pressure', 'timeFrame': 'One month afterwards', 'description': 'Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany).'}], 'primaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': 'One month after the intervention', 'description': 'Three ECG electrodes will beapplied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The ECG signals will be transferred to the PowerLab 16/30 (ADInstruments Pty Ltd. NSW, Australia) for data acquisition and analysis of the HRV.'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'One month after the study', 'description': 'Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The heart rate (HR) will be measured.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acu-TENS', 'MAP', 'HR', 'HRV'], 'conditions': ['Autonomic Nervous System Disorder']}, 'descriptionModule': {'briefSummary': 'Traditional Chinese Medicine (TCM) practitioners believe that health can be maintained if the body has a balanced ying-yang or the qi flows in correct strength and quality along the meridians.Stimulation of the acupoints such as by acupuncture can awaken and modulate qi in the channels and is able to regulate and restore yin-yang balance.However, there are some drawbacks associated with acupuncture which may limit its applications. These include transmission of infectious disease, pneumothorax and other problems associated with organ punctures, cardiac tamponade, and broken needles with remnants migrating to other locations.Studies have shown that when TENS is applied over acupoints (Acu-TENS), it is effective in reducing dyspnoea in patients with chronic obstructive pulmonary disease,facilitate early haemodynamic recovery after open-heart surgery,relieve labor pain,increase in blood β-endorphin level,reduce blood pressure changes in normal healthy subjects and decrease airway resistance.Despite these promising results, how Acu-TENS works still remain unclear.This study aimed to investigate the effects of Acu-TENS over Hegu (LI4) and Quichi (LI4) on the autonomic nervous system activities and to investigate whether the subject could experience distinct sensation as deqi.', 'detailedDescription': 'Eligibility criteria: Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese.\n\nOutcome Measures: Heart rate, Mean arterial blood pressure, Heart rate variability'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese were recruited for study\n\nExclusion Criteria:\n\n* history of cardiopulmonary, neurological and psychologic disorders or they required taking drugs within one week that might affect the cardiovascular and neurological status'}, 'identificationModule': {'nctId': 'NCT01804192', 'acronym': 'Acu-TENS', 'briefTitle': 'Is Acupoints Sensation Necessary for Acu-TENS to Elicit Physiological Changes in Healthy Subjects?', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Is Acupoints Sensation Necessary for Acu-TENS to Elicit Physiological Changes in Healthy Subjects?', 'orgStudyIdInfo': {'id': 'HSEARS20080514001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acu-TENS to LI4 and LI11', 'description': 'Acu-TENS Group (Experimental Group), subjects received TENS over right L14 and LI11.\n\nSystolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor. The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device. The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 for data acquisition and analysis of the HRV.', 'interventionNames': ['Other: Acu-TENS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Control Acu-TENS Group (Control Group), subjects received TENS over tips of bilateral knee caps.\n\nSystolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor. The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device. The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 for data acquisition and analysis of the HRV.', 'interventionNames': ['Other: Acu-TENS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo Acu-TENS Group (Placebo Group), subjects received the same protocol as the Acu-TENS group and TENS was applied over right LI4 and LI11 that covered with non-conducting plastics (with the same dimension as the TENS electrodes) Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor. The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device. The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 for data acquisition and analysis of the HRV.', 'interventionNames': ['Other: Acu-TENS']}], 'interventions': [{'name': 'Acu-TENS', 'type': 'OTHER', 'otherNames': ['A dual channel portable TENS unit'], 'description': 'Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 (ADInstruments Pty Ltd. NSW, Australia) for data acquisition and analysis of the HRV.', 'armGroupLabels': ['Acu-TENS to LI4 and LI11', 'Control group', 'Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'state': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'David TW Yu, Master', 'role': 'CONTACT', 'email': 'davidyu03@yahoo.com.hk', 'phone': '852-26986216'}], 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Tai Wai David Yu, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Queen Elizabeth Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Yu Tai Wai David', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}