Acute Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Forced Expiratory Flow Volume in One Second (FEV1) and Blood β-Endorphin Level in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS)
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, FEV1, beta endorphin, TENS, acupuncture
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis with COPD
Exclusion Criteria:
- allergic to gel
- unable to perform spirometry
- unable to communicate
Sites / Locations
- West China Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Arm Description
Application of Acu-TENS
Outcomes
Primary Outcome Measures
Forced expiratory flow volume in one second (FEV1), forced vital capacity (FVC)
Secondary Outcome Measures
Beta endorphin
Full Information
NCT ID
NCT00922051
First Posted
June 16, 2009
Last Updated
June 16, 2009
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT00922051
Brief Title
Acute Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Forced Expiratory Flow Volume in One Second (FEV1) and Blood β-Endorphin Level in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Acute Effects of Acu-TENS on FEV1 and Blood β-Endorphin Level in Subjects With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions, dyspnoeic symptoms and its association with beta endorphin level in subjects with COPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, FEV1, beta endorphin, TENS, acupuncture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Application of Acu-TENS
Arm Title
Group 2
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Forced expiratory flow volume in one second (FEV1), forced vital capacity (FVC)
Time Frame
measured before and after intervention
Secondary Outcome Measure Information:
Title
Beta endorphin
Time Frame
before and after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis with COPD
Exclusion Criteria:
allergic to gel
unable to perform spirometry
unable to communicate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Jones, PhD, FACP
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
12. IPD Sharing Statement
Learn more about this trial
Acute Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Forced Expiratory Flow Volume in One Second (FEV1) and Blood β-Endorphin Level in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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