Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acu-TENS (Transcutaneous electrical nerve stimulation)
Acu-TENS (Transcutaneous electrical nerve stimulation)
Acu-TENS (Transcutaneous electrical nerve stimulation)
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, SGRQ, Acu-TENS
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis with COPD
Exclusion Criteria:
- allergic to gel
- unable to perform spirometry
- unable to communicate
- no history of infection or exacerbation of respiratory symptoms
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Sham Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
Outcomes
Primary Outcome Measures
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC)
Secondary Outcome Measures
beta endorphin, St George Respiratory Questionnaire (SGRQ)
Full Information
NCT ID
NCT00971490
First Posted
July 28, 2009
Last Updated
September 2, 2009
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT00971490
Brief Title
Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
5. Study Description
Brief Summary
The objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions and quality of life and to explore the associated underlying mechanisms 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, SGRQ, Acu-TENS
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Title
Group 3
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Acu-TENS (Transcutaneous electrical nerve stimulation)
Intervention Description
Transcutaneous electrical nerve stimulation applied onto acupuncture point
Intervention Type
Device
Intervention Name(s)
Acu-TENS (Transcutaneous electrical nerve stimulation)
Intervention Description
Similar to Group 1 but without electrical stimulation
Intervention Type
Device
Intervention Name(s)
Acu-TENS (Transcutaneous electrical nerve stimulation)
Intervention Description
Similar to Group 1 but applied onto non acupuncture point
Primary Outcome Measure Information:
Title
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC)
Time Frame
measured before and after the 4-week program
Secondary Outcome Measure Information:
Title
beta endorphin, St George Respiratory Questionnaire (SGRQ)
Time Frame
measured before and after the 4-week program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 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
no history of infection or exacerbation of respiratory symptoms
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin, Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)
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