Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 28, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedSeptember 3, 2009
September 1, 2009
1.3 years
July 28, 2009
September 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC)
measured before and after the 4-week program
Secondary Outcomes (1)
beta endorphin, St George Respiratory Questionnaire (SGRQ)
measured before and after the 4-week program
Study Arms (3)
Group 1
EXPERIMENTALGroup 2
PLACEBO COMPARATORGroup 3
SHAM COMPARATORInterventions
Transcutaneous electrical nerve stimulation applied onto acupuncture point
Eligibility Criteria
You may qualify if:
- clinical diagnosis with COPD
You may not qualify if:
- allergic to gel
- unable to perform spirometry
- unable to communicate
- no history of infection or exacerbation of respiratory symptoms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Shatin, Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 28, 2009
First Posted
September 3, 2009
Study Start
August 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
September 3, 2009
Record last verified: 2009-09