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NCT00971490 Clinical Trial

Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:
Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00971490
Other study ID # CRE-2007.158-T
Secondary ID
Status Completed
Phase N/A
First received July 28, 2009
Last updated September 2, 2009
Start date August 2007
Est. completion date December 2008

Study information
Verified date September 2009
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• Acu-TENS (Transcutaneous electrical nerve stimulation)
Transcutaneous electrical nerve stimulation applied onto acupuncture point
• Acu-TENS (Transcutaneous electrical nerve stimulation)
Similar to Group 1 but without electrical stimulation
• Acu-TENS (Transcutaneous electrical nerve stimulation)
Similar to Group 1 but applied onto non acupuncture point

Locations
Country Name City State
China Prince of Wales Hospital Shatin, Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) measured before and after the 4-week program
Secondary beta endorphin, St George Respiratory Questionnaire (SGRQ) measured before and after the 4-week program
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