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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971490
First Posted: September 3, 2009
Last Update Posted: September 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Hong Kong Polytechnic University
  Purpose
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.

Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD) Device: Acu-TENS (Transcutaneous electrical nerve stimulation)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) [ Time Frame: measured before and after the 4-week program ]

Secondary Outcome Measures:
  • beta endorphin, St George Respiratory Questionnaire (SGRQ) [ Time Frame: measured before and after the 4-week program ]

Enrollment: 30
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Transcutaneous electrical nerve stimulation applied onto acupuncture point
Placebo Comparator: Group 2 Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Similar to Group 1 but without electrical stimulation
Sham Comparator: Group 3 Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Similar to Group 1 but applied onto non acupuncture point

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00971490


Locations
China
Prince of Wales Hospital
Shatin, Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
  More Information

Responsible Party: Prof. Alice Jones, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00971490     History of Changes
Other Study ID Numbers: CRE-2007.158-T
First Submitted: July 28, 2009
First Posted: September 3, 2009
Last Update Posted: September 3, 2009
Last Verified: September 2009

Keywords provided by The Hong Kong Polytechnic University:
COPD
FEV1
beta endorphin
SGRQ
Acu-TENS

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases