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:
Information provided by:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT00971490
First received: July 28, 2009
Last updated: September 2, 2009
Last verified: September 2009
  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: Double Blind (Subject, Caregiver, 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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971490

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

No publications provided

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
Study First Received: July 28, 2009
Last Updated: September 2, 2009
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 29, 2014