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Acute Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Forced Expiratory Flow Volume in One Second (FEV1) and Blood β-Endorphin Level in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00922051
First Posted: June 17, 2009
Last Update Posted: June 17, 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 objective of this study is to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions, dyspnoeic symptoms and its association with beta endorphin level in subjects with COPD.

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

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: Acute Effects of Acu-TENS on FEV1 and Blood β-Endorphin Level in Subjects With COPD

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

Primary Outcome Measures:
  • Forced expiratory flow volume in one second (FEV1), forced vital capacity (FVC) [ Time Frame: measured before and after intervention ]

Secondary Outcome Measures:
  • Beta endorphin [ Time Frame: before and after intervention ]

Enrollment: 44
Study Start Date: March 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Application of Acu-TENS
Device: Transcutaneous electrical nerve stimulation (TENS)
Placebo Comparator: Group 2 Device: Transcutaneous electrical nerve stimulation (TENS)
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 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
  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): NCT00922051


Locations
China, Sichuan
West China Hospital
Chengdu, Sichuan, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Alice Jones, PhD, FACP The Hong Kong Polytechnic University
  More Information

Responsible Party: Prof. Alice Jones, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00922051     History of Changes
Other Study ID Numbers: HSEARS20070305001
First Submitted: June 16, 2009
First Posted: June 17, 2009
Last Update Posted: June 17, 2009
Last Verified: June 2009

Keywords provided by The Hong Kong Polytechnic University:
COPD
FEV1
beta endorphin
TENS
acupuncture

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Endorphins
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs