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

NCT ID: NCT00971490

Last Updated: 2009-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Group Type EXPERIMENTAL

Acu-TENS (Transcutaneous electrical nerve stimulation)

Intervention Type DEVICE

Transcutaneous electrical nerve stimulation applied onto acupuncture point

Group 2

Group Type PLACEBO_COMPARATOR

Acu-TENS (Transcutaneous electrical nerve stimulation)

Intervention Type DEVICE

Similar to Group 1 but without electrical stimulation

Group 3

Group Type SHAM_COMPARATOR

Acu-TENS (Transcutaneous electrical nerve stimulation)

Intervention Type DEVICE

Similar to Group 1 but applied onto non acupuncture point

Interventions

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Acu-TENS (Transcutaneous electrical nerve stimulation)

Transcutaneous electrical nerve stimulation applied onto acupuncture point

Intervention Type DEVICE

Acu-TENS (Transcutaneous electrical nerve stimulation)

Similar to Group 1 but without electrical stimulation

Intervention Type DEVICE

Acu-TENS (Transcutaneous electrical nerve stimulation)

Similar to Group 1 but applied onto non acupuncture point

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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The Hong Kong Polytechnic University

Locations

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Prince of Wales Hospital

Shatin, Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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CRE-2007.158-T

Identifier Type: -

Identifier Source: org_study_id

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