Effects of a 4-week Acu-Transcutaneous Electrical Nerve S... | NCT00971490

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

NCT00971490

Sponsor

The Hong Kong Polytechnic University

Status

Completed

Last Update Posted

Sep 3, 2009Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Acu-TENS (Transcutaneous electrical nerve stimulation)
Acu-TENS (Transcutaneous electrical nerve stimulation)
Acu-TENS (Transcutaneous electrical nerve stimulation)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jul 28, 2009

First Submission Date that Met QC Criteria

Sep 2, 2009

First Posted Date

Sep 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2009

Last Update Posted Date

Sep 3, 2009Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group 1	Experimental	Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Group 2	Placebo Comparator	Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Group 3	Sham Comparator	Device: Acu-TENS (Transcutaneous electrical nerve stimulation)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acu-TENS (Transcutaneous electrical nerve stimulation)	Device	Transcutaneous electrical nerve stimulation applied onto acupuncture point	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC)		measured before and after the 4-week program

Secondary Outcomes

Measure	Description	Time Frame
beta endorphin, St George Respiratory Questionnaire (SGRQ)		measured before and after the 4-week program

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Shatin, Hong Kong			China

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation
D000698	Analgesia
D000760	Anesthesia and Analgesia