NCT00922051

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
Last Updated

June 17, 2009

Status Verified

June 1, 2009

Enrollment Period

6 months

First QC Date

June 16, 2009

Last Update Submit

June 16, 2009

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDFEV1beta endorphinTENSacupuncture

Outcome Measures

Primary Outcomes (1)

  • Forced expiratory flow volume in one second (FEV1), forced vital capacity (FVC)

    measured before and after intervention

Secondary Outcomes (1)

  • Beta endorphin

    before and after intervention

Study Arms (2)

Group 1

EXPERIMENTAL

Application of Acu-TENS

Device: Transcutaneous electrical nerve stimulation (TENS)

Group 2

PLACEBO COMPARATOR
Device: Transcutaneous electrical nerve stimulation (TENS)

Interventions

Transcutaneous electrical nerve stimulation (TENS)DEVICE
Group 1

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis with COPD

You may not qualify if:

  • allergic to gel
  • unable to perform spirometry
  • unable to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Alice Jones, PhD, FACP

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 17, 2009

Study Start

March 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

June 17, 2009

Record last verified: 2009-06

Locations

CN(1)