Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000281695
Ethics application status
Not yet submitted
Date submitted
7/03/2014
Date registered
18/03/2014
Date last updated
18/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture Transcutaneous Electrical Nerve Stimulation (Acu-TENS) for acute exacerbations of Chronic Obstructive Pulmonary Disease(COPD)
Scientific title
Can Acupuncture Transcutaneous Electrical Nerve Stimulation (Acu-TENS) reduce the rate of hospital admission for people with acute exacerbation of chronic obstructive pulmonary disease?
Secondary ID [1] 284179 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute exacerbation chronic obstructive pulmonary disease(AECOPD) 291278 0
Condition category
Condition code
Respiratory 291632 291632 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the Acu-TENS group will get be educated on breathing techniques in management of dyspnoea prior to their discharge.And besides this,they will have two small electrodes placed on the skin on two acupoints (called Ding Chuan) on either side of the spine at the base of the neck (spinal level C7). The points will be identified by an experienced research assistant who is trained in traditional Chinese medicine as well as western medicine, specialized in management of respiratory conditions. The skin over the acupoints will be cleaned with an alcohol swab. TENS electrodes (3M Registered Trademark) will be pressed against the skin at the acupoints. The electrodes wires will then be attached to a TENS unit (ITO320) and a pre-set stimulation protocol (Burst Modulation,Frequency 2Hz,Pulse duration 200 microsec)will be activated. Participants having Acu-TENS should expect to feel a strong but comfortable tingling sensation at the site of the electrodes; it must not be painful. The duration of the stimulation will be 45 minutes in a relaxed sitting position only once.
Intervention code [1] 288878 0
Treatment: Devices
Comparator / control treatment
Participants who are randomized to the control group (no Acu-TENS) will be asked to sit in a relaxed position for 45minutes
Control group
Active

Outcomes
Primary outcome [1] 291562 0
Reduce symptoms of breathlessness in people with COPD presenting to the Emergency Department (ED) of the Gold Coast University Hospital (GCUH)
Baseline heart rate (HR) and oxygen saturation (SpO2) - continuously recorded by a pulse oximeter.
Respiratory rate (RR) will be recorded by observation.
Peak expiratory flow rate (PEFR) will be recorded using a Wright peak flow meter
Timepoint [1] 291562 0
At 45 minutes when Acu-TENS treatment has been completed
Primary outcome [2] 291563 0
Reduce the need for hospital admission
The physician in charge will examine the patient at the end of the 45 minutes. Discharge destination (ward, home) from AED will be recorded.
Timepoint [2] 291563 0
At 45 minutes when Acu-TENS treatment has been completed
Secondary outcome [1] 307081 0
The levels of Beta-endorphin and interleukin-8 (IL-8), tumour necrosis factor-a (TNF-a), and C-reactive protein (CRP) will be measured by Enzyme-Linked Immunosorbent Assay (ELISA)analysis.
Timepoint [1] 307081 0
Baseline,45minutes.

Eligibility
Key inclusion criteria
Participants who have been previously diagnosed with COPD of mild or moderate severity.
Inclusion criteria for enrolment into this study were all adult patients who presented with symptoms of breathlessness and/or wheezing and a self-reported previous history of COPD.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who have a co-existing condition of the heart or lungs other than COPD; or other medical diseases that might require you to be admitted to hospital (for example, unstable diabetes, respiratory failure, cardiac condition etc.).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 288806 0
Government body
Name [1] 288806 0
Physiotherapy Research Fellowships Health and Medical Research (HMR) Funding,Preventive Health Unit, Department of Health Queensland
Country [1] 288806 0
Australia
Primary sponsor type
Individual
Name
Liisa Laakso
Address
School of Allied Health Sciences
Gold Coast Campus,
Griffith University Queensland 4222
Country
Australia
Secondary sponsor category [1] 287502 0
Individual
Name [1] 287502 0
Zhenwei Wang
Address [1] 287502 0
16 Spikes Court, Arundel, Queensland, 4214
Country [1] 287502 0
Australia
Secondary sponsor category [2] 287503 0
Individual
Name [2] 287503 0
Alice Jones
Address [2] 287503 0
School of Allied Health Sciences
Gold Coast Campus,
Griffith University Queensland 4222
Country [2] 287503 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290652 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 290652 0
Level 5, D Block, Room 101
Gold Coast University Hospital
Hospital Boulevard
SOUTHPORT QLD 4215
Ethics committee country [1] 290652 0
Australia
Date submitted for ethics approval [1] 290652 0
12/03/2014
Approval date [1] 290652 0
Ethics approval number [1] 290652 0

Summary
Brief summary
This study will investigate if Acu-TENS is able to reduce symptoms of breathlessness in people with COPD presenting to the Emergency Department (ED) of the Gold Coast University Hospital (GCUH) and if it is enough to reduce the need for hospital admission. We will also try to clarify the brain and nerve system (neurochemical) pathways whereby Acu-TENS relieves breathlessness - this will be assessed by blood samples.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46610 0
A/Prof Liisa Laakso
Address 46610 0
School of Allied Health Sciences
Gold Coast Campus,
Griffith University Queensland 4222
Country 46610 0
Australia
Phone 46610 0
+61 (0) 7 5552 9122
Fax 46610 0
Email 46610 0
l.laakso@griffith.edu.au
Contact person for public queries
Name 46611 0
A/Prof Liisa Laakso
Address 46611 0
School of Allied Health Sciences
Gold Coast Campus,
Griffith University Queensland 4222
Country 46611 0
Australia
Phone 46611 0
+61 (0) 7 5552 9122
Fax 46611 0
Email 46611 0
l.laakso@griffith.edu.au
Contact person for scientific queries
Name 46612 0
A/Prof Liisa Laakso
Address 46612 0
School of Allied Health Sciences
Gold Coast Campus,
Griffith University Queensland 4222
Country 46612 0
Australia
Phone 46612 0
+61 (0) 7 5552 9122
Fax 46612 0
Email 46612 0
l.laakso@griffith.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.