Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000705886
Ethics application status
Approved
Date submitted
29/06/2012
Date registered
3/07/2012
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of application of Transcutaneous Electrical Nerve Stimulation on acupuncture points (Acu-TENS) on lung function in people with asthma
Scientific title
Effect of application of Transcutaneous Electrical Nerve Stimulation on acupuncture points (Acu-TENS) on lung function in people with asthma
Secondary ID [1] 280757 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 286800 0
Condition category
Condition code
Respiratory 287108 287108 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised crossover study.

Participants will attend for 4 visits, weekly apart. In the first visit, participants characteristics will be measured and they will perform a Eucapnic voluntary hyperventilation (EVH) test.
On visits 2 to 4, participants will receive one the following interventions, in a random order, before undergoing the EVH test:
1) Acu-TENS and placebo ventolin
2) Placebo-TENS and placebo ventolin
3) Placebo-TENS and ventolin

Intervention:
Acu-TENS refers to the application of Transcutaneous electrical nerve stimulation (TENS) onto acupoints for reducing breathlessness, i.e. EX-B1, Dingchuan, located on the lower border of 7th Cervical Vertebrae. The intervention will last for 45 minutes. Ten minutes before the end of the Acu-TENS session, participants will receive 2 puffs of placebo-ventolin.

Placebo TENS is similar to Acu-TENS with the application of the TENS onto EX-B1 except the machine was disconnected inside such that there is no electrical output despite the machine screen is still activated. Placebo TENS will be applied for 45 minutes. Ten minutes before the end of the intervention, participants will be asked to use 2 puffs of ventolin or placebo-ventolin (depending on the group allocation).
Intervention code [1] 285175 0
Treatment: Devices
Intervention code [2] 285176 0
Treatment: Drugs
Comparator / control treatment
Placebo TENS: similar to Acu-TENS but the machine was disconnected with no electrical output.

Placebo-ventolin
Control group
Placebo

Outcomes
Primary outcome [1] 287430 0
Percentage change in Forced expirtory flow volume in one second (FEV1)
Timepoint [1] 287430 0
1) Pre EVH test
2) 1st min post EVH test
3) 3rd min post EVH test
4) 5th min post EVH test
5) 10th min post EVH test
6) 15th min post EVH test
7) 20th min post EVH test
Secondary outcome [1] 298130 0
Nil
Timepoint [1] 298130 0
nil

Eligibility
Key inclusion criteria
Patients diagnosed with asthma, with FEV1 % predicted >75%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent upper respiratory tract infection 4 weeks prior to the test.

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)
Patients with asthma who are registered as volunteers for research will be contacted. The intervention sequence will be run by a randomisation software and the order of the intervention will be consealed in a opaque envelop by an investigator not involved in data collection. The actual or circuit disconnected machine and the ventolin or placebo ventolin will be given by an investigator who is not involved in data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The intervention sequence will be generated by a ranomisation software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285535 0
University
Name [1] 285535 0
The University of Sydney
Country [1] 285535 0
Australia
Primary sponsor type
Individual
Name
A/Prof Jennifer Alison
Address
Discipline of Physiotherapy, University of Sydney
75 East Street, Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 284376 0
None
Name [1] 284376 0
Address [1] 284376 0
Country [1] 284376 0
Other collaborator category [1] 276890 0
Individual
Name [1] 276890 0
Dr. Shirley Ngai
Address [1] 276890 0
Department of Rehabilitation Sciences,
The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country [1] 276890 0
Hong Kong
Other collaborator category [2] 276891 0
Individual
Name [2] 276891 0
Prof Alice Jones
Address [2] 276891 0
Department of Rehabilitation Sciences,
The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country [2] 276891 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287556 0
Ethics Review Committee (RPAH Zone), Sydney
Ethics committee address [1] 287556 0
Research Development Office, Royal Prince
Alfred Hospital, Camperdown, Missenden Road, NSW 2050
Ethics committee country [1] 287556 0
Australia
Date submitted for ethics approval [1] 287556 0
29/09/2011
Approval date [1] 287556 0
17/10/2011
Ethics approval number [1] 287556 0
11/RPAH/442

Summary
Brief summary
Increased ventilation during exercise has been proposed to induce osmotic (Hallstrand et al., 2005) and thermal (Tan and Spector, 2002) changes in the airways during and after exercise, resulting in airway narrowing in susceptible people with asthma. Previous study showed that Acu-TENS could alleviate the post exericse bronchoconstriction in people with asthma (Ngai et al., 2009). Thus, the main aim of this study is to evaluate the effectiveness of Acu-TENS, when compared with ventolin, on alleviating the level of bronchoconstriction after Eucapnic voluntary hyperventilation (EVH), a diagnostic test for exercise induced bronchoconstriction. People with asthma who meet the inclusion and exclusion criteria will be recruited. After informed consent, each participant will attend 4 visits to the laboratory. On each visit, participants will perform one EVH test. On the second to fourth visit, participants will receive one of the following intervention protocols: 1) Acu-TENS and placebo ventolin, 2) Placebo-TENS and placebo ventolin; 3) Placebo-TENS and ventolin, in a random order generated by a computer randomisation software, before the EVH test. The intervention will be applied by an investigator who is not involved in data collection. Both assessor and patients will be blinded to the intervention protocol. The change in FEV1 before and after EVH test obtained in each of the 4 visits will be compared. The findings of the study will elucidate whether or not Acu-TENS could alleviate exercise induced bronchoconstriction when compared with ventolin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34373 0
Address 34373 0
Country 34373 0
Phone 34373 0
Fax 34373 0
Email 34373 0
Contact person for public queries
Name 17620 0
A/ Prof Jennifer Alison
Address 17620 0
Discipline of Physiotherapy, Faculty of Health
Sciences, The University of Sydney,
75 East Street, Lidcombe, NSW 2141
Country 17620 0
Australia
Phone 17620 0
+61 2 93519371
Fax 17620 0
+61 2 93519601
Email 17620 0
[email protected]
Contact person for scientific queries
Name 8548 0
A/ Prof Jennifer Alison
Address 8548 0
Discipline of Physiotherapy, Faculty of Health
Sciences, The University of Sydney,
75 East Street, Lidcombe, NSW 2141
Country 8548 0
Australia
Phone 8548 0
+61 2 93519371
Fax 8548 0
+61 2 93519601
Email 8548 0
[email protected]

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
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