Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001143213
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
12/07/2018
Date last updated
13/06/2019
Date data sharing statement initially provided
13/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of transcutaneous electrical nerve stimulation (TENS) therapy on walking performance in patients with peripheral arterial disease
Scientific title
Effect of TENS on walking performance in patients with peripheral arterial disease
Secondary ID [1] 294990 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral artery disease 308626 0
Intermittent claudication 308627 0
Condition category
Condition code
Cardiovascular 307576 307576 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of transcutaneous electrical nerve stimulation (TENS, ~120Hz & 180µs) to PAD-affected lower limb (ie gastrocnemius) of patient prior to (20-minutes) and during the entire 6-minute wallking test by an accredited exercise physiologist.
Application of transcutaneous electrical nerve stimulation (TENS) unit that does not work (Sham) to PAD-affected lower limb (ie gastrocnemius) of patient prior to (20-minutes) and during the entire 6-minute wallking test by an accredited exercise physiologist.
Sessions separated by approximately 7 days each.
Intervention code [1] 301707 0
Treatment: Other
Comparator / control treatment
Patients complete all 3 sessions (treatment, control and sham) with sessions approximately 7 days apart.
Control condition = absence of transcutaneous electrical nerve stimulation (Control) during 6-minute walking test.
Sham condition = application of transcutaneous electrical nerve stimulation unit that has been internally altered to not work (Sham) to the lower limbs during 6-minute walking test.
Control group
Placebo

Outcomes
Primary outcome [1] 306551 0
Total distance walked (to nearest 10cm using tape measure) over a marked walking course during a 6-minute walk test timed by stopwatch.
Timepoint [1] 306551 0
Completed during the walking test at the end of each session.
Secondary outcome [1] 348850 0
Total distance walked (to nearest 10cm using tape measure) over a marked walking course until onset of leg pain (ie pain of 1 on claudication pain VAS) during a 6-minute walk test timed by stopwatch.
Timepoint [1] 348850 0
Completed during the walking test at the end of each session.

Eligibility
Key inclusion criteria
- clinical diagnosis of PAD by general practitioner (GP) or vascular specialist
- history of intermittent claudication.
- ankle-brachial index of <0.9;
- free of any lower limb condition/s that severely limits their walking ability
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- unstable cardiovascular or respiratory conditions that contradict safe performance of exercise (ie 6-minute walking 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)
Order of treatment/sham during sessions 2 and 3 determined by central randomisation via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Patients attend 3 sessions, each consisting of a 6-minute walk test: 1) walking with no TENS (control); 2) walking with TENS; 3) walking with TENS that does not work (sham). Order of intervention during sessions 2 and 3 will be randomised.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based upon prior results of a >89% increase in total treadmill walking capacity (i.e. 5 bouts of walking to initial pain) following pre-walking, acute TENS compared to control (power of 90%, p<0.05) (Labrunée et al., 2015), the minimum sample size will be 17 patients. Subsequently, 20 patients will be recruited for this study to account for potential drop-outs.

All outcome measures will be recorded, reviewed for outliers/missing values and checked for normality via a Kolgmorov Smirnov test with Lillefore’s correction. Normally distributed data will be compared between conditions via 1-way ANOVAs and post-hoc LSD tests. Non-normal distributed and/or categorical data will be compared between conditions via Friedman’s tests and Conover’s post-hoc comparisons.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
23/07/2018
Actual
23/07/2018
Date of last participant enrolment
Anticipated
1/07/2019
Actual
30/09/2018
Date of last data collection
Anticipated
1/07/2019
Actual
30/09/2018
Sample size
Target
20
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 23195 0
4810 - Townsville

Funding & Sponsors
Funding source category [1] 299576 0
University
Name [1] 299576 0
James Cook University
Country [1] 299576 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Drive
Townsville QLD 4811
Country
Australia
Secondary sponsor category [1] 298890 0
None
Name [1] 298890 0
Address [1] 298890 0
Country [1] 298890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300478 0
James Cook University Human Research Ethics Committee [EC00164]
Ethics committee address [1] 300478 0
1 James Cook Drive
Townsville QLD 4811
Ethics committee country [1] 300478 0
Australia
Date submitted for ethics approval [1] 300478 0
01/05/2018
Approval date [1] 300478 0
19/06/2018
Ethics approval number [1] 300478 0
H7398

Summary
Brief summary
Transcutaneous electrical nerve stimulation (TENS) is recognised as a safe, effective and non-invasive method of pain relief that works via stimulation of sensory fibres. Several studies have identified that TENS can significantly reduce exercise induced pain. Given that exercise-induced leg pain is a major barrier to physical activity for patients with peripheral artery diease and intermittent claudication (PAD-IC), further investigation of the benefits of TENS application for these patients could identify a simple therapy to reduce the pain associated with physical activity.

The aim of this project is to examine the influence of TENS on walking capacity (via 6-minute walking test) in PAD-IC patients. Identification of a simple therapy to increase walking capacity will enhance patient mobility and independence that may contribute to improved levels of physical activity, quality of life and subsequent physical health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83782 0
Miss Darci Cousins
Address 83782 0
Sport and Exercise Science
James Cook Unviersity
1 James Cook Drive
Townsville QLD 4811
Country 83782 0
Australia
Phone 83782 0
+61 7 47814576
Fax 83782 0
Email 83782 0
darci.cousins@my.jcu.edu.au
Contact person for public queries
Name 83783 0
Miss Darci Cousins
Address 83783 0
Sport and Exercise Science
James Cook Unviersity
1 James Cook Drive
Townsville QLD 4811
Country 83783 0
Australia
Phone 83783 0
+61 7 47814576
Fax 83783 0
Email 83783 0
darci.cousins@my.jcu.edu.au
Contact person for scientific queries
Name 83784 0
A/Prof Anthony Leicht
Address 83784 0
Sport and Exercise Science
James Cook Unviersity
1 James Cook Drive
Townsville QLD 4811
Country 83784 0
Australia
Phone 83784 0
+61 7 47814576
Fax 83784 0
Email 83784 0
Anthony.Leicht@jcu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Lack of participants


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.