Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000641190
Ethics application status
Approved
Date submitted
5/04/2019
Date registered
30/04/2019
Date last updated
7/07/2020
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Visualisation Affect Pain and Function in people with Achilles Tendinopathy?
Scientific title
Does Visualisation Affect Pain and Function in people with Achilles Tendinopathy (AT)? A randomised crossover trial.
Secondary ID [1] 297756 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles Tendinopathy 312098 0
Condition category
Condition code
Musculoskeletal 310653 310653 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised cross over experiment in which participants will complete a standardised sub maximal hopping task of 10 hops on a portable force plate under two different conditions in random order. Participants will be asked to self pace a series of 10 hops at their own natural hopping frequency. The intervention will be administered by a Physiotherapist. The intervention condition involves hopping while visualizing their calf muscle and Achilles tendon. A live video will be projected to a screen in front of the participant during the hopping trial. Participants will view their calf and Achilles in real time while they hop. An iPad will record the hopping trials and mirror the video to a screen placed in front of the participant. The washout period will be 15 minutes.
Intervention code [1] 313995 0
Rehabilitation
Intervention code [2] 313996 0
Behaviour
Comparator / control treatment
The control condition involves the same submaximal hopping task. Participants will perform 10 hops on a portable force plate while attending to a video screen in front of them. No image will be projected on the screen.
Control group
Active

Outcomes
Primary outcome [1] 319500 0
Pain intensity while hopping measured using the Visual Analogue Scale for Pain (VAS) will be the primary outcome used in this study.
Timepoint [1] 319500 0
Participants will be asked the rate the maximal pain intensity experienced while hopping Immediately on completion of the task
Secondary outcome [1] 368490 0
A leg stiffness estimate while hopping will be calculated using force plate data collected during the trial
Timepoint [1] 368490 0
leg stiffness will be calculated during the hopping task
Secondary outcome [2] 368491 0
Time to ease. After completing each set of single leg hops the participant will be asked to sit and record their time for pain to return to baseline. They will be provided with a timer and instructed to press stop when pain intensity reaches the baseline level.
Timepoint [2] 368491 0
Immediately post testing.

Eligibility
Key inclusion criteria
Participants will be included if they are a recreational runner with a history of unilateral mid portion Achilles tendinopathy for over 1 month. Participants must have sufficient English language skills to complete the questionnaires and be able to give consent to the test procedure. They must have normal to corrected vision so that they can undertake the visual feedback condition. In addition participants VISA-A score must be below 80
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insertional AT will be excluded from this study. People with a non-painful hop test will also be excluded from the study. Participants with a history of foot or ankle injury or surgery within the previous six months or any coexisting lower quadrant musculoskeletal problem will be excluded. Participants with any report of clinically significant low back pain within the previous 3-months will also be excluded. Participants with active systemic disease such as diabetes or an inflammatory disorder and those taking regular analgesic medications will be excluded.

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)
Consecutively numbered sealed opaque envelopes will contain a randomly generated number. Upon completion of recruitment to the study each participant will be assigned a consecutive research number, the envelope corresponding to the participants research number will be opened and those with an even number will complete the visual task first and those with an odd number the no vision task
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will generate a random number sequence for each experiment and then place each number in consecutively numbered sealed opaque envelopes. This sequence will not be done by the principal investigator but another Physiotherapist. The random number sequence generator in excel will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
a generalised linear mixed model will be used to explore the relationship between outcome and condition, including a random effect for participant to account for the correlation between responses from the same person. Order and carryover effects will be investigated.

For this two-arm crossover study a power calculation was used to estimate an 80% probability of detecting a treatment difference at a two sided 0.05 significance level with a minimal detectable difference in mean pain score of 1.5 for this within group study and a standard deviation of the difference between the two value for the same patient of 1.2 based on a previous unpublished work from our group. This estimated a sample size of 8 participants would be required to detect a statistically significant difference between groups. We plan to oversample by 6 in case of missing data and the uncertainty of assumptions giving a final sample size of 14.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/05/2019
Actual
28/05/2019
Date of last participant enrolment
Anticipated
25/05/2020
Actual
19/12/2019
Date of last data collection
Anticipated
25/05/2020
Actual
19/12/2019
Sample size
Target
14
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 26058 0
6005 - West Perth
Recruitment postcode(s) [2] 26059 0
6012 - Mosman Park

Funding & Sponsors
Funding source category [1] 302281 0
University
Name [1] 302281 0
Notre Dame University Fremantle
Country [1] 302281 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia
Address
19 Mouat Street
Fremantle, WA, 6959
Country
Australia
Secondary sponsor category [1] 302320 0
None
Name [1] 302320 0
Address [1] 302320 0
Country [1] 302320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303091 0
The University of Notre Dame Human Research Ethics Committee
Ethics committee address [1] 303091 0
Ethics committee country [1] 303091 0
Australia
Date submitted for ethics approval [1] 303091 0
11/04/2019
Approval date [1] 303091 0
27/05/2019
Ethics approval number [1] 303091 0
019061F

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91974 0
Mr Nigel Travers
Address 91974 0
Nigel Travers
Star Physio
31 Outram Street
West Perth
WA 6005
Country 91974 0
Australia
Phone 91974 0
+61 452605794
Fax 91974 0
Email 91974 0
[email protected]
Contact person for public queries
Name 91975 0
Nigel Travers
Address 91975 0
Nigel Travers
Star Physio
31 Outram Street
West Perth
WA 6005
Country 91975 0
Australia
Phone 91975 0
+61 452605794
Fax 91975 0
Email 91975 0
[email protected]
Contact person for scientific queries
Name 91976 0
Nigel Travers
Address 91976 0
Nigel Travers
Star Physio
31 Outram Street
West Perth
WA 6005
Country 91976 0
Australia
Phone 91976 0
+61 452605794
Fax 91976 0
Email 91976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication with no end date determined.
Available to whom?
This would be on a case-by-case basis at the discretion of Chief Investigators.
Available for what types of analyses?
None specific.
How or where can data be obtained?
Data may be used in future research by the Chief Investigators. If used, the data will be in a de-identified form and no individual data or participant will be identifiable. Data may be shared with other researchers if a formal request for information is made. In these circumstances only coded data will be provided with no identifying code that would allow re-identification of the data, assuring participant anonymity.


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.