Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000749909p
Ethics application status
Submitted, not yet approved
Date submitted
8/06/2020
Date registered
21/07/2020
Date last updated
21/07/2020
Date data sharing statement initially provided
21/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does The Visual Appearance Of The Tendon Effect Pain and Function During Hopping In People With Achilles Tendinopathy (AT)?
Scientific title
Does The Visual Appearance Of The Tendon Effect Pain and Function During Hopping In People With Achilles Tendinopathy (AT)? A randomised crossover trial.
Secondary ID [1] 300022 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles Tendinopathy 315522 0
Condition category
Condition code
Musculoskeletal 313804 313804 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. All participants will be randomly allocated to both interventions and the control condition. Participants will need to have Victorian Institute of Sports Assessment self-administered Achilles (VISA-A) score below 80 and a painful hop test. 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. One intervention condition involves hopping while visualizing their calf muscle and Achilles tendon with red body paint applied to the tendon. The other intervention condition involves hopping while visualizing their calf muscle and Achilles tendon with blue body paint applied to the 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] 316293 0
Rehabilitation
Intervention code [2] 316294 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. Clear body paint will be applied to the tendon
Control group
Active

Outcomes
Primary outcome [1] 322210 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] 322210 0
Participants will be asked the rate the maximal pain intensity experienced while hopping Immediately on completion of the task.
Secondary outcome [1] 377743 0
A leg stiffness estimate while hopping will be calculated using force plate data collected during the trial
Timepoint [1] 377743 0
leg stiffness will be calculated during the hopping task
Secondary outcome [2] 377744 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] 377744 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2020
Actual
Date of last participant enrolment
Anticipated
1/11/2020
Actual
Date of last data collection
Anticipated
1/11/2020
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 28744 0
6005 - West Perth
Recruitment postcode(s) [2] 28745 0
6012 - Mosman Park

Funding & Sponsors
Funding source category [1] 304476 0
University
Name [1] 304476 0
Notre Dame University Fremantle
Country [1] 304476 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia
Address
32 Mouat Street
Fremantle
WA 6160
Country
Australia
Secondary sponsor category [1] 304745 0
None
Name [1] 304745 0
Address [1] 304745 0
Country [1] 304745 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304907 0
The University of Notre Dame Human Research Ethics Committee
Ethics committee address [1] 304907 0
The University of Notre Dame Australia 19 Mouat Street Fremantle, WA 6959
Ethics committee country [1] 304907 0
Australia
Date submitted for ethics approval [1] 304907 0
09/07/2020
Approval date [1] 304907 0
Ethics approval number [1] 304907 0

Summary
Brief summary
The perception of health of the body and the estimation of the capacity of the body is informed by visual information from the body. It has been shown that creating the visual illusion of a muscled and fit looking back increased the participants feeling of strength and confidence in the back. This seems to also affect the pain experience. Pain during a lifting task was dramatically less when viewing an embodied image of a strong back than when viewing a normal image of the back .We have demonstrated a similar phenomenon with exercise induced muscle pain. Participants rated their pain as greater when viewing a magnified image of the thigh during contraction of the injured thigh muscles compared with viewing the thigh normally. We interpreted this as the magnified image suggesting a more swollen and therefore more injured muscle. We wish to see if other visual information than suggests a more sensitised structure similarly influences pain intensity without the confounding effect of visual distortion, particularly in clinical pain. Other researchers have shown that changing the colour of the body part changed sensitivity in an experimental pain model. Making the body part appear red, suggesting inflamed tissue, increased sensitivity whereas making the part appear blue had no effect on sensitivity. We hope to explore this phenomenon to see if, and to what extent, it exists in AT, and to simultaneously investigate the effect of this type of visual information on tendon function – something which no study of visually manipulation has done before. The aim of this study is therefore to examine the effect of augmented visualisation on pain and function in people with AT. To achieve this, we will assess pain and leg stiffness with hopping in people with AT while they view a video image of their leg under normal conditions and compare these results with an augmented vision condition in which the tendon is painted red. To control for the confounding effect of a change in tendon colour we will have an additional control condition in which the tendon is painted blue.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98610 0
Mr Nigel Travers
Address 98610 0
Star Physio
31 Outram Street
West Perth
WA 6005
Country 98610 0
Australia
Phone 98610 0
+61 452605794
Fax 98610 0
Email 98610 0
[email protected]
Contact person for public queries
Name 98611 0
Mr Nigel Travers
Address 98611 0
Star Physio
31 Outram Street
West Perth
WA 6005
Country 98611 0
Australia
Phone 98611 0
+61 452605794
Fax 98611 0
Email 98611 0
[email protected]
Contact person for scientific queries
Name 98612 0
Mr Nigel Travers
Address 98612 0
Star Physio
31 Outram Street
West Perth
WA 6005
Country 98612 0
Australia
Phone 98612 0
+61 452605794
Fax 98612 0
Email 98612 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?
Non Specific
How or where can data be obtained?
Data may be used in future research by the Chief Investigators ([email protected]). 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. Only coded data will be provided with no identifying code that would allow re-identification of the data.


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.