Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000867998p
Ethics application status
Submitted, not yet approved
Date submitted
22/06/2020
Date registered
31/08/2020
Date last updated
31/08/2020
Date data sharing statement initially provided
31/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Auditory Information Affect Tendon Pain And Function During Hopping In People With Achilles Tendinopathy?
Scientific title
Does Auditory Information Affect Tendon Pain And Function During Hopping In People With Achilles Tendinopathy (AT)? A randomised crossover trial.
Secondary ID [1] 300029 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles Tendinopathy 315532 0
Condition category
Condition code
Musculoskeletal 313813 313813 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 single leg hops on a portable force plate under 4 different conditions in random order. Participants will be asked to self pace a series of 10 hops at their own natural hopping frequency. Participants will be asked to hop submaximally in bare feet (easy self paced hops) and wear loose sports clothing. The intervention will be administered by a Physiotherapist. No specific training is required to administer the hopping tests or auditory input by the Physiotherapist. The four conditions will be 1) Hopping with no auditory feedback 2) Hopping with auditory input that suggests enhanced functional capacity of the tendon (Spring sound) 3) Hopping with auditory input that suggests impaired functional capacity of the tendon (wet cement sound) and 4)hopping with non-informative auditory input. Speakers will be connected to a laptop and positioned either side of the force plate. For the control condition white noise will be played through the speakers as the participant hops. For the two informative auditory trials the timing of the sound will be matched to their hopping frequency. The washout period will be 15 minutes. Participants will be blinded to the study hypotheses and order will be randomised and counterbalanced across condition. The physiotherapist will use a checklist to adhere to the specific protocol. All records and notes will be checked by a study supervisor. The intervention session will take approximately 1 hour.
Intervention code [1] 316302 0
Rehabilitation
Intervention code [2] 316303 0
Behaviour
Comparator / control treatment
The control conditions involves the same submaximal hopping task with non informative auditory input (white noise).
Control group
Active

Outcomes
Primary outcome [1] 324210 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] 324210 0
Participants will be asked the rate the maximal pain intensity experienced while hopping Immediately on completion of the task.
Secondary outcome [1] 384075 0
A leg stiffness estimate while hopping will be calculated using force plate data collected during the trial
Timepoint [1] 384075 0
leg stiffness will be calculated during the hopping task
Secondary outcome [2] 384076 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] 384076 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 hearing so that they can undertake the auditory feedback conditions. In addition the participants' Victorian Institute of Sports Assessment self-administered Achilles (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
10/09/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 30618 0
6005 - West Perth
Recruitment postcode(s) [2] 30619 0
6012 - Mosman Park

Funding & Sponsors
Funding source category [1] 304481 0
University
Name [1] 304481 0
Notre Dame University Fremantle
Country [1] 304481 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] 304751 0
None
Name [1] 304751 0
Address [1] 304751 0
Country [1] 304751 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304916 0
The University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [1] 304916 0
Ethics committee country [1] 304916 0
Australia
Date submitted for ethics approval [1] 304916 0
09/07/2020
Approval date [1] 304916 0
Ethics approval number [1] 304916 0

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

Contacts
Principal investigator
Name 98630 0
Mr Nigel Travers
Address 98630 0
Nigel Travers
Star Physio
31 Outram Street
West Perth
WA 6005
Country 98630 0
Australia
Phone 98630 0
+61 452605794
Fax 98630 0
Email 98630 0
[email protected]
Contact person for public queries
Name 98631 0
Nigel Travers
Address 98631 0
Nigel Travers
Star Physio
31 Outram Street
West Perth
WA 6005
Country 98631 0
Australia
Phone 98631 0
+61 452605794
Fax 98631 0
Email 98631 0
[email protected]
Contact person for scientific queries
Name 98632 0
Nigel Travers
Address 98632 0
Nigel Travers
Star Physio
31 Outram Street
West Perth
WA 6005
Country 98632 0
Australia
Phone 98632 0
+61 452605794
Fax 98632 0
Email 98632 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]). 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. 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.