Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000651189
Ethics application status
Approved
Date submitted
5/04/2019
Date registered
1/05/2019
Date last updated
5/02/2021
Date data sharing statement initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does The Explanation of Tendon Sensitivity Affect Pain and Function in people with Achilles Tendinopathy?
Scientific title
Does The Explanation of Tendon Pathology Affect Pain and Function in people with Achilles Tendinopathy?
Secondary ID [1] 297734 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles Tendinopathy 312065 0
Condition category
Condition code
Musculoskeletal 310628 310628 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be given an explanation of their tendon sensitivity that will focus on functional and wholly reversible problems within the musculature of the lower limb that impact on the way the tendon is loaded. The explanation will be delivered by a physiotherapist in a single 5 minute session. The essence of the messaging is that the tendon is sensitive as a consequence of highly reversible functional problems elsewhere – the concept of the tendon as a victim not the culprit. Efforts will be made to ensure that participants are reassured that their tendon is strong and robust and fit for purpose to perform the hopping task without any danger to the tendon structure. The participant will be told that their Achilles tendon is painful due to the leg lacking the capacity to perform the tasks they wanted to do. If they increase the strength of their leg then it is reversible. No other description will be used.
Intervention code [1] 313973 0
Rehabilitation
Intervention code [2] 313974 0
Behaviour
Comparator / control treatment
In the usual care intervention participants will be given an explanation commonly used in clinical practice, this involves a description of the continuum of tendinopathy and an explanation of their pain in terms of tendon pathology. The explanation will be delivered by a physiotherapist in a single 10 minute session. They will use a series of 4 pictures of UTC scans of an Achilles tendon. The essence of the messaging is that the tendon is sensitive because of structural alterations within the tendon. A series of ultrasound tissue characterisation (UTC) scan images of an Achilles tendon will be used to visualise the stages of tendinopathy from an acute reactive phase to a chronic degenerative tendon and the phase that corresponds to the participant’s current time line will be pointed out.
Control group
Active

Outcomes
Primary outcome [1] 319475 0
Pain intensity during hopping measured using the Visual Analogue Scale for Pain (VAS) will be the primary outcome used in this study.
Timepoint [1] 319475 0
Participants will report on the maximal pain experienced during the hopping procedure undertaken immediatley after recieving the educational intervention
Secondary outcome [1] 368320 0
Leg stiffness while hopping will be calculated using data from a portable force plate.
Timepoint [1] 368320 0
leg stiffness will be assessed during the hopping procedure undertaken immediatley after recieving the educational intervention
Secondary outcome [2] 368321 0
Time to ease. After completing the post intervention hopping task 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] 368321 0
Immediately post intervention.

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. 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. On completion of recruitment participants will be assigned a consecutive research number and the envelope corresponding to their research number will be opened. Odd/even number allocation will be used to assign participants to the either the active or control intervention.
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming a minimal detectable difference in mean pain score of 1.5 for this between group study and a standard deviation of 1.9 for the VAS Pain measure based on a previous unpublished work from our group, 54 people (n=27 per group) are required to detect this difference with a power of 0.8 at the alpha=0.05 level. To adjust this sample size for analysis of covariance, we assumed the correlation between pre and post VAS scores is 0.8 and applied the adjustment factor 1-r^2 to the sample size calculated for the between groups t-test. This resulted in a sample size of 19. We plan to oversample by 6 in case of missing data and the uncertainty of assumptions giving a final sample size of 25

differences between groups will be tested using analysis of covariance controlling for baseline scores. Linear contrasts will be constructed to compare the adjusted mean change in outcome from pre to post between the two interventions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/08/2020
Actual
3/08/2020
Date of last participant enrolment
Anticipated
1/03/2021
Actual
Date of last data collection
Anticipated
1/03/2021
Actual
Sample size
Target
25
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 26027 0
6005 - West Perth
Recruitment postcode(s) [2] 26028 0
6012 - Mosman Park

Funding & Sponsors
Funding source category [1] 302261 0
University
Name [1] 302261 0
Notre Dame University Fremantle
Country [1] 302261 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] 302125 0
None
Name [1] 302125 0
None
Address [1] 302125 0
None
Country [1] 302125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302937 0
The University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [1] 302937 0
19 Mouat Street
Fremantle, WA 6959
Ethics committee country [1] 302937 0
Australia
Date submitted for ethics approval [1] 302937 0
11/04/2019
Approval date [1] 302937 0
27/05/2019
Ethics approval number [1] 302937 0
Reference Number: 019061F

Summary
Brief summary

Contemporary thinking suggest that pain may be enhanced by the messages that health practitioners convey to patients in their initial meeting as they have been shown to have a strong influence upon their prior beliefs . Despite there being a very weak relationship between observable tissue pathology and symptoms research suggests that clinicians commonly use tissue based structural descriptions to explain clinical status in people with persistent musculoskeletal pain problems . The aim of this study therefore is to examine the instantaneous effect of diagnostic messaging on pain and function in people with AT. To achieve this, we will assess pain and leg stiffness with hopping in people with AT before and after a standard diagnostic discussion that includes discussion of tendon pathology and compare these results with participants who receive a diagnostic explanation that does not reference tendon pathology.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91906 0
Mr Nigel Travers
Address 91906 0
Star Physiotherapy
31 Outram Street
West Perth
WA 6005
Country 91906 0
Australia
Phone 91906 0
+61 452605794
Fax 91906 0
Email 91906 0
[email protected]
Contact person for public queries
Name 91907 0
Mr Nigel Travers
Address 91907 0
Star Physiotherapy
31 Outram Street
West Perth
WA 6005
Country 91907 0
Australia
Phone 91907 0
+61 452605794
Fax 91907 0
Email 91907 0
[email protected]
Contact person for scientific queries
Name 91908 0
Mr Nigel Travers
Address 91908 0
Star Physiotherapy
31 Outram Street
West Perth
WA 6005
Country 91908 0
Australia
Phone 91908 0
+61 452605794
Fax 91908 0
Email 91908 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?


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.