Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000097246
Ethics application status
Approved
Date submitted
16/01/2018
Date registered
22/01/2018
Date last updated
29/03/2019
Date data sharing statement initially provided
29/03/2019
Date results provided
29/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of imaging reports on patient perceptions of treatment in patients with Achilles tendinopathy
Scientific title
The effect of imaging reports on patients perception of treatment efficacy in patients with midsubstance Achilles tendinopathy: A randomised clinical trial
Secondary ID [1] 293657 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record
ACTRN12617001225303: The effectiveness of heel lifts versus calf muscle eccentric exercise for Achilles tendinopathy: a randomised controlled trial

Health condition
Health condition(s) or problem(s) studied:
Midsubstance Achilles tendinopathy 305944 0
Condition category
Condition code
Musculoskeletal 305138 305138 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Evidence-based imaging report: Four weeks following participation in the linked 12 week RCT (heel lift or eccentric exercise) for midsubstance Achilles tendinopathy, this study will send participants a report via email summarising the ultrasound imaging findings from their scans undertaken at the end of the 12 week trial.
The evidence-based imaging group will receive a report 4 weeks after the end of the linked trial, that places their imaging findings in a context of what is within normal appearances for their age and activity. The evidence-based imaging report will be on a standardised report template that places the context of current research evidence. It will outline the following parameters:
-While their tendon is pathological, 30% of the population have a similar looking tendon yet have never had pain.
-State the dimensions (mm2) of aligned fibrillar structure (ie healthy tendon) in comparison to structurally normal tendon
-State maximum tendon thickness in comparison to a structurally normal Achilles tendon, suggesting that is has compensated for the area of disorganisation
-Include a transverse and sagittal image of their Achilles tendon in comparison to a structurally normal tendon

Both groups will receive a one-on-one interview 4 weeks after receiving the imaging report with investigators (experienced researcher with a PhD who specialises in tendon imaging), where their imaging findings will be explained in the context of current research. This consultation will last between 15 and 30mins. The following concepts will be explained to participants in both groups:
-Up to 30% of pain-free individuals have a pathological tendon similar to theirs.
-The presence of pathology is not the reason they had pain, nor is it the reason that they may still have pain.
-The amount of disorganisation (ie the hypoechoic area) is not a barrier to clinical improvement. No measure on imaging has been show to be prognostic for clinical improvements following treatment
-While their tendon has remained pathological, it does not need to remodel to result in clinical improvements following treatment. Their tendon has found its 'happy place' where it is able to tolerate load with this amount of disorganisation and does not need to remodel to normal
-A thick tendon is a good tendon. That the thickened tendon indicates that it has adapted to compensate for the area of disorganisation.
Intervention code [1] 299943 0
Behaviour
Comparator / control treatment
Standard imaging reporting: Four weeks following participation in the linked 12 week intervention program (heel lift or eccentric exercise) for midsubstance Achilles tendinopathy, participants will receive a report via email summarising the ultrasound imaging findings from their scan at the end of the 12 week trial. A standardised report template based on conventional imaging reporting will be used to summarise their imaging findings. It will outline the following parameters:

-That the Achilles tendon has remained pathological
-State the dimensions of the hypoechoic area (antero-posterior diameter, medial-lateral diameter, and length in sagittal plane) as an area of disorganisation
-State maximum tendon thickness in comparison to a structurally normal Achilles tendon
-Include a transverse and sagittal image of their Achilles tendon in comparison to a structurally normal tendon

Both groups will receive a one-on-one interview 4 weeks after receiving the imaging report with investigators (experienced researcher with a PhD who specialises in tendon imaging), where there imaging findings will be explained in the context of current research. This consultation will last between 15 and 30mins. The following concepts will be explained to the patient.

-Up to 30% of pain-free individuals have a pathological tendon similar to theirs.
-The presence of pathology is not the reason they had pain, nor is it the reason that they may still have pain.
-The amount of disorganisation (ie the hypoechoic area) is not a barrier to clinical improvement. No measure on imaging has been show to be prognostic for clinical improvements following treatment
-While their tendon has remained pathological, it does not need to remodel to result in clinical improvements following treatment. Their tendon has found its 'happy place' where it is able to tolerate load with this amount of disorganisation and does not need to remodel to normal
-A thick tendon is a good tendon. That the thickened tendon indicates that it has adapted to compensate for the area of disorganisation.
Control group
Active

Outcomes
Primary outcome [1] 304330 0
Patient global impression of change (PGIC) 7-point likert scale for pain. The scale will ask participants 'compared to how you were before started the treatment (either eccentric loading or heel lifts), how is your pain in your Achilles tendon(s)?' and include the following responses 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', or 'very much worse'.
Timepoint [1] 304330 0
Baseline (at the end of the 12 week exercise and heel raise intervention), 4 weeks (primary timepoint), and 8 weeks.
Primary outcome [2] 304331 0
The patients level of fear of movement will be evaluated using the English version of Tampa scale of kinesiophobia. This questionnaire contains 11 items, where patients answers whether they agree or disagree with the statement on a 4-point Likert scale. A score ranging from 11-44 is calculated, where a high score indicates a high level of kinespiophobia
Timepoint [2] 304331 0
Baseline (at the end of the 12 week exercise and heel raise intervention), 4 weeks (primary timepoint), and 8 weeks
Secondary outcome [1] 341608 0
The Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A) is a standardised measure for Achilles tendinopathy and will be used to assess pain, function, and physical activity. It includes 8 questions, questions 1-6 use a 0-10 numerical rating scale, where questions 7-8 are multiple-choice. A total score out of 100 is calculated, with a low score indicating high level of pain and dysfunction.
Timepoint [1] 341608 0
Baseline (at the end of the 12 week exercise and heel raise intervention), 4 weeks, and 8 weeks
Secondary outcome [2] 341609 0
Severity of pain at the Achilles tendon will be measured using a 100 mm VAS, where participants will be asked ‘Please mark on the line the severity of pain you have experienced in your Achilles tendon(s) when it has been at its worst, over the past week’. The VAS will have the following anchors: zero (0) indicated 'no pain' and one hundred (100) indicates 'worst pain imaginable'.
Timepoint [2] 341609 0
Baseline (at the end of the 12 week exercise and heel raise intervention), 4 weeks, and 8 weeks

Eligibility
Key inclusion criteria
The key inclusion criteria for this study is participation and completion in the registered RCT "The effectiveness of heel lifts versus calf muscle eccentric exercise for Achilles tendinopathy: a randomised controlled trial" (ACTRN12617001225303)

The inclusion criteria for this linked study were:
(a) Aged 18 years or greater.
(b) Achilles tendon pain present in one or both lower limb(s) for a minimum of 2 months.
(c) Report having average daily pain during the past week rated at least 3 out of 10 on a numerical rating scale.
(d) Mid-portion Achilles tendinopathy in one or both lower limb(s). Mid-portion Achilles tendinopathy will be diagnosed based on a clinical assessment and musculoskeletal ultrasound.
Respondents will be included in this study if they meet the following criteria:
(i) insidious onset of pain in the region of the Achilles tendon, aggravated by weight bearing activity;
(ii) pain located 2 to 6 cm proximal to the Achilles tendon insertion upon palpation by the investigator;
(iii) musculoskeletal ultrasound of the Achilles tendon showing local thickening, irregular fibre orientation or hypoechoic areas;
(iv) Literate in English and able to complete the questionnaires used in this study (such as the primary outcome measure - Victorian Institute of Sport Assessment – Achilles (VISA-A) questionnaire).
(v) Regularly use footwear that can accommodate a heel lift of 12 mm height.
(vi) Able to walk household distances (more than 50 m) without the aid of a walker, crutches or cane.
(vii) Willing to attempt to not receive additional treatments (such as shoe modifications, physiotherapy, foot orthoses/bracing, injections, or surgery) for the Achilles pain during the course of the study (12 weeks).
(viii) Willing to attempt to discontinue taking all pain-relieving medications to relieve pain for the Achilles tendon(s) (except paracetamol) for at least 14 days prior to the initial assessment and during the study period (12 weeks).
(ix) Willing to attend the Health Sciences Clinic at La Trobe University (Melbourne, Victoria) for an assessment on three occasions and complete and complete and return a postal questionnaire on one occasion.

The additional key inclusion criteria for this current study being registered are:
(a) musculoskeletal ultrasound of the Achilles tendon showing local thickening, irregular fibre orientation or hypoechoic areas at the end of the intervention.
(b) Willing to attend the Health Sciences Clinic at La Trobe University (Melbourne, Victoria) for an assessment on one occasion, and return a postal/electronic questionnaire on one occasion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for participants in linked study were:
(i) Currently pregnant.
(ii) Previous Achilles tendon surgery in the symptomatic lower limb(s).
(iii) Previous Achilles tendon rupture in the symptomatic lower limb(s).
(iv) Chronic ankle instability.
(v) Conditions of the Achilles tendon / ankle region that are not mid-portion Achilles tendinopathy such as ankle osteoarthritis, impingement syndrome, insertional Achilles tendinopathy, Achilles paratenonitis.
(vi) Inflammatory arthritis (e.g. ankylosing spondylitis).
(vii) Metabolic or endocrine disorders (e.g. type I or type II diabetes).
(viii) Neurological disorders (e.g. Charcot-Marie-Tooth disease).
(ix) Previous breast cancer and/or use of oestrogen inhibitors.
(x) Treatment with heel lifts or calf muscle eccentric exercise within the previous three months.
(xi) Use of fluoroquinolone antibiotics within the previous two years.
(xii) Injection of local anaesthetic, corticosteroid or other pharmaceutical agent into the Achilles tendon or surrounding area within the previous three months.
(xiii) Any medical condition that, in the opinion of the investigators, makes the participant unsuitable for inclusion (e.g. clinically important pain in the musculoskeletal system other than the Achilles tendon).
(xiv) Cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire).

For the current proposed study, the key exclusion criterion is:
(a) having not participated and completed the registered RCT "The effectiveness of heel lifts versus calf muscle eccentric exercise for Achilles tendinopathy: a randomised controlled trial" (ACTRN12617001225303)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified permuted block randomisation.

Allocation will be stratified based on what treatment they received, either heel lifts or eccentric exercise, during the original RCT.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analysis will be performed within the latest version of SPSS. Due to the short time-frame and and due to the primary outcome measures being ordinal, missing data will not be imputed. Any participant who has not completed both a PGIC Likert scale and Tampa scale of kinesiophobia at all timepoints will be excluded from the study. Differences in the primary outcomes over-time and between groups will be assessed using a Generalised Estimating Equation to fit a repeated measures ordinal logistic regression, with the imaging reporting group used as the independent variable. Continuous-scaled outcome measures will be analysed using analysis of covariance (ANCOVA) with the intervention group entered as independent variables. Both 95% confidence intervals and p-values will be generated where appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/01/2018
Actual
2/02/2018
Date of last participant enrolment
Anticipated
30/04/2018
Actual
26/02/2018
Date of last data collection
Anticipated
25/06/2018
Actual
25/05/2018
Sample size
Target
70
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 18411 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 298467 0
University
Name [1] 298467 0
La Trobe University
Country [1] 298467 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Melbourne, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 297393 0
Individual
Name [1] 297393 0
Dr Sean Docking
Address [1] 297393 0
La Trobe University, Melbourne, Victoria, 3086
Country [1] 297393 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299277 0
La Trobe Human Ethics Committee
Ethics committee address [1] 299277 0
Ethics committee country [1] 299277 0
Australia
Date submitted for ethics approval [1] 299277 0
22/01/2018
Approval date [1] 299277 0
29/01/2018
Ethics approval number [1] 299277 0
HEC17-064

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

Contacts
Principal investigator
Name 79882 0
Dr Sean Docking
Address 79882 0
La Trobe Sports and Exercise Medicine Research Centre
School of Allied Health
La Trobe University
Melbourne
VIC 3086
Country 79882 0
Australia
Phone 79882 0
+61 3 9479 3115
Fax 79882 0
Email 79882 0
[email protected]
Contact person for public queries
Name 79883 0
Sean Docking
Address 79883 0
La Trobe Sports and Exercise Medicine Research Centre
School of Allied Health
La Trobe University
Melbourne
VIC 3086
Country 79883 0
Australia
Phone 79883 0
+61 3 9479 3115
Fax 79883 0
Email 79883 0
[email protected]
Contact person for scientific queries
Name 79884 0
Sean Docking
Address 79884 0
La Trobe Sports and Exercise Medicine Research Centre
School of Allied Health
La Trobe University
Melbourne
VIC 3086
Country 79884 0
Australia
Phone 79884 0
+61 3 9479 3115
Fax 79884 0
Email 79884 0
[email protected]

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


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.