Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000462482p
Ethics application status
Submitted, not yet approved
Date submitted
22/04/2025
Date registered
15/05/2025
Date last updated
15/05/2025
Date data sharing statement initially provided
15/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Is Achilles tendinopathy pain education with or without exercise, more effective than usual care, in improving pain cognitions in those with midportion Achilles tendinopathy? A pilot and feasibility study
Scientific title
Is Achilles tendinopathy pain education with or without exercise, more effective than usual care, in improving pain cognitions in those with midportion Achilles tendinopathy? A pilot and feasibility study
Secondary ID [1] 313515 0
None
Universal Trial Number (UTN)
Trial acronym
EDUCATE (EDUCation in Achilles TEndinopathy)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Midportion Achilles Tendinopathy 335948 0
Condition category
Condition code
Musculoskeletal 332538 332538 0 0
Other muscular and skeletal disorders
Injuries and Accidents 333687 333687 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This three-arm parallel group feasibility trial will compare three interventions: Arm 1: Achilles Tendinopathy Pain Education (ATPE) Arm 2: Achilles Tendinopathy Pain Education plus Exercise (ATPE+Ex). Arm 3. Usual Care (Exercise + Advice). Each of these three groups will receive one-on-one treatment from a qualified physiotherapist.

The ATPE will be based on a previously published protocol.(1) A flexible clinical reasoning approach adopted from cognitive functional therapy has been described in the literature and will be applied to augment this previously published education intervention protocol.(2) This will include: giving space for the participant to provide their story, flexible communication and asking the patient to identify key concerns/priorities and goals.(1)

Education will be standardized via pre-recorded modules presented through Microsoft PowerPoint and, also available as a printable pdf document.

Whilst education content will be standardized, there will be opportunity for individualized clarification throughout the presentation, as these will be watched in session, alongside the interventionist physiotherapist. Following the slide presentation, the physiotherapist will encourage the patient participant to reflect on the educational content and how it can be applied to their own situation and goals, aligning with the cognitive functional therapy approach.(2) Both the enactment of this self-reflection and the quality of the participants engagement will be assessed as part of the intervention's delivery and receipt fidelity assessment.

Interventions:
Participants will be randomly allocated to one of the 3 intervention arms (Arm 1 - ATPE, Arm 2 - ATPE+Ex or Arm 3 - usual care) by random number generation.

All intervention groups:
All interventions will be delivered by AHPRA registered physiotherapists with greater than 5 years' experience. Participants will attend their designated physiotherapist for one session per week for 6 weeks. Interventionist physiotherapists (and their affiliated private practice) will be designated only one treatment arm to prevent between-group contamination. The initial treatment visit will be 30 minutes (ATPE; Usual Care) and 45 minutes (ATPE+Ex) with follow up appointments 20 and 30 minutes respectively.

ATPE arm
The education intervention will combine elements from pain neuroscience education and cognitive functional therapy and will cover 6 key pain neuroscience elements and 3 cognitive functional therapy elements:

The 6 key pain neuroscience elements from Post et al (1) will include:
1. The concept of load and load intolerance in Achilles tendinopathy
2. How to improve Achilles load capacity by progressive exercise & the difference between Achilles tendinopathy & rupture
3. Understanding common Achilles imaging findings
4. Neurobiological pain mechanisms and psychological factors
5. Nervous system sensitivity in persistent pain
6. Benefits of exercise for chronic musculoskeletal pain and Australian Government Physical Activity guidelines

Cognitive Functional therapy elements from Kent et al (2):
1. Making sense of pain
2. Exposure with control/graded exposure
3. Lifestyle modifications

Achilles Tendinopathy Pain Education (ATPE) as a stand-alone intervention will be a comparator to determine whether any benefits of the combined intervention group are due to the education component or the exercise component. We also wish to determine how well ATPE performs on its own.

Session attendance and patient completion of reflective questions will be recorded.

ATPE+Ex group
All participants assigned to the ATPE+Ex group will receive the same education component delivered to the ATPE group, described above. ATPE+Ex participants will receive an additional 15 minutes of clinical intervention to accommodate the exercise component.

Session attendance and patient adherence to their home exercise program will be recorded via the Physitrack App.

ATPE+Ex participants will be prescribed an exercise program in accordance with the TEAch protocol. (1) These will be instructed by the same physiotherapist for each session. Exercises will be reinforced by video demonstrations using the Physitrack App (Physitrack PLC, United Kingdom). The exercise intervention will be delivered through three phases: Isometric (for example isometric single leg standing heel raises), isotonic (for example standing or seated heel raises) and plyometric (for example alternating leg hops).(1) Criteria-based progression will occur based on the TEAch protocol (1) Participants will be prescribed there exercise program within this session based on the TEAch protocol. Prescribed isometric exercises will be prescribed 1/day 7/week. Prescribed isotonic exercises will be prescribed 1/day 3/week and plyometric exercises 1/day 2/week. Each home-based exercise session will take approximately 10 minutes.

Achilles Tendinopathy Pain Education (ATPE) as a stand-alone intervention will be a comparator to determine whether any benefits of the combined intervention group are due to the education component or the exercise component. We also wish to determine how well ATPE performs on its own.

References:
1. Post AA, Rio EK, Sluka KA, Lorimer Moseley G, Bayman EO, Hall MM, et al. Effect of pain education and exercise on pain and function in chronic achilles tendinopathy: Protocol for a double-blind, placebo-controlled randomized trial. JMIR Research Protocols. [Article]. 2020;9(11).
2. Kent P, Haines T, O'Sullivan P, Smith A, Campbell A, Schutze R, et al. Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial. Lancet. [Article]. 2023;401(10391):1866-77.
Intervention code [1] 330088 0
Rehabilitation
Comparator / control treatment
The Usual Care arm will serve as a control group in this pilot and feasibility trial. Usual care will be based on clinical practice guidelines for management of midportion Achilles tendinopathy (1). These guidelines recommend the following treatments SHOULD be used in the management of midportion Achilles tendinopathy: Tendon loading exercises, education & counselling and/or multimodal interventions.(1) The guidelines recommend that the following treatments MAY be used: Neuromuscular exercises targeting lower extremity impairments, manual therapy, dry needling, heel lifts, taping. (1) The usual care group interventions will include those listed as either 'should be used' or 'may be used' by the clinical practice guidelines.

Usual care sessions will also be one-on-one and conducted 1/week for 6 weeks. Initial session will run for 30 minutes and each subsequent session for 20 minutes. Attendence to these sessions will be recorded and exercises will be prescribed via the Physitrack App so that adherence can be recorded.

We will engage our usual care delivering physiotherapists in a focus group/co-design process and present the clinical practice guidelines for discussion. The aim of the focus group group will be to discuss how to best implement these guidelines in a clinical setting. The focus group will be completed prior to the beginning of the trial. It will involve 1 x 2 hour session 2 weeks before the anticipated first randomisation.

Reference:
1. Chimenti RL, Neville C, Houck J, Cuddeford T, Carreira D, Martin RL. Achilles Pain, Stiffness, and Muscle Power Deficits: Midportion Achilles Tendinopathy Revision - 2024. J Orthop Sports Phys Ther. 2024 Dec;54(12):1-32.
Control group
Active

Outcomes
Primary outcome [1] 340109 0
Recruitment rate
Timepoint [1] 340109 0
6 weeks post completion of week 6 of intervention 46 weeks post completion of week 6 of intervention
Primary outcome [2] 340110 0
Fidelity of delivery
Timepoint [2] 340110 0
Assessment of completed checklists by interventionist physiotherapists following intervention sessions of Week 1, 3 and 6.
Primary outcome [3] 340111 0
Intervention acceptability
Timepoint [3] 340111 0
Following completion of intervention session of week 6.
Secondary outcome [1] 442757 0
Adherence to exercise program (ATPE+Ex and Usual Care groups)
Timepoint [1] 442757 0
Following completion of intervention session of week 6.
Secondary outcome [2] 442758 0
Adverse Events (symptom flare)
Timepoint [2] 442758 0
From study commencement through to 52 weeks post intervention commencement.
Secondary outcome [3] 442759 0
Kinesiophobia
Timepoint [3] 442759 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [4] 442760 0
Pain Catastrophizing
Timepoint [4] 442760 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [5] 442761 0
Distress
Timepoint [5] 442761 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [6] 442762 0
Fear of Pain
Timepoint [6] 442762 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [7] 442763 0
Pain Interference
Timepoint [7] 442763 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [8] 442764 0
Achilles pain severity over last 7 days (worst during activity)
Timepoint [8] 442764 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [9] 442765 0
Disability
Timepoint [9] 442765 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [10] 442767 0
Function
Timepoint [10] 442767 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [11] 442768 0
Health related quality of life
Timepoint [11] 442768 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of session intervention 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [12] 442769 0
Symptom acceptability
Timepoint [12] 442769 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [13] 442770 0
Overall symptom evaluation
Timepoint [13] 442770 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [14] 444608 0
Physical Activity
Timepoint [14] 444608 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [15] 444759 0
Depression, Anxiety and Stress (composite outcome measure with separate scoring for each of the three subdomains)
Timepoint [15] 444759 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [16] 445300 0
Pain Self Efficacy
Timepoint [16] 445300 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [17] 445513 0
Success of blinding and expectation bias (assessed as a composite outcome)
Timepoint [17] 445513 0
Immediately following completion of intervention session 6
Secondary outcome [18] 447175 0
Recruitment cost (primary outcome)
Timepoint [18] 447175 0
6 weeks post completion of week 6 of intervention 46 weeks post completion of week 6 of intervention
Secondary outcome [19] 447176 0
Retention rate (primary outcome)
Timepoint [19] 447176 0
6 weeks post completion of week 6 of intervention 46 weeks post completion of week 6 of intervention
Secondary outcome [20] 447177 0
Completion rate (primary outcome)
Timepoint [20] 447177 0
6 weeks post completion of week 6 of intervention 46 weeks post completion of week 6 of intervention
Secondary outcome [21] 447178 0
ATPE and ATPE+Ex groups Percentage completion of home tasks
Timepoint [21] 447178 0
At week 2, week 3, week 4, week 5 and week 6 physiotherapy sessions of intervention program.
Secondary outcome [22] 447179 0
Adherence to session attendance
Timepoint [22] 447179 0
Following completion of session number 6 of intervention program.
Secondary outcome [23] 447183 0
Fidelity of receipt
Timepoint [23] 447183 0
-COPI-Adult: Baseline (post randomization and within 48 hours of attendance at intervention session 1) and following completion of session 6 -Quality of engagement in education content: Assessment of webcam footage of intervention sessions of Week 1, 3 and 6. -Quality in engagement of session: Assessment of webcam footage of intervention sessions of Week 1, 3 and 6. -Access of program link: Interventionist physiotherpay checklist completion following Weeks 1, 3 and 6.
Secondary outcome [24] 447192 0
Adverse event (distress)
Timepoint [24] 447192 0
From study commencement through to 52 weeks post intervention commencement.
Secondary outcome [25] 447193 0
Adverse event (other)
Timepoint [25] 447193 0
From study commencement through to 52 weeks post intervention commencement.
Secondary outcome [26] 447195 0
Achilles pain severity over last 7 days (worst following activity)
Timepoint [26] 447195 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention
Secondary outcome [27] 447196 0
Achilles pain severity over last 7 days (average level of pain)
Timepoint [27] 447196 0
-Baseline (post randomization and within 48 hours of attendance at intervention session 1) -Immediately following completion of intervention session 6 -6 weeks post completion of week 6 of intervention -46 weeks post completion of week 6 of intervention

Eligibility
Key inclusion criteria
1. Adults over 18 years
2. Clinical diagnosis of mid-portion Achilles tendinopathy based on the following criteria:
-A gradual onset of well localized pain to the Achilles tendon mid-portion that coincides with a change in loading activity and is provoked by stretch-shorten cycle loads on the Achilles such as walking, running, jumping or hopping (1)
-Reproduction of well localized pain to the Achilles tendon midportion with walking, running, calf raise or hop tasks at clinical evaluation (1, 2)
-Localized tendon pain on palpation that corresponds to region of symptoms (2)
3. Evidence of Achilles tendon pathology on real-time ultrasound examination.
4. Other secondary musculoskeletal injuries will be accepted provided that the Achillies tendinopathy is designated as the primary complaint by the participant.

References:
1. Malliaras P. Physiotherapy management of Achilles tendinopathy. Journal of Physiotherapy 2022;68:17.
2. Chimenti RL, Post AA, Rio EK, Moseley GL, Dao M, Mosby H, et al. The effects of pain science education plus exercise on pain and function in chronic Achilles tendinopathy: A blinded, placebo-controlled, explanatory, randomized trial. Pain. 2023;164(1):E47-E65.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-Achilles tendinopathy presentation or coexisting musculoskeletal injury in which the Achilles tendinopathy is not the primary complaint
2. Insertional Achilles tendinopathy
3. Achilles tendon pain for less than 3 months
4. History of Achilles tendon rupture on either side
5. History of invasive procedures to the affected Achilles tendon (such as ultrasound guided procedure or any surgical intervention)
6. Physiotherapy treatment for the Achilles tendinopathy within the last 12 weeks
7. Pregnancy
8. Below 18 years of age
9. Unable to read and/or write in English
10. Has coexisting systemic conditions that may contribute to the pain presentation such as: rheumatic conditions, spondyloarthropathies, cancer, neurological conditions, endocrinological conditions, uncontrolled diabetes or connective tissue disorders
11. Has a cardiovascular condition that limits or prevents participation in an exercise program
12. Has been diagnosed with a current psychiatric or mood DSM-listed disorder by a psychologist or psychiatrist
13. History of taking fluroquinolones in the last 3 months
14. Participant unable to commit to a 6-week intervention period

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)
Allocation will be concealled using computer generated allocation by a member of the research team not involved in eligibility assessment (supervisors Angie Fearon or Andrew Flood). This independent research team member will send an email directly to the participant informing them of allocation to off-site interventionist physiotherapy clinic.

Whilst participants will be informed of which physiotherapy clinic to attend, they will not be informed of which group they were assigned to (ATPE, ATPE + Ex or Usual Care), or which intervention is expected to deliver the best outcomes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be facilitated by computer generated/computer sequenced generation and will be stratified by geographic location (North or South Canberra) and trial site. Participants will be assigned to either region based on their location of residence to minimize inconvenience and will be randomized to either of the intervention groups or wait-and-see group. This process will continue until we have reached our required sample size of 45 participants. Six independent physiotherapists will each deliver only one intervention (ATPE OR ATPE+Ex OR Usual Care). Three will be located in the North Canberra region: one delivering ATPE, one delivering ATPE+Ex and one delivering usual care. The other three physiotherapists will be located in the South Canberra region: one delivering ATPE, one delivering ATPE+Ex and one delivering usual care.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics (mean, SD, median and range) will be used to compare groups at baseline assessment. Group differences will be assessed via generalized mixed modelling for continuous data accounting for potentially influential factors including age, sex, BMI and physiotherapist. Mann-Whitney U test will be used for categorical data. All comparative data will be from patient reported outcome measures and will be treated as continuous. Generalized linear models will also be used for repeat measures to assess the effect sizes of follow-up clinical measures.

A range of demographic information will be collected through the baseline survey to align with consensus for recommended standards for reporting participant characteristics in tendinopathy research. (1) This will include: biological sex, gender, limb dominance, Aboriginal/Torres Strait Islander descent, sport/athletic background, highest level of education completed, non English speaking background, gross income, general health, mental health, regular and pain medication use, smoking history, hours of sleep per night, falls history, physical activity (using the Active Australia Survey), physical activity literacy (PLAS) (2), duration of current episode Achilles tendinopathy symptoms, number of previous episodes of Achilles tendinopathy, previous treatment for Achilles tendinopathy

Reference:
1. Rio EK, Mc Auliffe S, Kuipers I, Girdwood M, Alfredson H, Bahr R, et al. ICON PART-T 2019-International Scientific Tendinopathy Symposium Consensus: recommended standards for reporting participant characteristics in tendinopathy research (PART-T). Br J Sports Med. 2020;54(11):627-30.
2. Naylor A, Flood A, Barnett LM, Keegan R. Development of the Physical Literacy in Adults Scale (PLAS). J Sports Sci. 2024 Jun;42(12):1099-111.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2025
Actual
Date of last participant enrolment
Anticipated
15/12/2025
Actual
Date of last data collection
Anticipated
15/12/2026
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 317964 0
University
Name [1] 317964 0
University of Canberra
Country [1] 317964 0
Australia
Primary sponsor type
University
Name
University of Canberra Research Institute for Sports and Exercise
Address
Country
Australia
Secondary sponsor category [1] 320301 0
None
Name [1] 320301 0
Address [1] 320301 0
Country [1] 320301 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316636 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 316636 0
Ethics committee country [1] 316636 0
Australia
Date submitted for ethics approval [1] 316636 0
01/04/2025
Approval date [1] 316636 0
Ethics approval number [1] 316636 0
13877

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

Contacts
Principal investigator
Name 138490 0
Mr Jack Mest
Address 138490 0
UC Research Institute for Sport and Exercise Building 29 11 Kirinari Street Bruce, ACT, 2617
Country 138490 0
Australia
Phone 138490 0
+610262068717
Fax 138490 0
Email 138490 0
[email protected]
Contact person for public queries
Name 138491 0
Jack Mest
Address 138491 0
UC Research Institute for Sport and Exercise Building 29 11 Kirinari Street Bruce, ACT, 2617
Country 138491 0
Australia
Phone 138491 0
+610262068717
Fax 138491 0
Email 138491 0
[email protected]
Contact person for scientific queries
Name 138492 0
Jack Mest
Address 138492 0
UC Research Institute for Sport and Exercise Building 29 11 Kirinari Street Bruce, ACT, 2617
Country 138492 0
Australia
Phone 138492 0
+610262068717
Fax 138492 0
Email 138492 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.