Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000627651
Ethics application status
Approved
Date submitted
30/05/2023
Date registered
7/06/2023
Date last updated
15/09/2023
Date data sharing statement initially provided
7/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Heel lift inserts for pain of the Achilles tendon
Scientific title
Efficacy of heel lifts for mid-portion Achilles tendinopathy: a randomised controlled trial
Secondary ID [1] 309715 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LIFT (efficacy of heeL lIfts For mid-portion achilles Tendinopathy)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles tendinopathy 330123 0
Condition category
Condition code
Musculoskeletal 327005 327005 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Heel lifts (intervention group): Participants allocated to the intervention group will be given a pair of commercially available heel lifts (Clearly Adjustable) for bilateral use. The heel lifts are 12 mm in height and made from firm (Shore A 90) multi-layered clear vinyl. To maximise comfort, a 3.2 mm PPT Ultralux top cover will be adhered to the top surface. The heel lifts will be reduced in 1 mm increments if required (e.g., heel slippage) and the final height will be recorded at baseline. Small, medium, and large heel lifts will be available and issued according to the participant’s shoe size. Participants will be asked to wear them for at least 8 hours every day.

Education: Both groups will be asked to maintain their regular activities/occupations (rather than complete rest), provided the amount of pain they experience in the Achilles tendon pain does not exceed a score of 5 on a 0–10 pain scale, where 0 is no pain and 10 is worst pain imaginable during exercise/activity. The pain after usual physical activities can reach a 5 on the pain scale but should subside by the following morning. During activity, if the pain in the Achilles tendon exceeds 5 on the pain scale participants will need to reduce their activity/exercise (if possible).

There will be a 20-minute session at baseline where a trial investigator (JB) will demonstrate how to use the heel lifts, provide participants with their education, and answer any questions they possess. In addition, the participants will receive a handout containing instructions about the shoe inserts and education, which has been designed specifically for the study.

Adherence to the intervention (heel lifts) in both groups will be assessed at monthly intervals up to 12 weeks via REDCap surveys. Participants will provide information regarding the average number of hours per day and number of days they have worn their intervention during the previous 4 weeks.
Intervention code [1] 326172 0
Treatment: Devices
Comparator / control treatment
Sham heel lifts (control group): Participants allocated to the control group will receive a pair of the sham heel lifts. The intended design of the sham intervention is to not plantarflex the ankle joint but appear as identical to the heel lifts as possible. To achieve this, the sham heel lift will extend the entire length of the shoe and will be made of the same materials as the heel lift (i.e., 1 mm of clear vinyl with a 3.2 mm PPT Ultralux top cover). The sham intervention will be sized according to shoe size and trimmed (if needed) to fit into the participant’s footwear. Participants will be asked to wear them for at least 8 hours every day.

Education: Both groups will be asked to maintain their regular activities/occupations (rather than complete rest), provided the amount of pain they experience in the Achilles tendon pain does not exceed a score of 5 on a 0–10 pain scale, where 0 is no pain and 10 is worst pain imaginable during exercise/activity. The pain after usual physical activities can reach a 5 on the pain scale but should subside by the following morning. During activity, if the pain in the Achilles tendon exceeds 5 on the pain scale participants will need to reduce their activity/exercise (if possible).

There will be a 20-minute session at baseline where a trial investigator (JB) will demonstrate how to use the sham heel lifts, provide participants with their education, and answer any questions they possess. In addition, the participants will receive a handout containing instructions about the shoe inserts and education, which has been designed specifically for the study.

Adherence to the intervention (sham heel lifts) in both groups will be assessed at monthly intervals up to 12 weeks via REDCap surveys. Participants will provide information regarding the average number of hours per day and number of days they have worn their intervention during the previous 4 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 334863 0
Pain intensity at its worst in the previous week using a 11-point numerical rating scale (NRS) with terminal descriptors of ‘no pain’ (score = 0) and ‘worst pain possible’ (score = 10).
Timepoint [1] 334863 0
Baseline and 12 weeks post-commencement of the intervention. Twelve weeks is the primary time-point.
Secondary outcome [1] 422276 0
Pain, disability and participation assessed using the Victorian Institute of Sport Assessment - Achilles (VISA-A).
Timepoint [1] 422276 0
Baseline and 12 weeks post-commencement of the intervention.
Secondary outcome [2] 422277 0
Global Rating of Change Scale (measured using a 15-point Likert scale ranging from a ‘very great deal worse’ to a ‘very great deal better'). This variable was dichotomised, with ‘effective’ defined as “somewhat better” or above.
Timepoint [2] 422277 0
12 weeks post-commencement of the intervention
Secondary outcome [3] 422278 0
Function (measured using the Lower Extremity Functional Scale)
Timepoint [3] 422278 0
Baseline and 12 weeks post-commencement of the intervention.
Secondary outcome [4] 422279 0
Health-related quality of life (measured using the VAS component of the EuroQol 5 Dimension 5 Level questionnaire)
Timepoint [4] 422279 0
Baseline and 12 weeks post-commencement of the intervention.
Secondary outcome [5] 422280 0
Level of physical activity (measured using the International Physical Activity Questionnaire - short form)
Timepoint [5] 422280 0
Baseline and 12 weeks post-commencement of the intervention.
Secondary outcome [6] 422281 0
Use of paracetamol rescue medication to relieve pain at the Achilles tendon(s) will be assessed via REDCap surveys.
Timepoint [6] 422281 0
Weeks 4, 8 and 12 post-commencement of intervention.
Secondary outcome [7] 422282 0
Adverse events (such as new pains in the body, rolled ankles, blisters, swelling) will be assessed via REDCap surveys.
Timepoint [7] 422282 0
Weeks 4, 8 and 12 post-commencement of intervention.
Secondary outcome [8] 422283 0
Adherence to the interventions (shoe inserts) via REDCap surveys. Participants will provide information regarding the average number of hours per day and number of days they have worn their inserts during the previous 4 weeks.
Timepoint [8] 422283 0
Weeks 4, 8 and 12 post-commencement of intervention.
Secondary outcome [9] 422598 0
Use of co-interventions to relieve pain at the Achilles tendon(s) will be assessed via REDCap surveys.
Timepoint [9] 422598 0
Weeks 4, 8 and 12 post-commencement of intervention.
Secondary outcome [10] 422599 0
Changes in biomechanical parameters while using the allocated intervention in a subpopulation of the participants (n = 40). This includes measures of Achilles tendon load, ankle joint moments and plantar/dorsiflexion range of motion, stance phase duration, ground reaction force, and tibial acceleration.
Timepoint [10] 422599 0
Baseline post-allocation of intervention.

Eligibility
Key inclusion criteria
i) Aged 18 to 65 years
ii) Symptoms of mid-portion Achilles tendinopathy in one or both lower limb(s) for > 6 weeks
iii) Report maximum Achilles tendon pain severity experienced over the past week that is > 3 out of 10 (using a numerical pain rating scale)
iv) Regularly use footwear that can accommodate heel lifts. This is defined as using footwear that can accommodate heel lifts for at least eight hours per day
v) Be literate in English and able to complete the questionnaires used in this trial (e.g., VISA-A questionnaire)
vi) Be willing to not receive any treatment on the involved Achilles tendon(s) (other than those allocated in the current study) during the study period
vii) Be willing and able to attend Victoria University (Melbourne, Australia) on one occasion for assessment

Clinical diagnosis of mid-portion Achilles tendinopathy based on the following criteria:

a) Report pain in the Achilles tendon during or after weight-bearing activities including walking, running or jumping/hopping
b) Pain in the Achilles tendon 2-6 cm proximal to the insertion (as described by the patient and palpated by the investigator)
c) Gray-scale musculoskeletal ultrasound of the Achilles tendon(s) showing diffuse or local thickening (anterior-posterior) and/or irregular fibre orientation and/or hypoechoic areas within the mid-portion of the Achilles tendon.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Currently pregnant
ii) Previous Achilles tendon rupture or surgery in the symptomatic lower limb
iii) Injury or pathology of the lower limb and/or back or any condition that, in the opinion of the investigators, may interfere with participation in the study (e.g., chronic ankle instability)
iv) Concurrent conditions (ankle or other region) that are more severe (pain numerical rating scale) than their worst mid-portion Achilles tendinopathy pain
v) Treatment with foot orthoses or heel lifts within the previous three months
vi) Previous breast cancer/and or use of oestrogen inhibitors
vii) Inflammatory arthritis (e.g., psoriatic arthritis)
viii) Neurological disorders (e.g., Charcot-Marie-Tooth disease)
ix) Taken fluoroquinolones within the previous two years
x) Any injection (e.g., corticosteroid) into the Achilles tendon or surrounding area in the previous three months
xi) Any medical condition that deems a participant unsuitable, based on the opinion of the investigators (e.g., type I or II diabetes)

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)
Central randomisation (website Sealed Envelope).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be provided by an external provider. Using the website Sealed Envelope, participants will be randomised on a 1:1 ratio with permuted block sizes.
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
The sample size has been determined a priori using G*Power based on pain intensity (at its worst) as the primary outcome measure. We calculated the sample size using an f-test, analysis of covariance (ANCOVA). Using an allocation ratio of 1:1, 90% power, minimal clinically important difference of 1.5 units out of 10, standard deviation of 2.3, moderate effect size (f = 0.33), and a significance level set at a < 0.05, we estimate that a total of 108 participants will be required (99 and an extra 9 for 10% drop-out).

Statistical analysis will be performed using the most recent version of SPSS (IBM Corp., Armonk, NY, USA) available at the time of analysis and data stored in Lab Archives, a secure cloud-based server. Data will be double entered to minimise errors. Demographic data and anthropometric characteristics (e.g., gender, age, foot posture using the FPI, etc.) will be reported by the treatment arm.

The intention-to-treat principle will be used for all participants. Multiple imputation will be used to replace missing data for the primary and secondary outcome measures; with the exception being ‘Global Rating of Change Scale), where no data substitution will be applied. Standard tests to assess continuous data for normal distribution will be used and transformation performed if required. The primary outcome measure assessed will be pain intensity (at its worst) at 12 weeks. Continuously scored outcome measures will be analysed using an ANCOVA with adjustment for baseline scores.

Dichotomous data (Global Rating of Change Scale, adverse events and use of co-interventions) will be compared using relative risk, absolute risk increase and number needed to treat or harm. Intervention adherence, and CEQ data will be compared between groups using independent t-tests. To complement point estimates, standard deviations, 95% confidence intervals and p-values will be calculated where appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/08/2023
Actual
20/08/2023
Date of last participant enrolment
Anticipated
20/08/2025
Actual
Date of last data collection
Anticipated
12/11/2025
Actual
Sample size
Target
108
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 40463 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 313909 0
Charities/Societies/Foundations
Name [1] 313909 0
Australian Podiatry Education and Research Foundation
Country [1] 313909 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Wellington road, Clayton, VIC-3800
Country
Australia
Secondary sponsor category [1] 315763 0
Individual
Name [1] 315763 0
Professor Peter Malliaras
Address [1] 315763 0
Monash University
Wellington road, Clayton, VIC-3800
Country [1] 315763 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313055 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 313055 0
Monash University
Wellington road, Clayton, VIC-3800
Ethics committee country [1] 313055 0
Australia
Date submitted for ethics approval [1] 313055 0
17/04/2023
Approval date [1] 313055 0
23/05/2023
Ethics approval number [1] 313055 0
36420

Summary
Brief summary
Primary aim: To examine the efficacy of heel lifts versus sham on pain intensity among individuals with mid-portion Achilles tendinopathy at 3 months.

Secondary aim: to investigate the acute biomechanical effects of heel lifts among individuals with mid-portion Achilles tendinopathy.

The primary outcome measure will be pain intensity (at its worst) at 12 weeks.

Study hypothesis: Heel lifts will lead to a superior outcome in the pain intensity measure compared to sham at 12 weeks.
Trial website
https://www.monashachillesstudy.com/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126834 0
Mr Jaryd Bourke
Address 126834 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 126834 0
Australia
Phone 126834 0
+613 9904 4502
Fax 126834 0
Email 126834 0
jaryd.bourke@monash.edu
Contact person for public queries
Name 126835 0
Mr Jaryd Bourke
Address 126835 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 126835 0
Australia
Phone 126835 0
+613 9904 4502
Fax 126835 0
Email 126835 0
jaryd.bourke@monash.edu
Contact person for scientific queries
Name 126836 0
Mr Jaryd Bourke
Address 126836 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 126836 0
Australia
Phone 126836 0
+613 9904 4502
Fax 126836 0
Email 126836 0
jaryd.bourke@monash.edu

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.