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Trial registered on ANZCTR


Registration number
ACTRN12623000721606
Ethics application status
Approved
Date submitted
20/06/2023
Date registered
5/07/2023
Date last updated
15/09/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Heel lift inserts for insertional Achilles tendinopathy
Scientific title
Efficacy of heel lifts for insertional Achilles tendinopathy: a randomised pilot and feasibility trial
Secondary ID [1] 309802 0
None
Universal Trial Number (UTN)
Trial acronym
LIFTIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insertional Achilles tendinopathy 330214 0
Condition category
Condition code
Musculoskeletal 327080 327080 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 327249 327249 0 0
Other physical medicine / rehabilitation

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 for 12 weeks.

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] 326231 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 for 12 weeks.

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] 335130 0
Demand
Demand will be determined by the rate of recruitment (the number of participants recruited per month) and the conversion rate (the proportion of participants providing consent of those who met the eligibility criteria). Eligibility and enrolment data will be determined by an audit of study-specific screening and enrolment logs. The recruitment rate will be considered acceptable if three eligible participants are recruited per month, and the conversion rate will be considered acceptable if equal to or greater than 75%.
Timepoint [1] 335130 0
After the conclusion of the enrolment period.
Primary outcome [2] 335203 0
Acceptability
Acceptability of the intervention will be determined using the Credibility/Expectancy Questionnaire. The intervention will be considered acceptable if at least 75% of the intervention group score 50% or greater overall for the credibility (questions 1 to 3) and expectancy questions (questions 4 to 6).
Timepoint [2] 335203 0
At baseline post-allocation of the intervention. Participants will rate their expectations and beliefs regarding the intervention they are allocated.
Primary outcome [3] 335204 0
Adherence
Adherence will be measured at 4, 8 and 12 weeks via a REDCap survey™. Participants will be asked to provide information regarding the average number of hours per day and number of days they have worn the heel lifts during the preceding four weeks. Adherence will be considered acceptable if at least 75% of participants wear their allocated intervention (i.e., heel lift or sham heel lifts) for an average of at least 5 hours per day over the 12-week follow-up period.
Timepoint [3] 335204 0
Every 4 weeks up to 12 weeks post-commencement of the intervention.
Secondary outcome [1] 423179 0
Limited efficacy testing: The key outcome measure is 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] 423179 0
Baseline and 12 weeks post-commencement of the intervention.
Secondary outcome [2] 423180 0
Pain, disability and participation assessed using the Victorian Institute of Sport Assessment - Achilles (VISA-A).
Timepoint [2] 423180 0
Baseline and 12 weeks post-commencement of the intervention.
Secondary outcome [3] 423181 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 [3] 423181 0
12 weeks post-commencement of the intervention
Secondary outcome [4] 423182 0
Function (measured using the Lower Extremity Functional Scale)
Timepoint [4] 423182 0
Baseline and 12 weeks post-commencement of the intervention.
Secondary outcome [5] 423183 0
Health-related quality of life (measured using the VAS component of the EuroQol 5 Dimension 5 Level questionnaire)
Timepoint [5] 423183 0
Baseline and 12 weeks post-commencement of the intervention.
Secondary outcome [6] 423184 0
Level of physical activity (measured using the International Physical Activity Questionnaire - short form)
Timepoint [6] 423184 0
Baseline and 12 weeks post-commencement of the intervention.
Secondary outcome [7] 423185 0
Use of paracetamol rescue medication to relieve pain at the Achilles tendon(s) will be assessed via REDCap surveys™.
Timepoint [7] 423185 0
Weeks 4, 8 and 12 post-commencement of intervention.
Secondary outcome [8] 423438 0
Primary outcome: Adverse events
Adverse events from the interventions (such as skin blistering or the occurrence of new pain or injuries in other areas of the foot and body) will be assessed at 4, 8 and 12 weeks via a REDCap survey™. Participants will be asked to document the type of adverse event, the body location, the duration, and severity of the event (i.e., mild, moderate, or severe). An independent assessor will assess all adverse events as unrelated, probably related or definitely related, and only those considered to be probably or definitely related will be considered an adverse event. Serious adverse events will be defined as events that are life-threatening, require hospitilisation, or result in persistent or significant difficulty or incapacity. An open-response type format will also be available for participant responses. The rate of adverse events will be considered acceptable if less than 15% and none are considered serious.
Timepoint [8] 423438 0
Every 4 weeks up to 12 weeks post-commencement of the intervention.
Secondary outcome [9] 423439 0
Primary outcome: Retention
Retention rate is the proportion of recruited participants who complete the 12-week outcome assessment. Retention will be determined by an audit of study-specific adherence data. A retention rate of at least 80% in each group will be considered acceptable.
Timepoint [9] 423439 0
After the conclusion of the intervention period (12 weeks)

Eligibility
Key inclusion criteria
i) Aged 18 to 65 years
ii) Symptoms of insertional 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 at least 10 mm 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 insertional 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 distal 2 cm Achilles tendon 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 insertion 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) Achilles tendon disorders that are not insertional (e.g., mid-portion Achilles tendinopathy)
iii) Previous Achilles tendon rupture or surgery in the symptomatic lower limb
iv) 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)
v) Concurrent conditions (ankle or other region) that are more severe (pain numerical rating scale) than their worst insertional Achilles tendinopathy pain
vi) Treatment with foot orthoses or heel lifts within the previous three months
vii) Previous breast cancer/and or use of oestrogen inhibitors
viii) Inflammatory arthritis (e.g., psoriatic arthritis)
ix) Neurological disorders (e.g., Charcot-Marie-Tooth disease)
x) Taken fluoroquinolones within the previous two years
xi) Any injection (e.g., corticosteroid) into the Achilles tendon or surrounding area in the previous three months
xii) 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
Safety/efficacy
Statistical methods / analysis
This is a pilot and feasibility trial, so it is not fully powered to detect statistically significant differences between the groups. The recommended sample size for feasibility and pilot studies is 12 people per group, however, to allow for a 10% drop-out rate, we will recruit 26 participants.

As this is a feasibility study, it is not powered to detect changes in outcome measures, so the focus will not be on inferential testing. Descriptive statistics will be used to report feasibility outcomes. Mean (SD) scores and mean differences (95% CI), with Cohen’s d, will be used to explore differences in continuous variables between the groups. For dichotomous-scaled outcome measures, risk difference and relative risk (95%) will be used for between group differences. The difference in the pain intensity (at its worst) outcome measure between groups at 12 weeks (analysis of covariance, adjusted for baseline differences) will be used to inform the sample size calculation for the main randomised trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/08/2023
Actual
20/08/2023
Date of last participant enrolment
Anticipated
20/08/2025
Actual
Date of last data collection
Anticipated
20/12/2025
Actual
Sample size
Target
26
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 40599 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 313985 0
Self funded/Unfunded
Name [1] 313985 0
Professor Shannon Munteanu
Country [1] 313985 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Wellington road, Clayton, VIC-3800
Country
Australia
Secondary sponsor category [1] 315867 0
Individual
Name [1] 315867 0
Professor Peter Malliaras
Address [1] 315867 0
Monash University
Wellington road, Clayton, VIC-3800
Country [1] 315867 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313122 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 313122 0
Monash University
Wellington road, Clayton, VIC-3800
Ethics committee country [1] 313122 0
Australia
Date submitted for ethics approval [1] 313122 0
18/06/2023
Approval date [1] 313122 0
18/07/2023
Ethics approval number [1] 313122 0
39058

Summary
Brief summary
Primary aim is to evaluate the feasibility of conducting a randomised trial comparing heel lifts to a sham heel lift for reducing pain associated with insertional Achilles tendinopathy.

Secondary aim is to obtain statistical parameters to inform the main trial sample size calculation and provide a signal of efficacy to justify the future main trial.

Hypothesis: Heel lifts will lead to superior outcomes to a sham innersoles for insertional Achilles tendinopathy and a full-powered trial will be feasible.
Trial website
https://www.monashachillesstudy.com/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127074 0
Mr Jaryd Bourke
Address 127074 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 127074 0
Australia
Phone 127074 0
+613 9904 4502
Fax 127074 0
Email 127074 0
jaryd.bourke@monash.edu
Contact person for public queries
Name 127075 0
Mr Jaryd Bourke
Address 127075 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 127075 0
Australia
Phone 127075 0
+613 9904 4502
Fax 127075 0
Email 127075 0
jaryd.bourke@monash.edu
Contact person for scientific queries
Name 127076 0
Mr Jaryd Bourke
Address 127076 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 127076 0
Australia
Phone 127076 0
+613 9904 4502
Fax 127076 0
Email 127076 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.