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Trial registered on ANZCTR


Registration number
ACTRN12617001225303
Ethics application status
Approved
Date submitted
18/08/2017
Date registered
22/08/2017
Date last updated
2/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Heel lift shoe inserts versus calf muscle eccentric exercise for Achilles tendinopathy
Scientific title
The effectiveness of heel lifts versus calf muscle eccentric exercise for Achilles tendinopathy: a randomised controlled trial
Secondary ID [1] 292670 0
Nil
Universal Trial Number (UTN)
U1111-1200-7957
Trial acronym
HEALTHY
Linked study record
-

Health condition
Health condition(s) or problem(s) studied:
Achilles tendinopathy 304413 0
Condition category
Condition code
Musculoskeletal 303743 303743 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 303744 303744 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Heel lifts (experimental group): participants randomised to the heel lift group will be provided with three pairs of Clearly adjustable [Registered Trademark] heel lift shoe inserts at the baseline assessment. The heel lifts are 12 mm in height and made from a firm multi-layered vinyl that conforms to the shape of the foot. Three sizes are available (small, medium or large) and will be issued according to the participants' shoe size. The heel lifts are commercially available and will be covered with an 3.2 mm PPT [Registered Trademark] with an Ultralux top cover to maximise comfort and adherence. Participants will be advised to wear the heel lifts as much as possible during the study (12 weeks). A handout containing instructions about the heel lifts will also be provided to participants.

Both groups will receive a modified activity program where participants will be allowed to continue with the activities that they normally have been doing provided that the amount of pain they experience in the Achilles tendon(s) does not exceed level 5 on a pain scale, where 0 is ‘no pain’ and 10 is ‘worst pain imaginable’ - during the exercise/activity. The pain after activity is allowed to reach 5 on the pain scale but should have subsided by the following morning. During activity, if the pain in the Achilles tendon increases to 6 or more on a pain scale, the participant will need to reduce their activity (if possible) so that it is less then level 6 on a pain scale.

Adherence to the intervention will be measured at 2, 6 and 12 weeks, where participants will provide information regarding the average number of hours per day and number of days they have worn the heel lifts in the last 2, 4 and 6 weeks respectively.
Intervention code [1] 298906 0
Treatment: Devices
Intervention code [2] 298929 0
Treatment: Other
Comparator / control treatment
Exercise program: participants randomised to the calf muscle eccentric exercise group will perform a rehabilitation therapy program for the duration of the study (12 weeks).

Participants will be instructed to do calf muscle eccentric exercise 2 times daily, 7 days/week, for 12 weeks. Two types of calf muscle eccentric exercise will be used. The calf muscle will be eccentrically loaded both with the knee straight and, to maximise the activation of the soleus muscle, also with the knee bent. Each of the two exercises will include 15 repetitions performed in 3 sets (3 sets of 15 repetitions). Participants with bilateral Achilles tendinopathy will be instructed to perform the eccentric exercise on both lower limbs. The participants will be told to go ahead with the exercise even if they experience pain. However, they will be advised to stop the exercise if the pain becomes disabling. When the exercise can be completed with no pain or discomfort, participants will progress to use of a back-pack with 5 kg of weight.

Both groups will receive a modified activity program where participants will be allowed to continue with the activities that they normally have been doing provided that the amount of pain they experience in the Achilles tendon(s) does not exceed level 5 on a pain scale, where 0 is ‘no pain’ and 10 is ‘worst pain imaginable’ - during the exercise/activity. The pain after activity is allowed to reach 5 on the pain scale but should have subsided by the following morning. During activity, if the pain in the Achilles tendon increases to 6 or more on a pain scale, the participant will need to reduce their activity (if possible) so that it is less then level 6 on a pain scale.

During the baseline assessment, participants will be instructed to perform the exercises correctly and this will be reviewed at 2 weeks. A handout containing instructions about the exercises will also be provided to participants in addition to a link to a video demonstrating the correct procedure. Adherence to the intervention will be measured at 2, 6 and 12 weeks, where participants will provide information regarding the average number of days per week they have performed their exercises during the past 2, 4 and 6 weeks respectively.
Control group
Active

Outcomes
Primary outcome [1] 303118 0
Total score of the Victorian Institute of Sport Assessment- Achilles (VISA-A) questionnaire. This questionnaire contains 8 questions that assesses pain, function and activity.
Timepoint [1] 303118 0
Baseline, 2, 6 and 12 weeks.
Secondary outcome [1] 337916 0
Ultrasound tissue characterization (UTC) will be used to provide quantification of the Achilles tendon structure. Structure will be determined through relative percentage of tendon echo-types (I-IV).
Timepoint [1] 337916 0
Baseline and 12 weeks.
Secondary outcome [2] 337917 0
Calf muscle function using the standing heel rise test.
Timepoint [2] 337917 0
Baseline, and 12 weeks.
Secondary outcome [3] 337918 0
Self-reported magnitude of symptom (pain) change using Patient Global Impression of Change (PGIC) 7-point Likert scale. The scale will ask participants 'compared to how you were before starting this study, 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'. Responses will then be dichotomised according to 'treatment effectiveness', where 'treatment effectiveness' is defined as responses of 'very much improved' and 'much improved'.
Timepoint [3] 337918 0
2, 6, and 12 weeks.
Secondary outcome [4] 337919 0
Self-reported magnitude of symptom (function) change using Patient Global Impression of Change (PGIC) 7-point Likert scale. The scale will ask participants 'compared to how you were before starting this study, how would you rate your ability to perform physical activities (such as walking, dancing, running, gardening, housework)?' and include the following responses 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', or 'very much worse'. Responses will then be dichotomised according to 'treatment effectiveness', where 'treatment effectiveness' is defined as responses of 'very much improved' and 'much improved'.
Timepoint [4] 337919 0
2, 6, and 12 weeks.
Secondary outcome [5] 337920 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 [5] 337920 0
Baseline, 2, 6, and 12 weeks.
Secondary outcome [6] 337921 0
General health-related quality of life will be measured using the EuroQol questionnaire (EuroQol 5D-5L).
Timepoint [6] 337921 0
Baseline, 2, 6, and 12 weeks.
Secondary outcome [7] 337922 0
Use of paracetamol rescue medication to relieve pain at the Achilles tendon will be assessed via a medications consumption diary, which has been specifically designed for this study.
Timepoint [7] 337922 0
2, 6, and 12 weeks.
Secondary outcome [8] 337923 0
Adverse events (such as new pains in the body, rolled ankle, blisters, swelling) will be assessed using a questionnaire, which has been specifically designed for this study.
Timepoint [8] 337923 0
2, 6, and 12 weeks.
Secondary outcome [9] 337924 0
The level of physical activity in the previous week will be evaluated using the 7-day Recall Physical Activity Questionnaire.
Timepoint [9] 337924 0
Baseline, 2, 6, and 12 weeks.
Secondary outcome [10] 338013 0
Adherence to interventions (heel lifts and calf muscle eccentric exercise) will be assessed using questionnaires, that have been specifically designed for this study.

For the heel lift intervention, participants will provide information regarding the average number of hours per day per week they have used the intervention over the previous 2, 4 and 6 weeks respectively (at the timepoints specified below).

For the calf muscle eccentric exercise intervention, participants will provide information regarding the average number of days per week they have performed their exercises over the previous 2, 4 and 6 weeks respectively (at the timepoints specified below).
Timepoint [10] 338013 0
2, 6, and 12 weeks.
Secondary outcome [11] 338035 0
Ultrasound tissue characterization (UTC) will be used to measure maximum Achilles tendon thickness.
Timepoint [11] 338035 0
Baseline and 12 weeks.
Secondary outcome [12] 338036 0
Use of co-interventions to relieve pain at the Achilles tendon will be assessed via a questionnaire, which has been specifically designed for this study.
Timepoint [12] 338036 0
2, 6 and 12 weeks

Eligibility
Key inclusion criteria
To be included in this study, participants must meet the following inclusion criteria:
(i) Aged 18 years or greater.
(ii) Achilles tendon pain present in one or both lower limb(s) for a minimum of 2 months.
(iii) Report having average daily pain during the past week rated at least 3 out of 10 on a numerical rating scale.
(iv) 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:
(a) insidious onset of pain in the region of the Achilles tendon, aggravated by weight bearing activity;
(b) pain located 2 to 6 cm proximal to the Achilles tendon insertion upon palpation by the investigator;
(c) musculoskeletal ultrasound of the Achilles tendon showing local thickening, irregular fibre orientation or hypoechoic areas;
(v) 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).
(vi) Regularly use footwear that can accommodate a heel lift of 12 mm height.
(vii) Able to walk household distances (more than 50 m) without the aid of a walker, crutches or cane.
(viii) 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).
(ix) 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participants in this study will be:
(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).

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 (interactive voice response telephone service).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be provided by an external provider. Participants will be allocated to the intervention groups using random permuted blocks. This change was implemented before recruitment of participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using the most recent version of SPSS version using the intention-to-treat principle for all randomised participants. In participants with bilateral symptoms, the more painful side will be analysed (or the right lower limb if they cannot define the more painful side) to maintain independence of data. Multiple imputation will be used to replace any missing data using five iterations, with sex, age, baseline scores, and group allocation as predictors. The exception will be for the variables use of rescue medication, adherence, adverse events, co-interventions, Achilles tendon structure and global change in symptoms where no data substitution will be applied. Standard tests to assess continuous data for normal distribution will be used and transformation carried out if required. Differences in the primary and secondary outcome measures between the two groups will be compared. Continuous-scaled outcome measures will be analysed using analysis of covariance (ANCOVA) with baseline scores, and intervention group entered as independent variables. Dichotomous-scaled outcome measures will be compared using relative risk, risk difference, and number needed to treat. Both 95% confidence intervals and p-values will be generated where appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2017
Actual
4/09/2017
Date of last participant enrolment
Anticipated
1/05/2018
Actual
13/12/2017
Date of last data collection
Anticipated
31/07/2018
Actual
2/03/2018
Sample size
Target
92
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 16937 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 297310 0
University
Name [1] 297310 0
La Trobe University Postgraduate Research Scholarship
Country [1] 297310 0
Australia
Funding source category [2] 297314 0
University
Name [2] 297314 0
Grant from the La Trobe University Sport Exercise and Rehabilitation Research Focus Area (SER RFA Grant Scheme)
Country [2] 297314 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Melbourne, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 296278 0
Individual
Name [1] 296278 0
Dr Shannon Munteanu
Address [1] 296278 0
La Trobe University, Melbourne, Victoria, 3086
Country [1] 296278 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298415 0
La Trobe Universtiy Human Ethics Comittee
Ethics committee address [1] 298415 0
La Trobe University, Melbourne, Victoria, 3086
Ethics committee country [1] 298415 0
Australia
Date submitted for ethics approval [1] 298415 0
30/06/2017
Approval date [1] 298415 0
11/08/2017
Ethics approval number [1] 298415 0
HEC17-064

Summary
Brief summary
The primary aim of this research project is to compare the effectiveness of heel lift shoe inserts versus rehabilitation therapy (calf muscle eccentric exercise) for the treatment of Achilles tendinopathy.

This study is a parallel group, pragmatic randomised controlled trial with a 12 week follow-up. Participants will be randomised to receive treatment with heel lift shoe inserts (Clearly Adjustable®) or a calf muscle eccentric exercise program.

Primary and secondary measures will be collected at baseline and at 2, 6 and 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. Secondary measures will include Achilles tendon structure (assessed using ultrasound imaging), calf muscle function, self-reported global change in symptoms, severity of pain at the Achilles tendon during the previous week, self-reported physical activity, health-related quality of life, as well as use of paracetamol rescue medication and co-interventions.
Trial website
www.achillespainstudy.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77010 0
A/Prof Shannon Munteanu
Address 77010 0
Discipline of Podiatry
School of Allied Health
La Trobe University
Melbourne
VIC 3086
Country 77010 0
Australia
Phone 77010 0
+61 3 9479 5866
Fax 77010 0
Email 77010 0
s.munteanu@latrobe.edu.au
Contact person for public queries
Name 77011 0
Ms Chantel Rabusin
Address 77011 0
Discipline of Podiatry
School of Allied Health
La Trobe University
Melbourne
VIC 3086
Country 77011 0
Australia
Phone 77011 0
+61 3 9479 2166
Fax 77011 0
Email 77011 0
c.rabusin@latrobe.edu.au
Contact person for scientific queries
Name 77012 0
A/Prof Shannon Munteanu
Address 77012 0
Discipline of Podiatry
School of Allied Health
La Trobe University
Melbourne
VIC 3086
Country 77012 0
Australia
Phone 77012 0
+61 3 9479 5866
Fax 77012 0
Email 77012 0
s.munteanu@latrobe.edu.au

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