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Trial registered on ANZCTR


Registration number
ACTRN12620000035921
Ethics application status
Approved
Date submitted
14/11/2019
Date registered
21/01/2020
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of radial shockwave therapy compared with sham shockwave therapy in insertional Achilles tendinopathy. A randomised controlled trial
Scientific title
The efficacy of radial shockwave therapy compared with sham shockwave therapy in insertional Achilles tendinopathy. A randomised controlled trial
Secondary ID [1] 299679 0
None
Universal Trial Number (UTN)
U1111-1242-7822
Trial acronym
ERASE

The Efficacy of RadiAl ShockwavE therapy compared with sham shockwave therapy in insertional Achilles tendinopathy. A randomised controlled trial
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Tendinopathy 315029 0
Condition category
Condition code
Physical Medicine / Rehabilitation 313361 313361 0 0
Physiotherapy
Musculoskeletal 313955 313955 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Radial shockwave therapy (rSWT): rSWT will be administered by an adequately trained physiotherapist. The participant will receive a 3000-shock dose of rSWT (Chattanooga device) applied to the most painful area on the affected side Achilles tendon. Gel will be used to conduct pressure waves to the tendon. Intensity of application will start on two bars of pressure, with frequency set to continuous and eight per second. The target self-reported pain will be >4/10 until the highest tolerable pain (numerical pain rating scale, 0=no pain, 10=worst pain imaginable). If self-reported pain drops below 5/10 the rSWT probe will be moved to a different region within the region of interest (area 2cm squared surrounding the starting location). If the pain remains below 5/10 at all parts within the region of interest the rSWT pressure setting will be progressed from two bar of pressure (this will always be the starting point) up to and including five bar of pressure (the maximum in the machine being used) so as to achieve the desired self-reported pain output. This process will be repeated as necessary until the shock dose of 3000 is completed (at 10 Hz, so the treatment lasts for 5 minutes). Participants will receive an identical rSWT treatment on three occasions (baseline, and approx. week 1 and 2), each separated by a approximaly 7 days (minimum 5 days and maximum 10 days).

Post rSWT treatment:
Immediately after the rSWT, participants will be asked whether they believe they were in the intervention or placebo group.

After that, an appropriately trained researcher, who is blind to treatment allocation will deliver advice and a 12-week exercise program to all participants. This includes an evidence-based and progressively loaded exercise protocol for Achilles tendinopathy, education about physical activity modification and resumption, and advice about progressing and regressing exercise load, based on a pain monitoring model. The researcher will also provide education about Achilles tendinopathy (pathology, pain, risk factors, prognosis, treatments, recovery times). Participants will be reviewed by the researcher at Imaging at Olympic Park (IOP) at weeks 1 and 2 weeks (when repeat shockwave is applied) to modify the exercise as required (e.g. progress load, modify technique). The researcher will have a teleconference (Zoom) meeting with participants at week 6 to ask whether they have any questions or issues with the exercise or education intervention. Additionally, participants will be provided with basic online exercise videos and education and the researchers contact details that they can use at any time. Participants will be advised to refrain from using other physical therapy interventions and non-steroidal anti-inflammatory medications but will be advised to take paracetamol (up to 4g/day) for pain relief as required.

Details of the exercise program:
a) who is administering the program: physiotherapist (@ baseline with further progressions and guidance @ 1, 2 weeks, and zoom support at 6 weeks). ie participants will be followed up @ 5 weeks via Zoom. Participants will also be sent a weekly email encouraging them to complete the exercises and report any issues they may be having (if they express they are having issues a researcher will call them to discuss)
b) the mode of administration: independently at home.
c) the level of intensity: will be adjusted by the participants themselves based on pain and repetitions in reserve. They will be advised to do 15 repetitions x 4 sets, once a day for three times a week. If they experience less than 5/10 pain and have 2 reps in reserve, then they will be advised to add weights in 5kgs increments. If pain is >5/10 they will be advised to revert to an isometric version of the exercise
d) the frequency/duration of program, 15 repetitions x 4 sets, once a day for three times a week for 12 weeks.
e) the exercises include standing knee straight and knee bent isotonic (eccentric and conentric) calf raises
f) exercise progression: Participants will progress and regress exercise themselves based on criteria outlined above. They will also be reviewed by the researcher at Imaging at Olympic Park (IOP) at 1 and 2 weeks to administer subsequent rSWT sessions and to modify the exercise as required (e.g. progress load, modify technique). There will also be a brief Zoom session at 6 weeks to check progress, check exercises and provide advice.

Details of the education program:
a) who administers the education: physiotherapist (@ baseline with further reinforcement and guidance @ 1, 2 weeks, and a Zoom meeting at 6 weeks, as well as weekly email support [opportunity to ask questions and voice concerns])
b) the mode of administration: Face to face supported by videos and education leaflets.
c) the frequency/duration of program: 12 weeks. single session at the beginning of the program and then with further reinforcement and guidance @ week 6 via a Zoom meeting and weekly email support).
d) the education program will be delieverd in 15-20 minutes in the first session.

Strategies to monitor adherence: adherence will be assessed via self report questionnaire at 6 and 12 weeks (via email or text link to a Qualtrics survey).
Intervention code [1] 315944 0
Treatment: Devices
Intervention code [2] 316373 0
Treatment: Other
Comparator / control treatment
Sham rSWT: This procedure is identical to the rSWT, but without any pressure waves entering the body and without the production of a pain response. The sham rSWT device will appear and sound identical to the active rSWT device.. All other aspects of the intervention including follow-up sessions, 6 week Zoom meeting, weekly email support and the exercise and education interventions will be identical in both groups.
Control group
Placebo

Outcomes
Primary outcome [1] 321840 0
Pain and function will be assessed with VISA-A score (this is a composite instriment measuring both pain and function). The VISA-A is a disease specific and validated tool for assessing Achilles tendon pain and function.
Timepoint [1] 321840 0
baseline in person and 6 and 12 (primary endpoint) weeks via email or text link to online questionnaire.
Primary outcome [2] 321841 0
Global rating of change measured with the the Global Rating of Change Scale (GROC). The GROC is an 11-point scale where participants rate perceived change in their condition. The categories include Worse, No Change, or Better. If they indicate worse or better they are asked to quantify this on a 5 point scale from Slightly Better/Worse to Very Much Better/Worse.
Timepoint [2] 321841 0
baseline in person and 6 and 12 (primary endpoint) weeks via email or text link to online questionnaire
Secondary outcome [1] 376501 0
Mechanosensory sensitivity measured using pressure pain threshold at the site of rSWT application (most affected insertional Achilles tendon) and the opposite elbow. This outcome will be collected pre and post each shockwave session. A pressure algometer is used to measure pressure pain threshold.
Timepoint [1] 376501 0
Baseline, week 1 and week 2 (before and after each rSWT session)
Secondary outcome [2] 376502 0
Pain with a standardised loading protocol reported on a 100 mm visual analogue scale (zero = no pain; 100 = worst pain possible). Participants will perform 3 single leg calf raises over a step (1 second up and 1 second down, in time with a metronome) and 5 single leg hops (in time with metronome set at 120 bpm [2 hops per second]) in a randomised order. These measures will be assessed (in a randomised order) pre and post rSWT application at baseline, week 1 and 2, as well as self reported by patients everyday for 7 days post rSWT application. For self report measures, participants will be asked to perform the tasks in a random order at the same time (10 to 11am) everyday.
Timepoint [2] 376502 0
Baseline, week 1 and week 2 (before and after each rSWT session) via face to face, and self-reported and recorded by participants for 7 consecutive days following each rSWT application.
Secondary outcome [3] 376503 0
Overall pain intensity last 24 hours: Measured using the 100 mm visual analogue scale (VAS), participants will rate the worst pain during the last 24 hours (zero = no pain; 100 = worst pain possible).
Timepoint [3] 376503 0
a/ Baseline, week 1 and week 2 (before each rSWT session) face to face
b/ Week 6 and 12 via email or text link to online questionnaire
b/ Self-reported and recorded by participants for 7 consecutive days following each rSWT application.
Secondary outcome [4] 376504 0
Health-related quality of life: Measured with the EuroQol 5D-5L which is a composite outcome measuring five domains AND overall health. The EuroQol 5D-5L is a validated and reliable tool, including five domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), and a rating of overall health state from 0 (worst health state imaginable) to 100 (best imaginable health state) using a VAS.
Timepoint [4] 376504 0
baseline in person and 6 and 12 weeks via email or text link to online questionnaire
Secondary outcome [5] 376505 0
The level of physical activity in the previous week: Evaluated using the 7-day Recall Physical Activity Questionnaire, a valid and reliable tool. Participants will be asked to recall time spent sleeping and doing physical activity (work, leisure, household activities) over the past 7 days.
Timepoint [5] 376505 0
baseline in person and 6 and 12 weeks via email or text link to online questionnaire
Secondary outcome [6] 376506 0
Fear avoidance: The Tampa Kinesiophobia Scale is a validated questionnaire used to measure fear-avoidance.
Timepoint [6] 376506 0
baseline in person and 6 and 12 weeks via email or text link to online questionnaire
Secondary outcome [7] 376507 0
Pain self efficacy: Assessed with the pain self-efficacy questionnaire (PSEQ). The PSEQ measures how confident a patient is in undertaking a range of activities despite their pain
Timepoint [7] 376507 0
baseline in person and 6 and 12 weeks via email or text link to online questionnaire
Secondary outcome [8] 376508 0
Adverse events over the last 6 weeks: An adverse event is defined as any unfavourable or unintended diagnosis, sign, symptom, or disease associated with the study which may or may not be related to the intervention (e.g. tendon rupture, fall, injury, or change in medical status). It will be measured using an Adverse events questionnaire, which was designed specifically for this study.
Timepoint [8] 376508 0
6 and 12 weeks via email or text link to online questionnaire
Secondary outcome [9] 376509 0
Catastrophising: The Pain Catastrophising Scale is a validated questionnaire used to measure pain catastrophisation.
Timepoint [9] 376509 0
baseline in person and 6 and 12 weeks via email or text link to online questionnaire
Secondary outcome [10] 376510 0
Exercise adherence: Participants will record the number of exercise sessions completed each week over the previous six weeks (adherence is the percentage of prescribed sessions that are completed)
Timepoint [10] 376510 0
6 and 12 weeks via email or text link to online questionnaire
Secondary outcome [11] 376513 0
Healthcare use: Participants will be asked to answer yes or no to whether they have used any health services or co-interventions over the last 6 weeks. if they answer yes details will becollected via a follow up telephone call.
Timepoint [11] 376513 0
6 and 12 weeks via email or text link to online questionnaire
Secondary outcome [12] 376514 0
Productivity (including absenteeism and presentism) will be measured using the ‘iMTA Productivity Cost Questionnaire’
Timepoint [12] 376514 0
baseline in person and 6 and 12 weeks via email or text link to online questionnaire

Eligibility
Key inclusion criteria
Aged 18 years or older
>3 months of pain at the insertion of the Achilles to the posterior calcaneal surface
Primary complaint of insertional Achilles pain on one or both lower limbs
Clinical diagnosis of insertional Achilles tendinopathy based on the following criteria:
o Gradual onset pain in the relevant area;
o Pain during or after Achilles tendon loading activities (e.g. walking, running)
Ankle joint examination is normal and passive plantar-flexion is painfree;
Confirm diagnosis with ultrasound imaging of the Achilles tendon. One or more of the following features present in the insertion area: (i) thickening of the anteroposterior tendon insertion; and/or (ii) hypoechoic regions with or without thickening/fluid within the retrocalcaneal bursa
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Previous rSWT treatment for any condition
• Previous Achilles tendon surgery in the most symptomatic Achilles tendon
• Previous Achilles tendon rupture in the most symptomatic Achilles tendon
• Other ankle conditions including impingement syndrome or any midportion Achilles symptoms that are worse than the insertional Achilles pain
• Tendinopathy caused by inflammatory conditions (e.g. ankylosing spondylitis)
• Neurological disorders (i.e. Parkinson’s syndrome, stroke)
• Inherited connective tissue disorders (i.e. Ehlers- Danlos syndrome, Marfan’s syndrome)
• Use of fluoroquinolone antibiotics within the previous two years
• Injection of local anaesthetic, corticosteroid, platelet rich plasma or other pharmaceutical agent into the Achilles tendon or surrounding area within the previous three months
• Any medical and/or social reason that, in the opinion of the investigators, makes the participant unsuitable for inclusion
• Serious mental health problem that would preclude adherence to study or treatment protocols

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 concealement will be achieved via sequentially numbered opaque envelopes containing the randomisation sequence. The envelopes will be created by an independent researcher not based at the trial site or involved in any data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
-Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
-Permuted block randomisation
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)
Statistical methods / analysis
A Statistical Analysis Plan (SAP) will be completed. In participants with bilateral symptoms, the most painful side will be analysed (or the right foot if they cannot define the more painful foot) to maintain independence of data. Statistical tests will be two-tailed with statistical significance level set at 0.05. All randomised patients will be included in the analysis (i.e. intention-to-treat) for primary and secondary outcomes (except for safety outcomes). Demographic characteristics (e.g. age, gender) and other baseline measurements (e.g. duration of symptoms) will be reported by treatment arm. Between group differences in the primary and secondary outcomes measures will be compared at 6 and 12 weeks, with the primary outcome being at 12 weeks. Continuously-scored outcome measures will be analysed using linear mixed models with adjustments for baseline scores and variables that influence the outcome (e.g. age). Ordinal scaled data will be analysed using non-parametric tests and modelled with proportional odds regression adjusted for repeated assessment of subjects. Dichotomous scaled outcome measures will be compared using relative risk, risk difference, and number needed to treat (NNT) using generalised estimating equations. Sensitivity to missing data will be assessed using multiple imputation models incorporating predictive baseline and post-baseline variables.

Change in PPT, overall pain and pain with loading will be investigated pre-post rSWT and for 7-days following rSWT (ANOVA, with time as within-subject and group as between subject factors).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304155 0
Commercial sector/Industry
Name [1] 304155 0
DJO Global
Address [1] 304155 0
2900 Lake Vista Drive
Lewisville, TX 75067
DJO Global
Country [1] 304155 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Monash University Peninsula Campus, Building B, Franston, Victoria, Moorooduc Hwy, Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 304528 0
None
Name [1] 304528 0
None
Address [1] 304528 0
None
Country [1] 304528 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304634 0
Monash University Human Ethics Committee
Ethics committee address [1] 304634 0
Monash University, Wellington Rd, Clayton VIC 3800
Ethics committee country [1] 304634 0
Australia
Date submitted for ethics approval [1] 304634 0
02/08/2019
Approval date [1] 304634 0
04/09/2019
Ethics approval number [1] 304634 0
21015

Summary
Brief summary
Achilles tendinopathy is a common, painful and disabling musculoskeletal condition. There is a treatment called radial shockwave therapy (rSWT) that produces a pressure wave that enters the Achilles tendon. Some studies report positive findings for this treatment in insertional Achilles tendinopathy but it is not certain whether rSWT is better than placebo. The proposed study is a two-arm, parallel group, double-blind randomised prospective trial. Participants will be block-randomised into sham rSWT or rSWT groups with a 1:1 ratio. All participants will receive weekly rSWT (sham rSWT or rSWT) once per week over a three-week period, and will also receive an identical evidence-based exercise intervention to be completed for the duration of the trial, which removes ethical concerns of withholding treatment. Participants and outcome assessors will be blinded to treatment allocation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97662 0
A/Prof Peter Malliaras
Address 97662 0
Monash University Peninsula Campus, Building B, Franston, Victoria, Moorooduc Hwy, Frankston VIC 3199
Country 97662 0
Australia
Phone 97662 0
+61400206480
Fax 97662 0
Email 97662 0
peter.malliaras@monash.edu
Contact person for public queries
Name 97663 0
A/Prof Peter Malliaras
Address 97663 0
Monash University Peninsula Campus, Building B, Franston, Victoria, Moorooduc Hwy, Frankston VIC 3199
Country 97663 0
Australia
Phone 97663 0
+61400206480
Fax 97663 0
Email 97663 0
peter.malliaras@monash.edu
Contact person for scientific queries
Name 97664 0
A/Prof Peter Malliaras
Address 97664 0
Monash University Peninsula Campus, Building B, Franston, Victoria, Moorooduc Hwy, Frankston VIC 3199
Country 97664 0
Australia
Phone 97664 0
+61400206480
Fax 97664 0
Email 97664 0
peter.malliaras@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All outcome data
When will data be available (start and end dates)?
After the end of data analysis, so after Sept 2020 (for a period of 5 years)
Available to whom?
Upon request. Data will be shared with researchers who provide a sound methodological proposal (e.g. protocol for a systematic review).
Available for what types of analyses?
Systematic review
How or where can data be obtained?
Upon request by emailing the principal investigator (Peter.malliaras@monash.edu). Data will be emailed to the requesting researchers.
What supporting documents are/will be available?
No other documents available
Summary results
No Results