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Trial registered on ANZCTR


Registration number
ACTRN12617000860369
Ethics application status
Approved
Date submitted
16/05/2017
Date registered
9/06/2017
Date last updated
5/07/2022
Date data sharing statement initially provided
27/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Shockwave therapy and ultrasound therapy for chronic Achilles tendinopathy
Scientific title
Objective and subjective assessment of the efficacy of radial shock wave therapy and sonotherapy in Achilles tendinopathy
Secondary ID [1] 291914 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles tendinopathy 303232 0
Condition category
Condition code
Musculoskeletal 302660 302660 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 302661 302661 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main aim of the study is to assess the efficacy of radial shock wave and ultrasound therapies for Achilles tendinopathy. Patients diagnosed with Achilles tendinopathy will be randomly allocated to one of three experimental groups:
Group A: radial shock wave therapy
Group B: ultrasound therapy
Group C: placebo ultrasound
Group A - radial shock waves will be applied without local aesthesia using ShockMaster 500 (Gymna-Uniphy) with a pneumatic applicator. A gel will be applied on the patient’s skin in the target area to help conduct the shock waves. The patient will be positioned prone with a roll under ankles and foot dorsiflexion.

Applicator: standard 15 mm applicator, D-Actor vibration applicator.
Pressure: 2.5 – 4.0 bars.
Number of shocks: 2000-6000.
Frequency: 4 – 15 Hz.
Number of therapy sessions: 3 (duration of intersession break 4-10 days).
Duration of each session: approximately 7-10 minutes

Group B - sonotherapy will be performed with a device for ultrasound applications – Pulson 400(Gymna). The skin will be coated with a coupling agent, ie., ultrasound gel. The patient will be positioned prone with a roll under the ankles.

Tranducer head size: 4 cm^2.
Ultrasound frequency: 3 MHz.
Ultrasound power density (spatial average of the density): 0.1 – 1.5 W/cm^2.
Pulse ratio (duty cycle): 25 – 100 %.
The duration of a therapy session will depend on the size of the treatment area – each square centimeter will be exposed to ultrasonic energy for 1 to 2.5 minutes.
Frequency of therapy sessions: everyday, five days a week (except for Saturday and Sunday).
Number of therapy sessions: 10.
Duration of each session: approximately 7-10 minutes

The parameters of the treatment in Group A and in Group B were determined based on our own clinical experience and reasoning, literature review (Val Robertson et al.: Electrotherapy Explained, Principles and Practice, 4th Edition, Elsevier; Król Piotr & Franek Andrzej: Fala uderzeniowa w leczeniu dysfunkcji ukladu narzadów ruchu, Meden 2014) and general principles of application of physical modalities.

Group C– quasi sonotherapy will be performed with Pulson 400 (Gymna). The skin will be coated with a coupling agent, ie., ultrasound gel. The patient will be positioned prone with a roll under ankles.
All ultrasound device parameters and therapy procedures will be identical as in Group B except that the transducerwill not generate sound waves. The number of therapy sessions will be 10.

During the first two weeks of the therapy, all study groups will also undergo deep friction massage.

The following measurements will be performed to objectively assess therapy effects:
I. Stabilography will be carried out using 2 AMTI AccuSway platforms with integrated sensors to register ground reaction forces and the horizontal torque applied by the subject’s feet.
A two-platform test (Platforms A and B) will consist of 7 trials:
a/ Quiet standing with one foot resting on Platform A and the other on Platform B situated next to Platform A. Two 60-second trials in a quiet standing position will be recorded for each of the two testing conditions: eyes open and eyes closed.
b/ Two lean-forward trials to the limits of stability (LOS) with movement at the ankles only. The protocol of LOS will consist of three phases: Phase 1 – 10s of quiet standing (quiet standing with one foot resting on Platform A and the other on Platform B situated next to Platform A); Phase 2 – the maximal forward-lean in a self-paced manner; Phase 3 – maintenance of the maximal forward-lean.
c/ Two lean-backward trials to the limits of stability (LOS) with movement at the ankles only. The protocol of LOS will consist of three phases: Phase 1 – 10s of quiet standing (quiet standing with one foot resting on Platform A and the other on Platform B situated next to Platform A); Phase 2 – the maximal backward-lean in a self-paced manner; Phase 3 – maintenance of the maximal backward-lean.

The step initiation's tests:
d/ Three repetitions: quiet standing on platform A for 15 seconds, then changing to Platform B (1 step) followed by quiet standing for another 15 seconds. The distance between platforms: 10cm.
e/ Three repetitions:quiet standing on Platform A for 15 seconds, then changing to Platform B (1 step) followed by quiet standing for another 15 seconds. A 15-cm obstacle over the edge of the platforms; the distance between platforms: 10 cm.
f/ Three repetitions – quiet standing on Platform A for 15 seconds, then changing to Platform B (1 step up) followed by quiet standing for another 15 seconds. Platform B is placed on a 17-cm base directly at the edge of Platform A.
g/ Three repetitions – quiet standing on Platform B for 15 seconds, then changing to Platform A (1 step down) followed by quiet standing for another 15 seconds. Platform B is placed on a 17-cm base directly at the edge of Platform A.
The step initiation's tests: The recording of COP displacements will be divided into three phases:
Phase 1 – quiet standing before step initiation
Phase 2 – transit
Phase 3 – quiet standing until measurement completion.
The recording will be divided into phases using an algorithm whose main elements will be foot contact with the platform and the limit of momentary COP displacement; beyond that point exit from stability or stability gain will be observed. Stability is defined as body sway where momentary COP displacement does not exceed average COP displacement plus three standard deviations. For Phase 1, average COP and SD will be calculated based on measurements made within the first 5 sec of the test. For Phase 3 – based on the last 5 sec of the test.

Platform changing will each time start at a sound signal. The procedure of step initiation will be performed twice to make sure that each trial is initiated using alternate limbs.

II. Vertical jump (without an arm swing) measurements will be taken on an AMTI AccuSway platform.
The following trials will be performed:
- countermovement jump (starting position: quiet standing) ,
- squat jump (starting position: knees flexed to 90°).
In each of the above trials the patients will perform three maximal jumps and three sub-maximal jumps (approximately 50% of the maximum height).
- muscle stiffness test: five maximal countermovement jumps in a row without an arm-swing, with a minimum bend at lower limb joints.

Posturographic measurements, countermovement jump quantification, forward body lean and subjective assessment will be taken prior to therapy and at 1, 6, and 24 weeks of therapy completion.
Intervention code [1] 298036 0
Rehabilitation
Intervention code [2] 298242 0
Treatment: Devices
Comparator / control treatment
All ultrasound device parameters and therapy procedures in Group C – quasi sonotherapy will be identical as in Group B except that the transducer will not generate sound waves.
Control group
Placebo

Outcomes
Primary outcome [1] 302131 0
This is a composite outcome. Step initiation / making steps under different conditions (with and without an obstacle, stepping up onto a platform situated at a higher level, stepping down onto a platform situated on a lower level).
The following will be determined:
-Center of Pressure (COP) displacement, ie., mean COP, path and velocity of COP signal;
-D1 – time from exit from stability state until the foot resting on the other platform
-D2– time from raising the foot from the first platform until gaining stability on the other platform
-double-support period (DSP) – foot contact with both platforms
-Transit time (Phase 2) – time from exit from stability state until gaining post-transit stability; the sum of D1 + DSP + D2
-Step length – distance between double-support site on each platform
This outcome will assessed using AMTI platform and Matlab software.
Timepoint [1] 302131 0
The assessment will be taken prior to therapy and at 1, 6, and 24 weeks of therapy completion.
Primary outcome [2] 302101 0
This is a composite outcome.
Measurement parameters of limits of stability (LOS):
-mean value of Center of Pressure (COP) anterior -posterior (AP) position with appropriate index denoting the phase of trial (1, 2 or 3)
-range (R) – position of COP between the maximal and minimal positions in AP plane in each specific phase 1 (R1), 2 (R2), 3 (R3)
This outcome will assessed using AMTI platform and Matlab software.
Timepoint [2] 302101 0
The assessment will be taken prior to therapy and at 1, 6, and 24 weeks of therapy completion.
Primary outcome [3] 302132 0
This is a composite outcome of measurement parameters of .countermovement jump, squat jump and muscle stiffness tests:
- countermovement jump test:
jump height [cm], flight time [s], index of force differentiation error
- squat jump test:
jump height [cm], flight time [s], index of force differentiation error
- muscle stiffness test:
K - vertical stiffness [N/m]
KrealF– vertical stiffness calculated from platform measurements
KmodelF – vertical stiffness calculated from flight time and physical model
VtoffR– take-off velocity based on real dynamograph [m/s]
VtoffM – take-off velocity based on flight time and physical model [m/s]
Tflight – flight time [s]
modelFmax – maximum model value of the vertical ground reaction forces component [N]
realFmax – maximum value of the vertical ground reaction forces component [N]
dLmodel- centre of mass (COM) lowering (countermovement jump depth) based on model ground reaction forces – [m]
dLreal – centre of mass (COM) lowering (countermovement jump depth)based on real ground reaction forces recording [m]
This outcome will assessed using AMTI platform and Matlab software.
Timepoint [3] 302132 0
The assessment will be taken prior to therapy and at 1, 6, and 24 weeks of therapy completion.
Secondary outcome [1] 335583 0
- subjective 4-point assessment of pain and limitations of activity after therapy (Roles and Maudsley score).
Timepoint [1] 335583 0
The assessment will be taken prior to therapy and at 1, 6, and 24 weeks of therapy completion.
Secondary outcome [2] 334904 0
This is a composite outcome of COP signal in a quiet standing position.
The measurements of rambling (RM) trajectory :
-Range, path length, root mean square, standard deviation , velocity,

The measurements of trembling (TR) trajectory
-range, path length, root mean square, standard deviation, and velocity.
All calculations will be made for anterior- posterior (AP) and medial-lateral (ML) directions.
This outcome will assessed using AMTI platform and Matlab software.
Timepoint [2] 334904 0
The assessment will be taken prior to therapy and at 1, 6, and 24 weeks of therapy completion.
Secondary outcome [3] 334781 0
Therapy effect will also be evaluated based on:
- Visual Analogue Scale for Pain (VAS)
Timepoint [3] 334781 0
The assessment will be taken prior to therapy and at 1, 6, and 24 weeks of therapy completion.
Secondary outcome [4] 335582 0
- VISA-A function score (Victorian Institute of Sport Assessment Achilles questionnaire)
Timepoint [4] 335582 0
The assessment will be taken prior to therapy and at 1, 6, and 24 weeks of therapy completion.

Eligibility
Key inclusion criteria
- symptoms of pain of the Achilles tendon over 3 months duration
- tendon abnormalities identified on ultrasound
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- candidates under 18 years of age
- pregnancy
- thrombophlebitis
- atherosclerosis
- renal failure
- local lower limb infection
- neoplastic disease
- history of Achilles tendon surgery
- knee instability
- ankle instability
- lower extremity length discrepancy
- lower extremity cellulitis
- anticoagulant therapy
- physical therapy during 6 weeks preceding the study
- corticosteroid injections during 6 weeks preceding the study
- type 1 diabetes mellitus and type 2 diabetes mellitus with insulin therapy
- rheumatoid arthritis and other rheumatoid disease
- cardiac pacemaker
- cardiac arrhythmia
- cardiovascular insufficiency
- patellar tendinitis
- bilateral Achilles tendinopathy
- history of stroke (ischemic, hemorrhagic)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Determination of sample size

We assum the probability of a type I error a = 0.05, target power of 1-beta = 0.80 and a 25% minimum significant difference between the means of parameters studied. The resultant minimum sample size is 12 patients. The target sample size is 36; 3 additional participants will be recruited to account for dropouts. The study participants will be randomly assigned to 3 groups. Data analysis will be performed with Statistica, version 10.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
11/10/2017
Date of last participant enrolment
Anticipated
25/02/2022
Actual
7/03/2022
Date of last data collection
Anticipated
31/08/2022
Actual
2/05/2022
Sample size
Target
36
Accrual to date
Final
39
Recruitment outside Australia
Country [1] 8899 0
Poland
State/province [1] 8899 0

Funding & Sponsors
Funding source category [1] 296419 0
University
Name [1] 296419 0
The Jerzy Kukuczka Academy of Physical Education
Country [1] 296419 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education
Address
Mikolowska 72, 40-065 Katowice, Poland
Country
Poland
Secondary sponsor category [1] 295363 0
None
Name [1] 295363 0
None
Address [1] 295363 0
None
Country [1] 295363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297645 0
The Research Ethics Committee from The Jerzy Kukuczka Academy of Physical Education in Katowice
Ethics committee address [1] 297645 0
Ethics committee country [1] 297645 0
Poland
Date submitted for ethics approval [1] 297645 0
Approval date [1] 297645 0
10/03/2016
Ethics approval number [1] 297645 0
5/2016

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

Contacts
Principal investigator
Name 74694 0
Mrs Stania Magdalena
Address 74694 0
Department of Physical Therapy, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 74694 0
Poland
Phone 74694 0
+48694979640
Fax 74694 0
Email 74694 0
m.stania@awf.katowice.pl
Contact person for public queries
Name 74695 0
Stania Magdalena
Address 74695 0
Department of Physical Therapy, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 74695 0
Poland
Phone 74695 0
+48694979640
Fax 74695 0
Email 74695 0
m.stania@awf.katowice.pl
Contact person for scientific queries
Name 74696 0
Stania Magdalena
Address 74696 0
Department of Physical Therapy, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 74696 0
Poland
Phone 74696 0
+48694979640
Fax 74696 0
Email 74696 0
m.stania@awf.katowice.pl

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
SourceTitleYear of PublicationDOI
EmbaseAnalysis of pain intensity and postural control for assessing the efficacy of shock wave therapy and sonotherapy in Achilles tendinopathy - A randomized controlled trial.2023https://dx.doi.org/10.1016/j.clinbiomech.2022.105830
N.B. These documents automatically identified may not have been verified by the study sponsor.