Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000714280
Ethics application status
Approved
Date submitted
3/03/2018
Date registered
1/05/2018
Date last updated
13/10/2024
Date data sharing statement initially provided
28/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Shockwave therapy and ultrasound therapy for chronic patellar tendinopathy
Scientific title
Objective and subjective assessment of the efficacy of radial shock wave therapy and sonotherapy in patellar tendinopathy
Secondary ID [1] 294221 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellar tendinopathy 306884 0
Condition category
Condition code
Musculoskeletal 305982 305982 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 305983 305983 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 patellar tendinopathy . Patients diagnosed with patellar 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 anesthesia 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. Shockwave therapy will be applied at the patellar ligament extending from the apex of the patella to the tibial tuberosity. The patient will be positioned supine with a roll under the knees.
Applicator: standard 15 mm applicator, D-Actor vibration applicator.
Pressure: 2.5 bars
Number of shocks: 3000
Frequency: 8 Hz.
Number of therapy sessions: 3 (duration of intersession break 4-10 days).
Duration of each session: approximately 5-7 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 supine with a roll under the knees.

Tranducer head size: 4 cm^2.
Ultrasound frequency: 3 MHz.
Ultrasound power density (spatial average of the density): 1 W/cm^2.
Pulse ratio (duty cycle): 50 %.
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.

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.

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.

The diagnosis of patellar tendinopathy will be made by an orthopedic surgeon. Shockwave and ultrasound therapy will be carried out by a physiotherapist. Posturography tests, vertical jump measurements and questionnaire survey will be conducted by another therapist.
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.

There are no plans to assess fidelity or adherence, or strategies to promote adherence or fidelity.

Intervention code [1] 300513 0
Rehabilitation
Intervention code [2] 300514 0
Treatment: Devices
Comparator / control treatment
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 supine with a roll under the knees.
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.
Control group
Placebo

Outcomes
Primary outcome [1] 305017 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 [1] 305017 0
The assessment will be taken prior to therapy and at 1, 6 (primary endpoint), and 24 weeks post therapy completion.
Primary outcome [2] 305018 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 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.

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 [2] 305018 0
The assessment will be taken prior to therapy and at 1, 6 (primary endpoint), and 24 weeks post therapy completion.
Secondary outcome [1] 343900 0
Therapy effect will also be evaluated based on:
- Visual Analogue Scale for Pain (VAS)

Timepoint [1] 343900 0
The assessment will be taken prior to therapy and at 1, 6, and 24 weeks post therapy completion.
Secondary outcome [2] 343901 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] 343901 0
The assessment will be taken prior to therapy and at 1, 6, and 24 weeks post therapy completion.
Secondary outcome [3] 343902 0
- subjective 4-point assessment of pain and limitations of activity after therapy (Roles and Maudsley score).
Timepoint [3] 343902 0
The assessment will be taken prior to therapy and at 1, 6, and 24 weeks post therapy completion.

Eligibility
Key inclusion criteria
- symptoms of over 3 months duration
- pain on palpation of the apex of the patella
- pain provoked by knee extension against resistance
- abnormalities within the proximal insertion of the patellar tendon 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 patellar tendon repair
-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
-Achilles tendinopathy
-bilateral patellar tendon enthesopathy
-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 per group. 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
Recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
1/08/2018
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
2/01/2026
Actual
Sample size
Target
36
Accrual to date
29
Final
Recruitment outside Australia
Country [1] 9645 0
Poland
State/province [1] 9645 0
Silesia

Funding & Sponsors
Funding source category [1] 298858 0
University
Name [1] 298858 0
The Jerzy Kukuczka Academy of Physical Education
Country [1] 298858 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] 298069 0
None
Name [1] 298069 0
None
Address [1] 298069 0
None
Country [1] 298069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299804 0
The Research Ethics Committee from The Jerzy Kukuczka Academy of Physical Education in Katowice
Ethics committee address [1] 299804 0
Ethics committee country [1] 299804 0
Poland
Date submitted for ethics approval [1] 299804 0
Approval date [1] 299804 0
10/03/2016
Ethics approval number [1] 299804 0
5/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2472 2472 0 0
/AnzctrAttachments/374638-CCE20170726_0002.pdf (Ethics approval)

Contacts
Principal investigator
Name 81610 0
Mr Król Piotr
Address 81610 0
Department of Physical Therapy, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 81610 0
Poland
Phone 81610 0
+48606628989
Fax 81610 0
Email 81610 0
[email protected]
Contact person for public queries
Name 81611 0
Stania Magdalena
Address 81611 0
Department of Physical Therapy, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 81611 0
Poland
Phone 81611 0
+48694979640
Fax 81611 0
Email 81611 0
[email protected]
Contact person for scientific queries
Name 81612 0
Stania Magdalena
Address 81612 0
Department of Physical Therapy, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 81612 0
Poland
Phone 81612 0
+48694979640
Fax 81612 0
Email 81612 0
[email protected]

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.