Shockwave therapy and ultrasound therapy for chronic patellar tendinopathy

• Register: ANZCTR
• Last refreshed on: 27 February 2023
• Main ID: ACTRN12618000714280
• Date of registration: 01/05/2018
• Prospective Registration: Yes
• Primary sponsor: The Jerzy Kukuczka Academy of Physical Education
• 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
• Date of first enrolment: 01/08/2018
• Target sample size: 36
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12618000714280.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;
• Phase: Not Applicable

Countries of recruitment

Poland

Contacts

• Name: Mrs Stania Magdalena

• Name: Mrs Stania Magdalena

Key inclusion & exclusion criteria

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

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)


Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Other muscular and skeletal disorders

Physical Medicine / Rehabilitation - Physiotherapy

Patellar tendinopathy ;
Patellar tendinopathy

Intervention(s)

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

Primary Outcome(s)

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. [The assessment will be taken prior to therapy and at 1, 6 (primary endpoint), and 24 weeks post therapy completion. ]

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.[The assessment will be taken prior to therapy and at 1, 6 (primary endpoint), and 24 weeks post therapy completion. ]

Secondary Outcome(s)

- subjective 4-point assessment of pain and limitations of activity after therapy (Roles and Maudsley score).
[The assessment will be taken prior to therapy and at 1, 6, and 24 weeks post therapy completion. ]

Therapy effect will also be evaluated based on:
- Visual Analogue Scale for Pain (VAS)

[The assessment will be taken prior to therapy and at 1, 6, and 24 weeks post therapy completion. ]

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.
[The assessment will be taken prior to therapy and at 1, 6, and 24 weeks post therapy completion. ]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

The Jerzy Kukuczka Academy of Physical Education

Ethics review

Status: Approved
Approval date: 10/03/2016
Contact:

The Research Ethics Committee from The Jerzy Kukuczka Academy of Physical Education in Katowice