Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000651482
Ethics application status
Approved
Date submitted
22/05/2025
Date registered
19/06/2025
Date last updated
19/06/2025
Date data sharing statement initially provided
19/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does combining shock wave therapy and vibration help with Achilles tendinopathy?
Scientific title
Evaluation of the Therapeutic Effectiveness of Combined Radial Shock Wave Therapy and Local Vibration in Patients with Achilles Tendinopathy
Secondary ID [1] 314515 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles tendinopathy 337594 0
Condition category
Condition code
Musculoskeletal 333940 333940 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 333941 333941 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Local Vibration

Local vibration treatments will be performed using the Storz Medical Duolith SD1 device with the V25 vibration transmitter (Ø 25 mm). In patients with significant body hair, the skin surface where the treatment will be applied will be covered with gel prior to the procedure.

The patient will be positioned lying prone with a bolster placed under the ankles. The foot will be positioned in dorsiflexion. During the treatment, both bellies of the gastrocnemius muscle will be dynamically stimulated. The following parameters will be applied:

Vibration frequency: 30 Hz
Pressure: 3 bar
Number of vibrations: 2,000 (Hyo Jeong 2023)
Number of sessions: 3 (with a 7-day interval between sessions)

Radial Shock Wave Therapy

Radial shock wave treatments will be performed without anesthesia. Prior to the procedure, the patient's skin surface at the treatment site will be covered with gel.
The patient will be positioned lying prone with a bolster placed under the ankles. The foot will be maintained in dorsiflexion. During the treatment, the entire Achilles tendon will be treated by slowly moving the applicator along the lateral, dorsal, and medial sides of the tendon. The following parameters will be applied:

Pressure: 3 bar
Number of impulses: 2,000
Frequency: 10 Hz
Number of sessions: 3 (with a 7-day interval between sessions)

Local vibration therapy will be administered first, followed by the application of radial shockwave therapy. The intervention will be performed by a qualified physiotherapist.
The entire therapeutic session, including local vibration treatment and radial shockwave therapy, will last approximately 15 minutes.

To ensure fidelity and adherence to the intended procedures, a standardized intervention protocol will be implemented. The physiotherapist involved in the study will undergo training prior to the intervention to ensure consistency in the delivery of treatment.

The intervention sessions will take place at the Department of Physical Medicine at the Jerzy Kukuczka Academy of Physical Education in Katowice.
Intervention code [1] 331144 0
Treatment: Other
Comparator / control treatment
In the control group, radial shock wave therapy (monotherapy) will be used.

Radial shock wave treatments will be performed without anesthesia. Prior to the procedure, the patient's skin surface at the treatment site will be covered with gel.

The patient will be positioned lying prone with a bolster placed under the ankles. The foot will be maintained in dorsiflexion. During the treatment, the entire Achilles tendon will be treated by slowly moving the applicator along the lateral, dorsal, and medial sides of the tendon. The following parameters will be applied:

Pressure: 3 bar
Number of impulses: 2,000
Frequency: 10 Hz
Number of sessions: 3 (with a 7-day interval between sessions)
Application time of the radial shockwave: approximately 8 minutes.

The intervention will be performed by a qualified physiotherapist.

The intervention sessions will take place at the Department of Physical Medicine at the Jerzy Kukuczka Academy of Physical Education in Katowice.

To ensure fidelity and adherence to the intended procedures, a standardized intervention protocol will be implemented. The physiotherapist involved in the study will undergo training prior to the intervention to ensure consistency in the delivery of treatment.
Control group
Active

Outcomes
Primary outcome [1] 341585 0
Biomechanical gait assessment of the patient on a treadmill
Timepoint [1] 341585 0
All measurements will be taken before the start of the therapy, as well as 1 (primary endpoint) and 6 weeks after its completion
Primary outcome [2] 341586 0
Assessment of Achilles pain threshold at rest
Timepoint [2] 341586 0
All measurements will be taken before the start of the therapy, as well as 1 (primary endpoint) and 6 weeks after its completion.
Secondary outcome [1] 448000 0
Assessment of resting pain intensity
Timepoint [1] 448000 0
All measurements will be taken before the start of the therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [2] 448001 0
Functional assessment of patients
Timepoint [2] 448001 0
All measurements will be conducted before the start of the therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [3] 448460 0
Assessment of pain intensity during physical activity
Timepoint [3] 448460 0
All measurements will be taken before the start of the therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [4] 448461 0
Assessment of nocturnal pain intensity
Timepoint [4] 448461 0
All measurements will be taken before the start of the therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [5] 448462 0
Functional assessment of patients
Timepoint [5] 448462 0
All measurements will be conducted before the start of the therapy, as well as 1 and 6 weeks after its completion.

Eligibility
Key inclusion criteria
Informed consent to participate in the study

Age between 18 and 45 years

Symptoms persisting for at least 3 months

Mid-portion Achilles tendinopathy (symptoms located 2 to 6 cm proximal to the tendon’s insertion on the calcaneus)

Tendon changes visible on ultrasound imaging (presence of focal hypoechoic areas, vascular abnormalities, or localized swelling)

Recreationally active patients (aerobic activity for 80 minutes at moderate intensity once or twice a week)
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insertional Achilles tendinopathy (when pathological changes involve the distal part of the tendon at its attachment to the posterior aspect of the calcaneal tuberosity)

Age under 18 years

Pregnancy

Thrombophlebitis

Atherosclerosis

Renal failure

Local infection in the lower limb

Cancer

Previous surgery on the Achilles tendon

Knee joint instability

Ankle joint instability

Leg length discrepancy

Dermatitis of the lower limb

Anticoagulant therapy

Physical therapy within the last 6 weeks

Corticosteroid injections within the last 6 weeks

Type I or insulin-treated Type II diabetes

Rheumatoid arthritis and other rheumatic diseases

Pacemaker

Cardiac arrhythmias

Heart failure

Patellar tendon enthesopathy

Bilateral Achilles tendinopathy

History of stroke (ischemic or hemorrhagic)

Acute post-traumatic condition

Hypersensitivity to shock wave therapy

Cemented prosthesis

Tumor

Vascular fragility

Osteoporosis

Epilepsy

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 will be concealed with sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a sealed opaque envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/07/2025
Actual
Date of last participant enrolment
Anticipated
9/10/2028
Actual
Date of last data collection
Anticipated
15/12/2028
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 27080 0
Poland
State/province [1] 27080 0

Funding & Sponsors
Funding source category [1] 319059 0
University
Name [1] 319059 0
Jerzy Kukuczka Academy of Physical Education in Katowice
Country [1] 319059 0
Poland
Primary sponsor type
University
Name
Jerzy Kukuczka Academy of Physical Education in Katowice
Address
Country
Poland
Secondary sponsor category [1] 321522 0
Commercial sector/Industry
Name [1] 321522 0
Orto-Sport Piotr Zagórski in Katowice
Address [1] 321522 0
Country [1] 321522 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317661 0
Uczelniana Komisja Bioetyczna ds. Badan Naukowych przy Akademii Wychowania Fizycznego im. Jerzego Kukuczki w Katowicach
Ethics committee address [1] 317661 0
Ethics committee country [1] 317661 0
Poland
Date submitted for ethics approval [1] 317661 0
08/01/2025
Approval date [1] 317661 0
06/02/2025
Ethics approval number [1] 317661 0
8 /II/2025

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

Contacts
Principal investigator
Name 141738 0
Ms Stania Magdalena
Address 141738 0
Jerzy Kukuczka Academy of Physical Education, Mikolowska 72A, 40-065 Katowice
Country 141738 0
Poland
Phone 141738 0
+48 322075129
Fax 141738 0
Email 141738 0
[email protected]
Contact person for public queries
Name 141739 0
Stania Magdalena
Address 141739 0
Jerzy Kukuczka Academy of Physical Education, Mikolowska 72A, 40-065 Katowice
Country 141739 0
Poland
Phone 141739 0
+48 322075129
Fax 141739 0
Email 141739 0
[email protected]
Contact person for scientific queries
Name 141740 0
Stania Magdalena
Address 141740 0
Jerzy Kukuczka Academy of Physical Education, Mikolowska 72A, 40-065 Katowice
Country 141740 0
Poland
Phone 141740 0
+48 322075129
Fax 141740 0
Email 141740 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be shared due to ethical considerations and data protection regulations. However, aggregated results and summary data will be made available upon reasonable request."



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Uchwala Komisji Bioetycznej8-sig.pdf


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.