Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000629437
Ethics application status
Approved
Date submitted
20/05/2025
Date registered
16/06/2025
Date last updated
16/06/2025
Date data sharing statement initially provided
16/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Combined Shockwave and Vibration Therapy on Tennis Elbow
Scientific title
The Impact of Combined Radial Shockwave Therapy and Local Vibration on Motor Function in Patients with Lateral Epicondylitis
Secondary ID [1] 314485 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lateral Epicondylitis 337525 0
Condition category
Condition code
Musculoskeletal 333891 333891 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 333892 333892 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the experimental group, patients receiving combined therapy will undergo both local vibration treatment and radial shockwave therapy. Local vibration therapy will be administered first, followed by the application of radial shockwave therapy. The intervention will be performed by a qualified physiotherapist.

Local Vibration Therapy

Local vibration treatments will be performed using the Storz Medical Duolith SD1 device with the V25 vibration transmitter (Ø 25 mm). For patients with significant body hair, the skin area to be treated will be covered with gel prior to the procedure.
The patient will be seated with the arm abducted and the elbow flexed to approximately 60°. The forearm will be positioned in pronation and supported, along with the hand, on the therapy table. During the procedure, the supinator muscle, tendons, and muscle bellies of the wrist and finger extensor muscles will be dynamically treated. The following parameter values will be applied:
Vibration frequency: 30 Hz
Pressure: 3 bars
Number of vibrations: 2000 (Hyo Jeong 2023)
Number of sessions: 3 (with a 7-day interval between sessions)

Radial Shockwave Therapy

Radial shockwave treatments will be performed without anesthesia. Before the procedure, the skin surface to be treated will be covered with gel.
The patient will be seated with the arm abducted and the elbow flexed to approximately 60°. The forearm will be positioned in pronation and supported, along with the hand, on the therapy table. The shockwave pulses will be applied to the most painful point in the area of the lateral epicondyle. The following parameter values will be used:
Pressure: 2.5 bars
Number of pulses: 2000
Frequency: 8 Hz
Number of sessions: 3 (with a 7-day interval between sessions)

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] 331108 0
Treatment: Other
Comparator / control treatment
In the control group, radial shockwave therapy (monotherapy) will be used as the treatment method. The intervention will be performed by a qualified physiotherapist.
Radial shockwave treatments will be performed without anesthesia. Before the procedure, the skin surface to be treated will be covered with gel.
The patient will be seated with the arm abducted and the elbow flexed to approximately 60°. The forearm will be positioned in pronation and supported, along with the hand, on the therapy table. The shockwave pulses will be applied to the most painful point in the area of the lateral epicondyle. The following parameter values will be used:
Pressure: 2.5 bars
Number of pulses: 2000
Frequency: 8 Hz
Number of sessions: 3 (with a 7-day interval between sessions)

The therapeutic session, including radial shockwave therapy, will last approximately 7 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.
Control group
Active

Outcomes
Primary outcome [1] 341532 0
Isokinetic assessment of the strength of wrist flexor muscles
Timepoint [1] 341532 0
Before the start of therapy, as well as 1 (primary endpoint) and 6 weeks after its completion.
Primary outcome [2] 341694 0
Isokinetic assessment of the strength of wrist extensor muscles
Timepoint [2] 341694 0
Before the start of therapy, as well as 1 (primary endpoint) and 6 weeks after its completion.
Secondary outcome [1] 447852 0
Pain threshold assessment
Timepoint [1] 447852 0
Before the start of therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [2] 447853 0
Intensity of resting pain
Timepoint [2] 447853 0
Before the start of therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [3] 447854 0
Assessment of disability in the affected upper limb
Timepoint [3] 447854 0
Before the start of therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [4] 448385 0
Intensity of pain during physical activity
Timepoint [4] 448385 0
Before the start of therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [5] 448386 0
Intensity of night pain
Timepoint [5] 448386 0
Before the start of therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [6] 448387 0
Assessment of disability in the affected upper limb
Timepoint [6] 448387 0
Before the start of therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [7] 448388 0
Measurement of the strength of wrist extensor muscles
Timepoint [7] 448388 0
Before the start of therapy, as well as 1 and 6 weeks after its completion.
Secondary outcome [8] 448389 0
Measurement of the strength of wrist flexors muscles
Timepoint [8] 448389 0
Before the start of 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

Lateral epicondyle pain of the humerus persisting for at least 3 months

Pain during palpation of the lateral epicondyle of the humerus

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

Positive Thomson test (pain during resisted extension of the radiocarpal joint with the elbow extended, forearm in pronation, wrist slightly extended, and fingers clenched in a fist)

Positive Mill’s test (pain during resisted supination of the forearm with the elbow slightly flexed, forearm in pronation, wrist slightly extended, and fingers clenched in a fist)

Pain during resisted extension of the middle finger
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18

Thrombophlebitis

Atherosclerosis

Renal failure

Local infection in the upper limb

Cancer

Implanted pacemaker

Cardiac arrhythmia

Cardiovascular failure

Anticoagulant therapy

Physiotherapy conducted within the last 6 weeks

Corticosteroid injections administered within the last 6 weeks

Diabetes

Rheumatoid arthritis and other rheumatic diseases

Cancer

Pregnancy

Post-traumatic changes in the shoulder joint

Cervical and thoracic spine disorders

Degenerative changes in the elbow and hand joints

Neurological disorders (carpal tunnel syndrome, cubital tunnel syndrome, radial nerve entrapment)

Local infections in the upper limb

Dermatitis in the upper limb

Elbow joint instability

Bilateral tennis elbow

Golfer’s elbow

Acute post-traumatic condition

Hypersensitivity to shockwave 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)
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
16/06/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2028
Actual
Date of last data collection
Anticipated
6/11/2028
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 27076 0
Poland
State/province [1] 27076 0

Funding & Sponsors
Funding source category [1] 319027 0
University
Name [1] 319027 0
Jerzy Kukuczka Academy of Physical Education in Katowice
Country [1] 319027 0
Poland
Primary sponsor type
University
Name
Jerzy Kukuczka Academy of Physical Education in Katowice
Address
Country
Poland
Secondary sponsor category [1] 321491 0
Commercial sector/Industry
Name [1] 321491 0
Orto-Sport Piotr Zagórski in Katowice
Address [1] 321491 0
Country [1] 321491 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317635 0
Uczelniana Komisja Bioetyczna ds. Badan Naukowych przy Akademii Wychowania Fizycznego im. Jerzego Kukuczki w Katowicach
Ethics committee address [1] 317635 0
Ethics committee country [1] 317635 0
Poland
Date submitted for ethics approval [1] 317635 0
08/01/2025
Approval date [1] 317635 0
06/02/2025
Ethics approval number [1] 317635 0
8 /II/2025

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

Contacts
Principal investigator
Name 141642 0
Mrs Stania Magdalena
Address 141642 0
Academy of Physical Education, Mikolowska 72A, 40-065 Katowice
Country 141642 0
Poland
Phone 141642 0
+48 322075129
Fax 141642 0
Email 141642 0
[email protected]
Contact person for public queries
Name 141643 0
Stania Magdalena
Address 141643 0
Academy of Physical Education, Mikolowska 72A, 40-065 Katowice
Country 141643 0
Poland
Phone 141643 0
+48 322075129
Fax 141643 0
Email 141643 0
[email protected]
Contact person for scientific queries
Name 141644 0
Stania Magdalena
Address 141644 0
Academy of Physical Education, Mikolowska 72A, 40-065 Katowice
Country 141644 0
Poland
Phone 141644 0
+48 322075129
Fax 141644 0
Email 141644 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.