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Trial registered on ANZCTR


Registration number
ACTRN12621001389897
Ethics application status
Not required
Date submitted
20/03/2021
Date registered
14/10/2021
Date last updated
14/10/2021
Date data sharing statement initially provided
14/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of high voltage monophasic pulsed current in tennis elbow treatment.
Scientific title
The effect of high voltage monophasic pulsed current therapy on the level of pain perception associated with enthesopathy of the lateral epicondyle of the humerus.
Secondary ID [1] 303032 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tennis elbow 320105 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318039 318039 0 0
Physiotherapy
Neurological 318040 318040 0 0
Other neurological disorders
Musculoskeletal 320477 320477 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the research project, it is planned to create 2 homogeneous comparative groups (60 patients). Therapy will take place in the Chair and Department of Medical Biophysics at the Faculty of Medical Sciences in Katowice of Medical University of Silesia in Katowice.
Patients will be assigned to particular groups.
HVMPC (high voltage monophasic pulsed current) group with diagnosis of tennis elbow: the study (n = 30) will be applied in the form of 5 days a week (Monday-Friday) for a period of 2 weeks (10 sessions), each session takes 50 minutes, using a high voltage monophasic pulsed current with parameters: monophasic pulses with duration of 200 ms and frequency of 100 Hz, current will be set between 18 - 25 mA. The electrodes will be placed on gauze pad saturated with physiological saline. The active electrode (48 cm2) will be placed on the lateral epicondyle of the diseased upper limb. The passive electrode (48 cm2) will be placed on the forearm of the affected upper limb. The results will be blinded and saved on a computer file. One neurologist will deliver each treatment in group and checked attendance.
Intervention code [1] 319323 0
Rehabilitation
Intervention code [2] 319324 0
Treatment: Other
Intervention code [3] 321810 0
Treatment: Devices
Comparator / control treatment
Norm group will be healthy volunteers: the control group will not be administered the same treatment programme as the HVMPC group. All volunteers in the norm group will be measured:
- hand grip strength of both upper limbs; strength of wrist flexors and extensors in the right and left limbs using a Saehan Corporation dynamometer;
- range of wrist flexion and extension in the right and left upper limbs; range of forearm supination and pronation in the right and left upper limbs using a goniometer.
Control group
Active

Outcomes
Primary outcome [1] 326032 0
The analgesic efficacy of high voltage monophasic pulsed current in the treatment of tennis elbow was measured by Visual Analogue Scale - VAS (0 - lack of pain and 10 - the strongest pain).
Timepoint [1] 326032 0
At baseline, after the last intervention, and in: week 2, week 4, week 6, week 12 and week 24 after the last intervention.
Primary outcome [2] 326033 0
The effectiveness of therapy of high voltage monophasic pulsed current in the treatment of tennis elbow was measured by Laitinen Pain Scale - LPS
The LPS is a composite of 4 indicators: pain intensity, frequency of pain occurrence, use of analgesics, and limitations of mobility. The total maximum score for four indicators is 16 points (4 points in each of the indicators), while the lower the LPS score , the better for the patient.
Timepoint [2] 326033 0
At baseline, after the last intervention, and in: week 2, week 4, week 6, week 12 and week 24 after the last intervention.
Secondary outcome [1] 389920 0
Calcification assessed by changes in the CT image.
Timepoint [1] 389920 0
At baseline and after the last intervention.
Secondary outcome [2] 398520 0
Secondary outcome was strength of finger flexors in flexion of the wrist and in extension of the wrist measured with hand dynamometer.
Timepoint [2] 398520 0
At baseline, after the last intervention, and in: week 2, week 4, week 6, week 12 and week 24 after the last intervention.
Secondary outcome [3] 401326 0
Secondary outcome was measured grip of hand with hand dynamometer.
Timepoint [3] 401326 0
At baseline, after the last intervention, and in: week 2, week 4, week 6, week 12 and week 24 after the last intervention.
Secondary outcome [4] 401327 0
Secondary outcome was measured range of motion in flexion, extension, pronating and supinating of the wrist with goniometer.
Timepoint [4] 401327 0
At baseline, after the last intervention, and in: week 2, week 4, week 6, week 12 and week 24 after the last intervention.

Eligibility
Key inclusion criteria
In HVMPC group:
diagnosed tennis elbow,
pain that has been present for at least 1 month,
pain on palpation of the lateral epicondyle
pain with resistance wrist extension
pain with resistance extension of the middle finger
current X-ray examination.

In Norm group:
does not suffer from tennis elbow
not pain that has been present for at least 1 month,
not pain on palpation of the lateral epicondyle
not pain with resistance wrist extension
not pain with resistance extension of the middle finger
current X-ray examination.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Shoulder diseases,
Diseases of the cervical and thoracic spine,
Degeneration of the elbow and hand joints,
Neurological disorders (carpal tunnel syndrome),
Pregnancy,
Local infection in the upper limb,
Cancer,
Disorders of the mobility of the elbow joint,
Dermatitis in the upper limb,
Anticoagulant therapy,
Physical therapy during the last 6 weeks,
Corticosteroid injections performed within the last 6 weeks,
Diabetes,
Implanted pacemaker,
Heart arythmia,
Cardiovascular failure,
Golfer's elbow in the same limb.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Efficacy
Statistical methods / analysis
The obtained results will be subjected to statistical analysis made with Microsoft Excel and the STATISTICA software (TIBCO Software Inc. (2017). Statistica (data analysis software system), version 13. http://statistica.io.).
The statistical analysis of the results will be performed using either parametric or nonparametric tests, depending on the distribution of variable (Shapiro-Wilk test).
The level of statistical significance will be p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
13/09/2019
Date of last data collection
Anticipated
Actual
1/12/2020
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 23296 0
Poland
State/province [1] 23296 0
Silesia

Funding & Sponsors
Funding source category [1] 307446 0
University
Name [1] 307446 0
Medical University of Silesia, Katowice, Poland
Country [1] 307446 0
Poland
Primary sponsor type
University
Name
Medical University of Silesia, Katowice, Poland
Address
Medykow 18 Street
40-752 Katowice, Poland
Poland
Country
Poland
Secondary sponsor category [1] 308120 0
None
Name [1] 308120 0
Address [1] 308120 0
Country [1] 308120 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 307524 0
Ethics committee address [1] 307524 0
Ethics committee country [1] 307524 0
Date submitted for ethics approval [1] 307524 0
Approval date [1] 307524 0
Ethics approval number [1] 307524 0

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

Contacts
Principal investigator
Name 107546 0
Dr Pawel Dolibog
Address 107546 0
Department of Medical Biophysics
Faculty of Medical Sciences in Katowice,
Medical University of Silesia, Katowice, Poland
Medyków 18 Street
40-752 Katowice
Country 107546 0
Poland
Phone 107546 0
+48322088424
Fax 107546 0
Email 107546 0
pawel.dolibog@sum.edu.pl
Contact person for public queries
Name 107547 0
Pawel Dolibog
Address 107547 0
Department of Medical Biophysics
Faculty of Medical Sciences in Katowice,
Medical University of Silesia, Katowice, Poland
Medyków 18 Street
40-752 Katowice
Country 107547 0
Poland
Phone 107547 0
+48322088424
Fax 107547 0
Email 107547 0
pawel.dolibog@sum.edu.pl
Contact person for scientific queries
Name 107548 0
Pawel Dolibog
Address 107548 0
Department of Medical Biophysics
Faculty of Medical Sciences in Katowice,
Medical University of Silesia, Katowice, Poland
Medyków 18 Street
40-752 Katowice
Country 107548 0
Poland
Phone 107548 0
+48322088424
Fax 107548 0
Email 107548 0
pawel.dolibog@sum.edu.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
EmbaseAnalgesic and Functional Efficiency of High-Voltage Electrical Stimulation in Patients with Lateral Epicondylitis-A Report with a 180-Day Follow-Up.2022https://dx.doi.org/10.3390/jcm11092571
N.B. These documents automatically identified may not have been verified by the study sponsor.