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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tennis elbow

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

Other neurological disorders

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

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]

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]

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]

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]

Calcification assessed by changes in the CT image.

Timepoint [1]

At baseline and after the last intervention.

Secondary outcome [2]

Secondary outcome was strength of finger flexors in flexion of the wrist and in extension of the wrist measured with hand dynamometer.

Timepoint [2]

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]

Secondary outcome was measured grip of hand with hand dynamometer.

Timepoint [3]

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]

Secondary outcome was measured range of motion in flexion, extension, pronating and supinating of the wrist with goniometer.

Timepoint [4]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Silesia

Funding & Sponsors

Funding source category [1]

University

Name [1]

Medical University of Silesia, Katowice, Poland

Address [1]

Medykow 18 Street
40-752 Katowice, Poland
Poland

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not required

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Evaluation of the analgesic efficacy of HVPC in the treatment of enthesopathy of the lateral epicondyle of the humerus (tennis elbow).

Trial website

Trial related presentations / publications

Public notes

Only patients who gave their written consent to participate in the study were included in the study.
Whereas the reason why ethics approval is not required is that HVPC treatments are standard analgesic treatments used in treatment (physical therapy).

Contacts

Principal investigator

Name

Dr Pawel Dolibog

Address

Department of Medical Biophysics
Faculty of Medical Sciences in Katowice,
Medical University of Silesia, Katowice, Poland
Medyków 18 Street
40-752 Katowice

Country

Poland

Phone

+48322088424

Fax

[email protected]

Contact person for public queries

Name

Pawel Dolibog

Address

Department of Medical Biophysics
Faculty of Medical Sciences in Katowice,
Medical University of Silesia, Katowice, Poland
Medyków 18 Street
40-752 Katowice

Country

Poland

Phone

+48322088424

Fax

[email protected]

Contact person for scientific queries

Name

Pawel Dolibog

Address

Department of Medical Biophysics
Faculty of Medical Sciences in Katowice,
Medical University of Silesia, Katowice, Poland
Medyków 18 Street
40-752 Katowice

Country

Poland

Phone

+48322088424

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Analgesic and Functional Efficiency of High-Voltage Electrical Stimulation in Patients with Lateral Epicondylitis-A Report with a 180-Day Follow-Up.	2022	https://dx.doi.org/10.3390/jcm11092571

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically