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Trial registered on ANZCTR


Registration number
ACTRN12624000073505
Ethics application status
Approved
Date submitted
27/07/2023
Date registered
29/01/2024
Date last updated
29/01/2024
Date data sharing statement initially provided
29/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined Physiotherapy in the Approach to Work-Related Epicondylalgia
Scientific title
Combined Treatment of Different Electrotherapy Techniques Plus Exercise in the Management of Work-Related Epicondylalgias,for workers aged 18-65.
Secondary ID [1] 310206 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Work-Related Epicondylalgias 330882 0
tendinopathies
 331563 0
Condition category
Condition code
Injuries and Accidents 327669 327669 0 0
Other injuries and accidents
Musculoskeletal 327670 327670 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 328299 328299 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will compare two highly popular electrotherapy treatments in physiotherapy: electrolysis and peripheral magnetic stimulation. The duration of the intervention will be 6 weeks. For this purpose, three groups will be established:

Control Group: Gold standard treatment. Exercise plus diathermy.
Exercise Protocol:

-Isometric exercises: On alternate days, 4-5 repetitions of 30 seconds with 1-2 minutes of rest between repetitions, progressively increasing the time up to 45 seconds, at 70% of their calculated maximum voluntary contraction using a dynamometer.
-Eccentric exercises: 3 sets of 10 repetitions on alternate days, gradually increasing the load (2.5-5%), aiming for slight discomfort not exceeding 4-5/10 on the pain visual analog scale (EVA). Starting position will be wrist extension, finishing in wrist palmar flexion.
-Shoulder muscle strengthening: 3 sets of 15 repetitions, 2-3 days per week, depending on the worker's capacity (sedentary or active individual). This exercise targets the rotator cuff muscles. Patients will work on external and internal rotation, followed by shoulder flexion, shoulder abduction, and shoulder extension exercises with the same parameters (3 sets of 15 repetitions).
-Scapula and neck motor control: 3 basic exercises for each area, performing 3 sets of 10 repetitions with a focus on proper execution rather than load. Voluntary contraction of rhomboids, inferior trapezius, and serratus for shoulder stability, and deep flexors and extensors for the neck. They will perform a 10-second contraction with 25% of strength intensity during each 10-second contraction.
-Forearm and shoulder muscle stretches: Hold each stretch for 10 seconds and repeat 3 times daily during the treatment period.
Diathermy: 60 watts for 10 minutes. Static application with a variation of 250 EP, aiming for a comfortable warm sensation. Applied daily.

Intervention Group 1:
One session per week (on a day without programmed exercises or after completing exercises). Percutaneous ecoguided electrolysis on the injured tendon: 4-6 sessions maximum, applying one session per week. It involves 350 microseconds of galvanic current for 1 minute and 30 seconds, and 6-7 minutes of microcurrents (150Hz, intensity subthreshold less than 1mA) using the EPTE2 device.

- Exercise protocol.

-Diathermy: 60 watts for 10 minutes. Static application with a variation of 250 EP, aiming for a comfortable warm sensation. Applied daily.

Intervention Group 2:
They will receive the same treatment as intervention group 1 plus Radial nerve neuromodulation using peripheral electromagnetic stimulation (Magrex) at 80 Hz, sensory threshold, for 15 minutes daily until the end of the intervention. The application will be located over the shoulder 4 fingers above the epicondyle.

The treatments will be conducted in the physiotherapy facility of the work accident insurance company. The various treatments will be administered by the physiotherapists at the center, who have undergone prior training in different techniques and are supervised by a physiotherapist with over 10 years of experience in this type of treatment. All participants must complete more than 80% of the sessions, and attendance will be controlled with a checklist.
Intervention code [1] 326595 0
Treatment: Devices
Intervention code [2] 327068 0
Rehabilitation
Comparator / control treatment
"This is the protocol used at the rehabilitation center where the intervention will take place (worker's mutual insurance)

Control Group:

Diathermy: 60 watts for 10 minutes.Static application, variation 250 EP, patient should feel a comfortable warm sensation. Daily application.
Exercise Protocol (it will last 6 weeks):

-Isometric exercises: On alternate days, 4-5 repetitions of 30 seconds with 1-2 minutes of rest between repetitions, progressively increasing the time up to 45 seconds, at 70% of their calculated maximum voluntary contraction using a dynamometer.
-Eccentric exercises: 3 sets of 10 repetitions on alternate days, gradually increasing the load (2.5-5%), aiming for slight discomfort not exceeding 4-5/10 on the pain visual analog scale (EVA). Starting position will be wrist extension, finishing in wrist palmar flexion.
-Shoulder muscle strengthening: 3 sets of 15 repetitions, 2-3 days per week, depending on the worker's capacity (sedentary or active individual). This exercise targets the rotator cuff muscles. Patients will work on external and internal rotation, followed by shoulder flexion, shoulder abduction, and shoulder extension exercises with the same parameters (3 sets of 15 repetitions).
-Scapula and neck motor control: 3 basic exercises for each area, performing 3 sets of 10 repetitions with a focus on proper execution rather than load. Voluntary contraction of rhomboids, inferior trapezius, and serratus for shoulder stability, and deep flexors and extensors for the neck. They will perform a 10-second contraction with 25% of strength intensity during each 10-second contraction.
-Forearm and shoulder muscle stretches: Hold each stretch for 10 seconds and repeat 3 times daily during the treatment period..
All sessions will be supervised by an expert physical therapist.
all participants must complete more than the 80% of the sessions and the assistance will be controlled with a checklist.
Control group
Active

Outcomes
Primary outcome [1] 335489 0
Dynamometry: Measurement of isometric strength in the flexor muscles of the wrist, using the ActiveForce 2 dynamometer (Activbody, San Diego, CA).
Timepoint [1] 335489 0
before the first day of treatment
after the last day of treatment (normally 6 weeks, primary tmepoint))
6 months after the end of the treatment
Primary outcome [2] 335490 0
Goniometry: Measurement of elbow flexion, extension, and pronosupination using an universal goniometer. all measures will be assessed as a composite primary outcome
Timepoint [2] 335490 0
before the first day of treatment
after the last day of treatment (normally 6 weeks, primary timepoint)
6 months after the end of the treatment
Primary outcome [3] 335491 0
Algometry: to calculate the pressure pain threshold measurement of the common extensor carpi radialis, extensor carpi radialis brevis, and extensor carpi radialis longus muscles in both elbows, using the algometer (Wagner instruments, Greenwich, USA). all measures will be assessed as a composite primary outcome
Timepoint [3] 335491 0
before the first day of treatment
after the last day of treatment (normally 6 weeks, primary outcome)
6 months after the end of the treatment
Secondary outcome [1] 424796 0
VAS Scale: Numeric ruler from 0 to 100.(primary outcome) to assess pain.
Timepoint [1] 424796 0
before the first day of treatment
after the last day of treatment (normally 6 weeks,primary timepoint)
6 months after the end of the treatment
Secondary outcome [2] 424797 0
Days of work absenteeism: number of days the patients would not be able to work due to the pathology. The days of sick leave will be counted from the time the doctor grants you sick leave, until you are discharged from work and are fit to work. An excel will be kept with the data provided by the doctor from the mutual insurance company.
Timepoint [2] 424797 0
the day they go back to work.
Secondary outcome [3] 424798 0
"Ultrasound imaging:to assess the thickness of the common wrist extensor tendon and the presence of hypervascularization. It will be performed using a Mindray M8 ultrasound system.:both measures will be assessed as a composite secondary outcome
Timepoint [3] 424798 0
before the first day of treatment
after the last day of treatment (normally 6 weeks)
6 months after the end of the treatment
Secondary outcome [4] 427259 0
Dynamometry: Measurement of isometric strength in the extensor muscles of the wrist, using the ActiveForce 2 dynamometer (Activbody, San Diego, CA).
Timepoint [4] 427259 0
before the first day of treatment
after the last day of treatment (normally 6 weeks,primary timepoint)
6 months after the end of the treatment
Secondary outcome [5] 427260 0
Dynamometry: Measurement of isometric strength ratio between flexors and extensor muscles of the wrist, using the ActiveForce 2 dynamometer (Activbody, San Diego, CA).
Timepoint [5] 427260 0
before the first day of treatment
after the last day of treatment (normally 6 weeks,primary timepoint)
6 months after the end of the treatment

Eligibility
Key inclusion criteria
Workers covered by Umivale (Worker's Mutual Insurance Company) with the epicondylitis therapy plan (ICD-10 code M77.1):

Confirmed by magnetic resonance imaging to have medial epicondylalgia.
Currently on sick leave due to medial epicondylalgia.
Who sign the informed consent to participate in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to participate or attend the treatment program.
Workers diagnosed with partial or complete tendon rupture.
Fractures or associated bone edema.

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 randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative variables will be expressed as absolute number and percentage, and quantitative variables as mean ± standard deviation if they follow a normal distribution, or as median and interquartile range (IQR) if not. To assess the normality of data distributions, the Kolmogorov-Smirnov test or Shapiro-Wilk test (for samples smaller than 50) will be used. For the comparison of qualitative variables, the chi square or the Fisher's exact test will be employed when necessary. For the comparison of quantitative variables, the Student's t-test will be used if it follows a normal distribution, or the Mann-Whitney U test otherwise. P-values less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/02/2024
Actual
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
4/11/2024
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 25667 0
Spain
State/province [1] 25667 0
Comunidad Valenciana

Funding & Sponsors
Funding source category [1] 314372 0
Hospital
Name [1] 314372 0
mutua umivale activa valencia
Country [1] 314372 0
Spain
Primary sponsor type
University
Name
Universidad Europea de Madrid
Address
c/ Tajo s/n 28670 Villaviciosa de Odón, Madrid
Country
Spain
Secondary sponsor category [1] 316322 0
None
Name [1] 316322 0
Address [1] 316322 0
Country [1] 316322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313465 0
comité de ética del ilustre colegio de fisioterapeutas de la comunidad valenciana
Ethics committee address [1] 313465 0
C/ de Sant Vicent Màrtir, 61, 2º, 2ª, 46002 Valencia
Ethics committee country [1] 313465 0
Spain
Date submitted for ethics approval [1] 313465 0
05/06/2023
Approval date [1] 313465 0
21/07/2023
Ethics approval number [1] 313465 0
CEICOFCV0002

Summary
Brief summary
The objective of this study is to verify the efficacy of a treatment based on the combination of evidence-based physiotherapy techniques in the management of tendinopathies.

A sample of 72 subjects diagnosed with medial epicondylalgia and on work leave will be divided into 3 groups. All groups will receive a common treatment, which will be the gold standard for tendinopathies: Isometric exercises + eccentric elbow exercises, with the addition of stretches, shoulder strength exercises, and motor control exercises based on the latest article by Stasinopoulos in 2022. To this treatment, the following will be added:

Group 1: + Diathermy
Group 2: + Diathermy + Percutaneous Electrolisis + Microcurrents
Group 3: + Diathermy + Percutaneous Electrolisis + Microcurrents + Radial Nerve Stimulation with Peripheral Magnetic Stimulation.

Primary outcome variables: Range of Motion (ROM), Visual Analog Scale (VAS) pain rating, dynamometry, algometry.
Secondary outcome variables: Days of work absenteeism, ultrasound imaging.

The participants will be treated until medical discharge and return to work, and a 6-month follow-up will be conducted to monitor possible relapses.

The main objective is to determine if the combination of treatments outperforms the therapeutic exercise gold standard in medial epicondylalgia.

Research Hypothesis:
Null Hypothesis: The combined physiotherapy treatment is not superior to therapeutic exercise in medial epicondylalgia.
Alternative Hypothesis: The use of different physiotherapy techniques along with therapeutic exercise shortens the recovery period in medial epicondylalgia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128258 0
Mr VICENT PONTES FORNER
Address 128258 0
MUTUA UMIVALE ACTIVA. Av. Reial Monestir Santa Maria de Poblet, 20, 46930 Quart de Poblet, València
Country 128258 0
Spain
Phone 128258 0
+34 665355394
Fax 128258 0
Email 128258 0
vpontes@umivaleactiva.es
Contact person for public queries
Name 128259 0
Dr ALBERTO SANCHEZ SIERRA
Address 128259 0
Universidad Europea de Madrid.C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid
Country 128259 0
Spain
Phone 128259 0
+34 608801238
Fax 128259 0
Email 128259 0
alberto.sanchez@universidadeuropea.es
Contact person for scientific queries
Name 128260 0
Dr ALBERTO SANCHEZ SIERRA
Address 128260 0
Universidad Europea de Madrid. C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid
Country 128260 0
Spain
Phone 128260 0
+34 608801238
Fax 128260 0
Email 128260 0
alberto.sanchez@universidadeuropea.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial,
When will data be available (start and end dates)?
Immediately following publication, no end date;
Available to whom?
anyone who wishes to access it,
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator vpontes@umivaleactiva.es


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19814Study protocol  alberto.sanchez@universidadeuropea.es
19815Informed consent form  alberto.sanchez@universidadeuropea.es 386300-(Uploaded-27-07-2023-20-25-51)-Study-related document.docx
19816Ethical approval  alberto.sanchez@universidadeuropea.es 386300-(Uploaded-27-07-2023-20-26-56)-Study-related document.pdf
20490Other  alberto.sanchez@universidadeuropea.es EXERCISE PROTOCOL 386300-(Uploaded-27-09-2023-07-05-05)-Study-related document.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.