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Trial registered on ANZCTR

Registration number

ACTRN12622000815763

Ethics application status

Approved

Date submitted

10/01/2022

Date registered

9/06/2022

Date last updated

9/06/2022

Date data sharing statement initially provided

9/06/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Effectiveness of electrical elongation versus stretches with neuromuscular facilitation in the lower member in athletes: A pilot study

Scientific title

Effectiveness of electrical elongation versus stretched with neuromuscular facilitation in the lower member in semi-professional athletes: A pilot study

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

hamstring shortening

injures

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Electrical muscle elongation will be performed using the hold-relaxation technique as indicated in the literature . Two 5x5 cm and one 9x5 cm adhesive electrodes will be used. According to Basas A., the 9x5cm electrodes are placed in the proximal third of the hamstrings, one 5x5cm in the mid-distal third of the semimembranosus and semitendinosus and the other 5x5cm in the distal third of the biceps femoris.
The hamstring muscles will be stretched until a feeling of tension appears on the subject. At this point, the intensity of the current will be increased until the muscle contraction is produced, while the intervener slows down the movement to generate an isometric contraction. A symmetric biphasic low frequency current (of frequency 50 Hz) will be applied at an amplitude of 0.2-0.3 seconds for 30 seconds. The muscle will then be stretched again to a new barrier. A total of 3 repetitions will be performed.The approximate total duration of each intervention session, e.g. 1,5 minutes.
Intervention will be performed 2 sessions per week, with a separation of 3 days during 2 consecutive weeks, with a total of 4 sessions in the lower limb with more shortening.
The intervention will be carried out by a specialized physiotherapist in the physiotherapy center of the sports club.To monitor adherence to the intervention used session attendance checklists.

Intervention code [1]

Treatment: Other

Comparator / control treatment

In the other group stretching will be performed using the hold-relaxation technique. The limb will be placed in 90º hip flexion, knee in extension and resting on the shoulder of the intervener. The subject will be instructed to push the leg toward the investigator's shoulder for 10 seconds while the intervener resists the movement causing an isometric contraction. After 10 seconds, the subject will be instructed to relax to perform a passive stretch until the next barrier is reached. This new position will be held for 30 seconds and a total of 3 repetitions will be performed .The approximate total duration of each intervention session, e.g. 1,5 minutes.
Intervention will be performed 2 sesions per week, with a separation of 3 days during 2 consecutive weeks, with a total of 4 sessions in the lower limb with more shortening.
The intervention will be carried out by a specialized physiotherapist in the physiotherapy center of the sports club.To monitor adherence to the intervention used session attendance checklists.

Control group

Active

Outcomes

Primary outcome [1]

Hamstring extensibility will be assessed by measuring the angle of hip flexion at which pain is elicited during a straight leg raise (SLR) test. This measurement will be made in both extremities, registering the lowest value of the two extremities',

Timepoint [1]

During 4 sessions immediately before and after each intervention session and a last measurement a week after the final session (primary endpoint)

Primary outcome [2]

'Hamstring flexibility will be assessed by measuring the knee extension angle at which tension is elicited by performing the popliteal angle test; this will be done in both extremities, registering the lowest value of the two extremities

Timepoint [2]

During 4 sessions immediately before and after each intervention session and a last measurement a week after the final session (primary endpoint)

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

Semi-professional athletes with a positive SLR test who previously signed the informed consent.

Minimum age

21 Years

Maximum age

35 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Those who presented lumbar or musculoskeletal pain in the lower limbs, recent spinal or abdominal surgery, subjects who performed a stretching program of the hamstring muscles in an organized manner or who presented musculoskeletal injuries in the posterior region of the leg were excluded

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)

The assignment to one intervention group to another will be made through the selection of sealed envelopes.

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 receiving the treatment/s

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

We will proceed to compare the results of straight leg raising test (SLR ) and the popliteal angle test (PA) between experimental group A (GEA) and experimental group B(GEB) their temporal variation and the differences between the pre and post measurements of each session. Given the low number of N (pilot study) non-parametric tests will be used: Wilcoxon test and Friedman test for intragroup comparisons and Mann-Whitney test for GEA and GEB intergroup comparisons. Significance is considered when p <0.05 and high significance when p <0.01. The effect size estimate (on the R2 scale) is added as an indicator of the magnitude of the changes. An effect greater than 6% (R2> 0.60) is a sign of a moderate effect to consider

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

15/06/2022

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Avila

Funding & Sponsors

Funding source category [1]

University

Name [1]

Catholic University of Ávila

Country [1]

Spain

Primary sponsor type

Individual

Name

Elena Sánchez Jiménez

Country

Spain

Secondary sponsor category [1]

Individual

Name [1]

Ana Martín Jiménez

Country [1]

Spain

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University Hospital of Mostoles

Ethics committee address [1]

Río Júcar, s/n, 28936Móstoles (Madrid)

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

23/04/2021

Approval date [1]

13/05/2021

Ethics approval number [1]

CEIC 2021/018

Summary

Brief summary

The decrease in the extensibility of the hamstrings is very common in the sports field and can affect sports performance  since it has been related to muscle injuries, patellar tendinopathy, femoro-patellar pain and lumbar pain due to changes in lumbo-pelvic rhythm .
The assessment of extensibility is performed through the straight leg raising (SLR) test and the popliteal angle (PA) test The concurrent validity of these tests was examined, concluding that they are the most reliable tests, since they require a single joint for their execution, they do not imply a global movement as it occurs in other diagnostic tests .
Muscle stretching is applied to both prevention and treatment of muscle injuries. There are various stretching techniques to increase muscle extensibility. Stretching is usually performed during warm-up, that is, before performing sports activity to increase joint range, reduce musculoskeletal rigidity and improve sports performance   Today there are not enough studies to determine which technique is the most effective 
The use of electrical current to produce muscle contraction and subsequent stretching offers a series of additional advantages to traditional muscle stretching .
It generates an increase in the extensibility of the musculature by increasing the temperature and reducing the pain transmission, thus increasing the sliding of the collagen matrix using transcutaneous electrical stimulation .
¥	It causes a stronger contraction than if done voluntarily, as there is an increase in the recruitment of motor units of between 20 and 60%, it generates tension in the entire connective tissue of the muscles to which the technique is applied .
¥	Prevents relative vasoconstriction caused by conventional stretching techniques.
Therefore, the hypothesis of this study is that electrical elongation acts by improving the extensibility of the hamstrings, more than  stretches with neuromuscular facilitation.

Trial website

Public notes

Contacts

Principal investigator

Name

Prof ELENA SANCHEZ JIMENEZ

Address

Catholic University of Ávila C/Canteros S/N 05005 Ávila

Country

Spain

Phone

+034920251020

Fax

elena.sanchez@ucavila.es

Contact person for public queries

Name

ELENA SANCHEZ JIMENEZ

Address

Catholic University of Ávila C/Canteros S/N 05005 Ávila

Country

Spain

Phone

+034920251020

Fax

elena.sanchez@ucavila.es

Contact person for scientific queries

Name

ELENA SANCHEZ JIMENEZ

Address

Catholic University of Ávila C/Canteros S/N 05005 Ávila

Country

Spain

Phone

+034920251020

Fax

elena.sanchez@ucavila.es

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers who provide a methodologically sound proposal,

Conditions for requesting access:
• -

What individual participant data might be shared?

• Dependent variable: sex, age,sport category, years of training.
Independent variable:hip joint range (SLR) and popliteal angle (PA)

What types of analyses could be done with individual participant data?

• Only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?

From:
Start:01/06/2022
End: 15/06/2022

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• elena.sanchez@ucavila.es

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14616	Ethical approval					Study-related document.pdf
14618	Informed consent form					Study-related document.docx

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.

Trial Review

Documents added manually

Documents added automatically