Trial Review

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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] 306153 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hamstring shortening 324852 0
injures 324854 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322289 322289 0 0
Physiotherapy
Musculoskeletal 323504 323504 0 0
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] 322557 0
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] 330049 0
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] 330049 0
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] 330050 0
'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] 330050 0
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] 404728 0
Nil
Timepoint [1] 404728 0
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?
No
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
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 24480 0
Spain
State/province [1] 24480 0
Avila

Funding & Sponsors
Funding source category [1] 310494 0
University
Name [1] 310494 0
Catholic University of Ávila
Country [1] 310494 0
Spain
Primary sponsor type
Individual
Name
Elena Sánchez Jiménez
Address
Catholic University of Ávila
C/Canteros S/N
05005 Ávila
Country
Spain
Secondary sponsor category [1] 311660 0
Individual
Name [1] 311660 0
Ana Martín Jiménez
Address [1] 311660 0
Catholic University of Ávila
C/Canteros S/N
05005 Ávila
Country [1] 311660 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310124 0
University Hospital of Mostoles
Ethics committee address [1] 310124 0
Ethics committee country [1] 310124 0
Spain
Date submitted for ethics approval [1] 310124 0
23/04/2021
Approval date [1] 310124 0
13/05/2021
Ethics approval number [1] 310124 0
CEIC 2021/018

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

Contacts
Principal investigator
Name 116558 0
Prof ELENA SANCHEZ JIMENEZ
Address 116558 0

Catholic University of Ávila
C/Canteros S/N
05005 Ávila
Country 116558 0
Spain
Phone 116558 0
+034920251020
Fax 116558 0
Email 116558 0
[email protected]
Contact person for public queries
Name 116559 0
ELENA SANCHEZ JIMENEZ
Address 116559 0
Catholic University of Ávila
C/Canteros S/N
05005 Ávila
Country 116559 0
Spain
Phone 116559 0
+034920251020
Fax 116559 0
Email 116559 0
[email protected]
Contact person for scientific queries
Name 116560 0
ELENA SANCHEZ JIMENEZ
Address 116560 0
Catholic University of Ávila
C/Canteros S/N
05005 Ávila
Country 116560 0
Spain
Phone 116560 0
+034920251020
Fax 116560 0
Email 116560 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Dependent variable: sex, age,sport category, years of training.
Independent variable:hip joint range (SLR) and popliteal angle (PA)
When will data be available (start and end dates)?
Start:01/06/2022
End: 15/06/2022
Available to whom?
Researchers who provide a methodologically sound proposal,
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14616Ethical approval    383375-(Uploaded-04-05-2022-01-00-35)-Study-related document.pdf
14618Informed consent form    383375-(Uploaded-04-05-2022-01-06-30)-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.