Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000119190
Ethics application status
Approved
Date submitted
16/01/2019
Date registered
25/01/2019
Date last updated
25/01/2019
Date data sharing statement initially provided
25/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate and short-term effect of magnetic tape on strength and mobility.
Scientific title
Immediate and short-term effect of magnetic tape on the strength of hip abduction and the joint degrees of hip rotations in adult healthy volunteers
Secondary ID [1] 297106 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle dysfunction 311116 0
joint mobility limitation 311198 0
Condition category
Condition code
Musculoskeletal 309750 309750 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 309751 309751 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is performed by a physiotherapist.
The people will be divided into two groups randomly. One experimental group and one control group.
Each test consists of recording the maximum strength of the hip abduction in the first isometry of one lower limb and after the other in the supine decubitus position. Subsequently, the patient is placed in a sitting position and performs an internal and external maximum rotation of each hip actively. The rotations are then evaluated passively. The tape is then placed without adhering it between the anterior superior iliac crests to immediately afterwards measure the maximum force and the joint range in rotation. After ten minutes the tape is removed from the body and the strength and joint range of the rotations are measured again.
Each subject of the both groups will be given 3 repetitions of each test and the average value will be obtained. The duration of each test will be 3 seconds.
The time used in each session to perform the tests is 30 minutes.
At 24 hours without the tape, the maximum force and the rotation of the hip will be tested again.
Force and joint tests are standardized by other publications.
The experimental group will be the application of magnetic fields less than 50 Hz for 10 minutes between the anterior superior iliac spines using a magnetic tape without adhering the tape as it is an adhesive tape but we want not to intervene the possible tension produced by the adhesion of the tape in the body.
The control group will be the one that apply a tape without magnetic properties. Both tapes are equal to sight and touch.
The tape remains in place as the force test is performed in supine so no need for restraint and to assess the hip rotation in sitting position is held with the waist of the pants.
With the application of low intensity magnetic fields we intend to normalize the electrical signal that reaches the pelvic musculature helping to normalize the tone of the periarticular muscles, equalizing the force produced by both limbs and equaling the degrees of rotation of both hips. force and joint tests are standardized by other publications.
The maximum force, time to perform the maximum force and average force produced when performing abduction of lower limbs using the Lafayette dynamometer and a goniometer to assess the degrees of mobility of the hip joint bilaterally will be assessed.
One of the tapes will be numbered with the number one and the other tape with the number two. The decision of which tape will take each number will be made at the moment of beginning the study using the same random program to group the subjects. Said information will only be known to the principal investigator and this will tell the physiotherapist what number of the tape to use in each subject as indicated by the random designation program.
The subject will not know what kind of tape is what they have.
Intervention code [1] 313373 0
Treatment: Devices
Comparator / control treatment
Each test consists of recording the maximum strength of the hip abduction in the first isometry of one lower limb and after the other in the supine decubitus position. Subsequently, the patient is placed in a sitting position and performs an internal and external maximum rotation of each hip actively. The rotations are then evaluated passively. The tape is then placed without adhering it between the anterior superior iliac crests to immediately afterwards measure the maximum force and the joint range in rotation. After ten minutes the tape is removed from the body and the strength and joint range of the rotations are measured again.
At 24 hours without the tape, the maximum force and the rotation of the hip will be tested again.
Each subject of the both groups will be given 3 repetitions of each test and the average value will be obtained. The duration of each test will be 3 seconds.
The time used in each session to perform the tests is 30 minutes.
The tape will be placed between the anterior superior iliac spines without adhering the tape as it is an adhesive tape but we want not to intervene the possible tension produced by the adhesion of the tape in the body. Both tapes are equal to sight and touch.
The tape remains in place as the force test is performed in supine so no need for restraint and to assess the hip rotation in sitting position is held with the waist of the pants.
Each subject of the control group will be given 3 repetitions of each test and the average value will be obtained. The duration of each test will be 3 seconds.
The control group will be the one applied to the tape without producing magnetic fields for 10 minutes between the anterior superior iliac spines.
Strength and joint tests standardized by other publications are used to measure strength by performing abduction of hip in supine decubitus and hip rotation in sitting.
The maximum force, time to perform the maximum force and average force produced when performing abduction of lower limbs using the Lafayette dynamometer and a goniometer to assess the degrees of mobility of the hip joint bilaterally will be assessed.
Control group
Active

Outcomes
Primary outcome [1] 318710 0
Maximum force of hip abduction in supine decubitus using The Lafayette Manual Muscle Testing (MMT) System.
Timepoint [1] 318710 0
Force, 2 days
Primary outcome [2] 318711 0
Average force of hip abduction movement in supine decubitus using The Lafayette Manual Muscle Testing (MMT) System.
Timepoint [2] 318711 0
Average force, 2 days
Secondary outcome [1] 365784 0
The range of mobility in external rotation of the hip actively in sitting position using a standardized goniometer.
Timepoint [1] 365784 0
2 days
Secondary outcome [2] 366019 0
The range of mobility in internal rotation of the hip actively in sitting position using a standardized goniometer.
Timepoint [2] 366019 0
Internal rotation of the hip actively, two days
Secondary outcome [3] 366020 0
The range of mobility in external rotation of the hip passively in sitting position using a standardized goniometer.
Timepoint [3] 366020 0
external rotation of the hip passively, two days.
Secondary outcome [4] 366021 0
The range of mobility in internal rotation of the hip passively in sitting position using a standardized goniometer.
Timepoint [4] 366021 0
internal rotation of the hip passively, two days

Eligibility
Key inclusion criteria
No surgical interventions with prostheses in the lower limbs or rachis.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have a pacemaker.
Be pregnant.
Any contraindication to the application of magnetic fields.

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)
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 administering 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
The subjects of the study are people without specific pathology and also healthy recruited from the degree and postgraduate of the University of Valencia. It is intended to create two groups of at least 20 subjects each. A series of repeated-measures ANOVAs measures will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/02/2019
Actual
Date of last participant enrolment
Anticipated
15/03/2019
Actual
Date of last data collection
Anticipated
22/03/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 21207 0
Spain
State/province [1] 21207 0
Valencia

Funding & Sponsors
Funding source category [1] 301671 0
University
Name [1] 301671 0
University of Valencia, Spain
Country [1] 301671 0
Spain
Primary sponsor type
Individual
Name
Francisco Selva Sarzo
Address
Departament de Fisioteràpia
Facultat de Fisioteràpia
Universitat de València
C/ Gascó Oliag, 3
46010 Valencia
Country
Spain
Secondary sponsor category [1] 301388 0
None
Name [1] 301388 0
None
Address [1] 301388 0
None
Country [1] 301388 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302390 0
Comité Ético de Investigación en Humanos de la Universidad de Valencia
Ethics committee address [1] 302390 0
Avenida Blasco Ibañez 13 46010 Valencia España
Ethics committee country [1] 302390 0
Spain
Date submitted for ethics approval [1] 302390 0
07/01/2019
Approval date [1] 302390 0
10/01/2019
Ethics approval number [1] 302390 0
H1547569414958

Summary
Brief summary
The purpose of this study is to increase the maximum and average strength of the hip abduction in supine decubitus and the improvement of joint movement (ROM) of hip rotation in sitting.
The hypotheses of the study are:
- When a low intensity magnetic field is applied between the anterior superior iliac spines, an increase in force is produced when hip abduction is performed and an increase in ROM of hip rotation is produced.
- Immediately after the application of the magnetic field there is a significant increase in the average force performed during the 3-second test when hip abduction is performed and the range of motion of the hip rotations is improved.
- After 10 minutes of application, the significant increase in the average force during the 3-second test is maintained when performing the hip abduction and the range of movement of the hip rotations.
- After 24 hours from the treatment of magnetic fields for 10 minutes, the significant increase in force and range of motion of the hip rotations is maintained.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90070 0
Dr Francisco Selva Sarzo
Address 90070 0
Departament de Fisioteràpia
Facultat de Fisioteràpia
Universitat de València
C/ Gascó Oliag, 3
46010 Valencia
Country 90070 0
Spain
Phone 90070 0
+34 96 386 43 95
Fax 90070 0
Email 90070 0
[email protected]
Contact person for public queries
Name 90071 0
Dr Francisco Selva Sarzo
Address 90071 0
Departament de Fisioteràpia
Facultat de Fisioteràpia
Universitat de València
C/ Gascó Oliag, 3
46010 Valencia
Country 90071 0
Spain
Phone 90071 0
+34 96 386 43 95
Fax 90071 0
Email 90071 0
[email protected]
Contact person for scientific queries
Name 90072 0
Dr Francisco Selva Sarzo
Address 90072 0
Departament de Fisioteràpia
Facultat de Fisioteràpia
Universitat de València
C/ Gascó Oliag, 3
46010 Valencia
Country 90072 0
Spain
Phone 90072 0
+34 96 386 43 95
Fax 90072 0
Email 90072 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?
All individual participant data relating to force and range of motion outcomes will be shared.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
for everyone
Available for what types of analyses?
for all
How or where can data be obtained?
link


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
No additional documents have been identified.