Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001408471
Ethics application status
Approved
Date submitted
3/01/2016
Date registered
10/10/2016
Date last updated
22/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of global pelvic manipulation on groin pain, hamstring length and piriformis trigger point in football players with range of motion asymmetry of the coxofemoral joint: immediate and post training effect.
Scientific title
In football players with range of motion asymmetry in coxofemoral joint, does the global pelvic manipulation reduce groin pain, hamstring length, and piriformis trigger point compared with placebo manipulation?
Secondary ID [1] 287343 0
None
Universal Trial Number (UTN)
U1111-1173-5753
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Football players with range of motion assymetry (at least 10 degrees) in the coxofemoral joint 295993 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296275 296275 0 0
Physiotherapy
Musculoskeletal 297697 297697 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GLOBAL PELVIC MANIPULATION

Manipulation focused on sacroiliac joint (SIJ) and L5-S1. Used to improve the local movement in those joints. It will be applied bilaterally, with a high speed and low amplitude impulse.

The manipulation will be applied by a Phisiotherapist, with a manual intervention on massage table.

The phisioterapist will manipulate each SIJ once time before training. That intervention will not be repeated.
Intervention code [1] 292673 0
Rehabilitation
Intervention code [2] 293805 0
Treatment: Other
Comparator / control treatment
PLACEBO. Using a not terapeutic intervention to the subject.

Same position of the manipulation without high speed and low ampitud impulse. The football player will be only on the massage table, lying on his side, without physiotherapist intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 295928 0
Groin pain

With algometer FPK-20. Measure on center of both pubic bone.
Timepoint [1] 295928 0
Pre intervention

Post intervention. Immediately after apply manipulation or placebo, before team training session starts..

Post training. After regular football team training is completed.
Primary outcome [2] 295929 0
Hamstring length

Measurement with inclinometer. On the table with the straight leg raise test, inclinometer on the ankle.
Timepoint [2] 295929 0
Pre intervention

Post intervention. Immediately after apply manipulation or placebo, before team training session starts..

Post training. After regular football team training is completed.
Primary outcome [3] 295930 0
Pain threshold piriformis trigger point 1

With algometer FPK-20. Measure on the piriformis proximal.
Timepoint [3] 295930 0
Pre intervention

Post intervention. Immediately after apply manipulation or placebo, before team training session starts..

Post training. After regular football team training is completed.
Secondary outcome [1] 316946 0
Coxofemoral internal rotation movement

With inclinometer. prone position. Bent knees. Inclinometer on the ankle.
Timepoint [1] 316946 0
Pre intervention

Post intervention. Immediately after apply manipulation or placebo, before team training session starts..

Post training. After regular football team training is completed.
Secondary outcome [2] 319699 0
Training effect on coxofemoral joint mobility.

Comparing test results before training, against test results after training. Measure with inclinometer, prone position with bent knees. Inclinometer on the ankle.
Timepoint [2] 319699 0
Post intervention. Immediately after apply manipulation or placebo, before regular team training session starts..

Post training. After regular team training is completed.
Secondary outcome [3] 319700 0
Domintant leg influence on the coxofemoral joint limitation. Compairing internal rotation movement test results, with the dominant leg player (signed on interviwe pre intervention)

Dominant leg player assessed by initial interview. Coxofemoral internal rotation movement measure with inclinometer (described on secondary outcome (1))
Timepoint [3] 319700 0
Pre intervention
Secondary outcome [4] 319701 0
Groin pain history relationship with coxofemoral joint mobility

Interview pre intervention. Asking the history of Groin pain. Comparison with coxofemoral joint internal rotation (measure with inclinometer, described on secondary outcome (1))
Timepoint [4] 319701 0
Pre intervention
Secondary outcome [5] 319704 0
Relationship between coxofemoral joint limitation with player position

Interview pre intervention, four options: goalkeeper, defence, mildfielders, forward player.

Comparison with coxofemoral joint internal rotation (measure with inclinometer, described on secondary outcome (1))
Timepoint [5] 319704 0
Pre intervention
Secondary outcome [6] 319705 0
Relationship between coxofemoral joint limitation and competition level.

We assessed coxofemoral joint limitation with Baseline inclinometer, comparing right/left leg. The difference between both hip joints has to be at least 10 degrees.

Interview: first division, third division, junior championship....)
Timepoint [6] 319705 0
Pre intervention

Eligibility
Key inclusion criteria
- Football players.
- Men
- At least 10 degrees of coxofemoral joint internal rotation asymmetry
- Informed consent signature
Minimum age
14 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Less than 10 degrees of coxofemoral joint internal rotation asimmetry
- Radiological abnormalities of coxofemoral joint.
- Physiotherapy or osteopathic treatments three weeks before- Spine disseases with intervertebral disc affectation
- Acute dissease of sacroiliac joint
- Hamstring injury 4 weeks before
- Contraindication of any study intervention
- Difficulty to finish all the trial

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)
We are going to use the web tool RESEARCH RANDOMIZER (www. randomizer.org).

Urbaniak, G. C., & Plous, S. (2013). Research Randomizer (Version 4.0) [Computer software]. Retrieved on June 22, 2013, from http://www.randomizer.org/

As with most computer-based "random number generators," this program is best described as a "pseudo-random number generator" because the numbers are generated by use of a complex algorithm (seeded by the computer's clock) that gives the appearance of randomness
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2017
Actual
Date of last participant enrolment
Anticipated
30/10/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
115
Accrual to date
Final
Recruitment outside Australia
Country [1] 7495 0
Spain
State/province [1] 7495 0
Madrid

Funding & Sponsors
Funding source category [1] 292617 0
Self funded/Unfunded
Name [1] 292617 0
Miguel Angel Cordero Mendoza
Country [1] 292617 0
Spain
Primary sponsor type
Individual
Name
Miguel Angel Cordero Mendoza
Address
Miguel Angel Cordero Mendoza

C/ Braille, 3, 5 D
28034. Madrid
SPAIN
Country
Spain
Secondary sponsor category [1] 291336 0
None
Name [1] 291336 0
None
Address [1] 291336 0
None
Country [1] 291336 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294095 0
Comite Coordinador de Etica de la Investigacion Biomedica de Andalucia
Ethics committee address [1] 294095 0
Ethics committee country [1] 294095 0
Spain
Date submitted for ethics approval [1] 294095 0
02/01/2016
Approval date [1] 294095 0
14/02/2016
Ethics approval number [1] 294095 0

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

Contacts
Principal investigator
Name 59818 0
Mr Miguel Angel Cordero Mendoza
Address 59818 0
Miguel Angel Cordero Mendoza

C/ Braille, 3, 5 D
28034. Madrid
SPAIN
Country 59818 0
Spain
Phone 59818 0
+34615388993
Fax 59818 0
Email 59818 0
[email protected]
Contact person for public queries
Name 59819 0
Miguel Angel Cordero Mendoza
Address 59819 0
Miguel Angel Cordero Mendoza

C/ Braille, 3, 5 D
28034. Madrid
SPAIN
Country 59819 0
Spain
Phone 59819 0
+34615388993
Fax 59819 0
Email 59819 0
[email protected]
Contact person for scientific queries
Name 59820 0
Miguel Angel Cordero Mendoza
Address 59820 0
Miguel Angel Cordero Mendoza

C/ Braille, 3, 5 D
28034. Madrid
SPAIN
Country 59820 0
Spain
Phone 59820 0
+34615388993
Fax 59820 0
Email 59820 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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