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Trial registered on ANZCTR


Registration number
ACTRN12616001127493
Ethics application status
Approved
Date submitted
6/07/2016
Date registered
18/08/2016
Date last updated
13/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Posture and forward head position (FHP) changes after suboccipital inhibition technique application in water polo players.
Scientific title
Posture and forward head position changes after suboccipital inhibition osteopathic technique application (modified by Upledger) in healthy water polo players measured with photogrammetry
Secondary ID [1] 289423 0
nil known
Universal Trial Number (UTN)
U1111-1174-6354
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Forward Head Posture 299096 0
Kyphosis 309649 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299128 299128 0 0
Physiotherapy
Physical Medicine / Rehabilitation 299129 299129 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The suboccipital inhibition technique* will be administered once to each participant
The approximate duration of this technique is 12 minutes. This durantion will be monitored.
The treatment will be administered by a physiotherapist and osteopath (same person) with 6 years experience.
If any subject isn't able to finish the whole protocol, he or she will be excluded.
*Suboccipital inhibition technique (modified by Upledger).
The patient lies on his/her back and the therapist sits behind his/her head.
1. Holding the patient head with both hands and touching the suboccipital tissues with fingertips 2 to 5. Gently, apply intentional force towards atlas posterior arc. Wait while the fingers get deep into the tissues and find the hard bone restriction of atlas.
2. Holding the same finger contacts, flex metacarpo-phalangical joints and straighten interphalangical joints to sustain the head that holds on the fingertips. Apply an intentional force towards glabela to ensure the work is on occipital-atlas space. Wait until head slides and settles on therapist hands.
3. Relax finger contacts and move second fingers to atlas transverse processes projection. Apply a very gentle mechanical distraction between occipital bone and atlas. Wait until tissue is relaxed.
4. Move second finger to join the others. Apply a very gentle transverse mechanical distraction until tissue is relaxed.
5. Apply an intentional cranial traction until viscolasticity is felt.
Intervention code [1] 295012 0
Treatment: Other
Intervention code [2] 295315 0
Prevention
Comparator / control treatment
Patient's head rests on therapist hands for 2 minutes.. No technique will be done.
Control group
Placebo

Outcomes
Primary outcome [1] 298598 0
Forward Head Position (cranio cervical angle) assessed using photogrammetry.
1 centimeter white spheres will be stuck on subject skin to mark anatomical reference points to be used with the Postural Assessment Software (PAS- SAPO).
Timepoint [1] 298598 0
Within 15 minutes after intervention
Secondary outcome [1] 324693 0
Ischiosural flexibility assessed using the Sit and reach test.
The sit and reach box will be used. The centimetric sacale is adjusted to 23 cm at feet position.
Timepoint [1] 324693 0
Within 15 minutes after intervention
Secondary outcome [2] 324694 0
Cervical Mobility assessed using a gravity goniometer: The subject will be sat down.
-Flexion,
-Extension,
-Side bendings
-Rotations, The neck will be flexed to assess the rotation mobility,
Timepoint [2] 324694 0
Within 15 minutes after intervention
Secondary outcome [3] 324696 0
Other postural changes in sagital plane.
Distances between gravity line traced by tragus to acromion assessed using photogrammetry
1 centimeter white spheres will be stuck on subject skin to mark anatomical reference points to be used with the Postural Assessment Software (PAS).
Timepoint [3] 324696 0
photo: Within 15 minutes after intervention
Secondary outcome [4] 325739 0
Horizontality of biacromial line. assessed using photogrammetry
1 centimeter white spheres will be stuck on subject skin to mark anatomical reference points to be used with the Postural Assessment Software (PAS).
Timepoint [4] 325739 0
photo: Within 15 minutes after intervention
Secondary outcome [5] 325740 0
Horizontality of tragus-tragus line. assessed using photogrammetry
1 centimeter white spheres will be stuck on subject skin to mark anatomical reference points to be used with the Postural Assessment Software (PAS).
Timepoint [5] 325740 0
photo: Within 15 minutes after intervention
Secondary outcome [6] 325741 0
Horizontality of bi anterior-superior-iliac-spine line. assessed using photogrammetry
1 centimeter white spheres will be stuck on subject skin to mark anatomical reference points to be used with the Postural Assessment Software (PAS).
Timepoint [6] 325741 0
photo: Within 15 minutes after intervention
Secondary outcome [7] 325742 0
Other postural changes in sagital plane.
Distances between gravity line traced by tragus to external malleolus.
Assessed using photogrammetry
1 centimeter white spheres will be stuck on subject skin to mark anatomical reference points to be used with the Postural Assessment Software (PAS).
Timepoint [7] 325742 0
photo: Within 15 minutes after intervention

Eligibility
Key inclusion criteria
Local, regional and national water polo players
3 or more years playing water polo.
signing informed consent (by legal tutors if under 18)
Minimum age
14 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Acute injury that prevents the application of the technique
Contraindication to performing the technique .
Other reasons that prevent the realization of the full protocol .
Previous muscle- skeletal surgery by cranio- cervical, trunk , spine and / or lower limbs.
Receiving osteopathic treatment in suboccipital region within last month previous to the study.
Consumption of analgesics, muscle relaxants , anti-inflammatory and / or antidepressants in the last 72 hours.
Under 14 years old and 36 or older .

Study design
Purpose of the study
Prevention
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)
Simple randomisation using a randomisation table created by computer software
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
Completed
Date of first participant enrolment
Anticipated
2/09/2016
Actual
3/12/2016
Date of last participant enrolment
Anticipated
Actual
14/06/2017
Date of last data collection
Anticipated
Actual
14/06/2017
Sample size
Target
60
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 7963 0
Spain
State/province [1] 7963 0
Andalucia

Funding & Sponsors
Funding source category [1] 293843 0
Self funded/Unfunded
Name [1] 293843 0
Alvaro Rodriguez Marcano
Country [1] 293843 0
Spain
Primary sponsor type
Individual
Name
Alvaro Rodriguez Marcano
Address
Marcano, Physiotherapy and Osteopathy Clinic.
Avenida de Espera 3
11405 Jerez de la Frontera
Cadiz
Country
Spain
Secondary sponsor category [1] 292681 0
None
Name [1] 292681 0
None
Address [1] 292681 0
None
Country [1] 292681 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295269 0
Madrid School of Osteopathy Ethics Committee
Ethics committee address [1] 295269 0
Ethics committee country [1] 295269 0
Spain
Date submitted for ethics approval [1] 295269 0
13/05/2016
Approval date [1] 295269 0
03/11/2016
Ethics approval number [1] 295269 0

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

Contacts
Principal investigator
Name 66626 0
Mr Alvaro Rodriguez Marcano
Address 66626 0
Marcano, physiotherapy and Osteopathy Clinic
Av Espera 3
11405 Jerez de la Frontera
Cadiz
Country 66626 0
Spain
Phone 66626 0
+34657697583
Fax 66626 0
Email 66626 0
alvaro@marcano.eu
Contact person for public queries
Name 66627 0
Alvaro Rodriguez Marcano
Address 66627 0
Marcano, Physiotherapy and Osteopathy Practice
Av Espera 3
11405 Jerez de la Frontera
Cadiz
Country 66627 0
Spain
Phone 66627 0
+34657697583
Fax 66627 0
Email 66627 0
alvaro@marcano.eu
Contact person for scientific queries
Name 66628 0
Alvaro Rodriguez Marcano
Address 66628 0
Marcano, physiotherapy and Osteopathy Clinic
Av Espera 3
11405 Jerez de la Frontera
Cadiz
Country 66628 0
Spain
Phone 66628 0
+34657697583
Fax 66628 0
Email 66628 0
alvaro@marcano.eu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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