Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12614000332628
Ethics application status
Approved
Date submitted
4/03/2014
Date registered
27/03/2014
Date last updated
27/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a soft-tissue technique on shoulder functional profile in nonprofessional tennis players
Scientific title
Influence of an osteopathic soft-tissue technique on the glenohumeral range of motion and shoulder rotator muscle strength in nonprofessional competitive tennis players: Immediate effects and after 3 weeks.
Secondary ID [1] 284192 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder sport-specific adaptations 291297 0
Condition category
Condition code
Musculoskeletal 291647 291647 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291719 291719 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Osteopathic soft-tissue technique on the dominant shoulder will be applied once for 10 minutes.
The player will sit on the table, he will put the dominant hand on the non dominant shoulder, keeping the arm in a horizontal plane. The therapist will be behind the player, he will stabilize the player's trunk with his thorax. With the first corner of the internal hand, he immobilizes the scapula and the collarbone of player's dominant shoulder. With the first corner of the external hand, he seizes the axillary crease.
The technic will be composed of three phases :
1. Exaggeration:
The player will low the elbow downward until the therapist will feel the tension in the first corner of the internal hand. The player will make a deep costal inspiration followed by an apnea, the therapist will wait then for the soft-tissue relaxation. The therapist could meet several barriers which he will exceed gradually during the time of exaggeration.
2. Correction :
The player will make a light rotation of trunk to non dominant side and the therapist will make a counter strain with the external hand, putting in tension glenohumeral elastic tissues. The patient will raise the elbow until the therapist feels tension, player will then make a deep costal expiration followed by an apnea. The therapist will wait for the soft-tissue relaxation and will progress in the same way towards the internal rotation by exceeding the tissular barriers.
3. Consolidation :
The previous parameters will be kept, the subject will make a deep costal inspiration followed by an apnea, the therapist will wait for the soft-tissue relaxation and he will put off his hands on a costal inspiration of the patient.
Intervention code [1] 288887 0
Prevention
Comparator / control treatment
The player will sit on the table, the therapist will be behind him with the internal hand on the dominant shoulder, he will take the player's dominant hand with his external hand. The therapist will apply passive movements in adduction (once), external circumduction (three times) and maximal internal rotation (twice).
Control group
Placebo

Outcomes
Primary outcome [1] 291574 0
Glenohumeral internal/external range of motion will be measured using a standard manual goniometer, in the supine position with the arm abducted 90 degrees.
Timepoint [1] 291574 0
baseline, after the osetopathic soft-tissue intervention, and after 3 weeks
Secondary outcome [1] 307095 0
Shoulder external and internal rotator muscle strength will be measured using a hand-held dynamometer, in the supine position with the arm abducted 90 degrees.
Timepoint [1] 307095 0
Baseline, after the osteophatic soft-tissue technique, after 3 weeks

Eligibility
Key inclusion criteria
healthy nonprofessional competitive tennis players
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
dominant shoulder pain or injury

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)
The tennis players will be contacted by phone
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The block random allocation will be applied
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
The mean and standard deviation of each outcome parameter will be calculated. Then inferential statistical tests will be performed, in particular Analysis of Variance with one independant factor (two groups) and three repeated measurements. Following the osteopathic intervention, we attempt to find an increase by 5 +/- 5 degrees of the glenohumeral internal rotation. Based on 20 subjects, the a priori statistical power will be equal to 99% and the effect size would be equal to 1.0.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5860 0
France
State/province [1] 5860 0
rhone

Funding & Sponsors
Funding source category [1] 288816 0
University
Name [1] 288816 0
UFRSTAPS - Centre de Recherche et d'Innovation sur le Sport - EA 647
Country [1] 288816 0
France
Primary sponsor type
University
Name
Universite Claude Bernard Lyon 1
Address
UFRSTAPS - Centre de Recherche et d'Innovation sur le Sport - EA 647
27-29, boulevard du 11 novembre 1918
69622 VILLEURBANNE cedex
France
Country
France
Secondary sponsor category [1] 287513 0
None
Name [1] 287513 0
Address [1] 287513 0
Country [1] 287513 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290660 0
Comite de Protection des Personnes SUD EST II
Ethics committee address [1] 290660 0
Ethics committee country [1] 290660 0
France
Date submitted for ethics approval [1] 290660 0
Approval date [1] 290660 0
05/05/2011
Ethics approval number [1] 290660 0

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

Contacts
Principal investigator
Name 46662 0
A/Prof ROGOWSKI Isabelle
Address 46662 0
UCB Lyon 1 - UFRSTAPS
Centre de Recherche et d'Innovation sur Sport - EA 647
27-29, bd du 11 novembre 1918
69622 VILLEURBANNE Cedex
Country 46662 0
France
Phone 46662 0
+33 4 72 43 28 48
Fax 46662 0
Email 46662 0
[email protected]
Contact person for public queries
Name 46663 0
CREVEAUX Cecile
Address 46663 0
Isosteo
13 Chemin du Petit Bois
69130 ECULLY
Country 46663 0
France
Phone 46663 0
+33 6 10 87 13 47
Fax 46663 0
Email 46663 0
[email protected]
Contact person for scientific queries
Name 46664 0
ROGOWSKI Isabelle
Address 46664 0
UCB Lyon 1 - UFRSTAPS
Centre de Recherche et d'Innovation sur Sport - EA 647
27-29, bd du 11 novembre 1918
69622 VILLEURBANNE Cedex
Country 46664 0
France
Phone 46664 0
+33 4 72 43 28 48
Fax 46664 0
Email 46664 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.