Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000168550
Ethics application status
Approved
Date submitted
14/01/2015
Date registered
20/02/2015
Date last updated
27/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a short term osteopathic intervention package on vertical jump and reach height in healthy basketball players: A cross-over design.
Scientific title
The effect of a short term osteopathic intervention on vertical jump and reach height in healthy basketball players with below normal shoulder mobility.
Secondary ID [1] 285966 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Below normal shoulder mobility 293898 0
Condition category
Condition code
Musculoskeletal 294205 294205 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294206 294206 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single treatment of osteopathic manual therapy (OMT) applied to the upper body (shoulder girdle and upper back) administered by a registered, experienced osteopath for 10 minutes duration.

A wash-out period of 7 days between cross-over treatments will be applied.
Intervention code [1] 290941 0
Treatment: Other
Intervention code [2] 290942 0
Rehabilitation
Comparator / control treatment
A single treatment of osteopathic manual therapy (OMT) applied to the legs administered by a supervised final year osteopathy student for 10 minutes duration.
Control group
Active

Outcomes
Primary outcome [1] 293990 0
Sargent vertical Jump and Reach height assessed using Vertec vertical jump equipment. Jump is performed from two foot take-off with counter movement and arm swing allowed.
Timepoint [1] 293990 0
Immediately following treatment (within 10 minutes).
Primary outcome [2] 293991 0
Degree of shoulder extension during jump assessed via angle measurement from video analysis of jumps
Timepoint [2] 293991 0
Immediately following treatment (within 10 minutes).
Secondary outcome [1] 312309 0
Ground reaction force measured via portable force plate. Acts also as a covariate for changes in jump and reach height that occur due to changes in lower limb power production.
Timepoint [1] 312309 0
Immediately following treatment (within 10 minutes).

Eligibility
Key inclusion criteria
Have below normal range of shoulder flexion (<150 degrees) from anatomical position with natural radio-ulnar movement.
Male players: play at a semi-professional competitive level or higher
Female players: compete regularly (throughout season) in a sport/position that involves jumping and reaching for height.
Minimum age
18 Years
Maximum age
37 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous history of shoulder surgery.
Previous shoulder dislocation.
Any shoulder pain that affects shoulder function verbal rating scale (Score of >=1).
Current lower extremity of pelvic injuries that would affect vertical jump.
Any cardiac symptoms, such as heart palpitation, shortness of breath, or chest pain.
Previous or current diagnosis of thoracic outlet syndrome.
Previous or current diagnosis of frozen shoulder.
Neurological symptoms.
Recent (< 6 months prior) or current use of medication which could have musculoskeletal side effects (e.g. aspirin).
Recent (< 1 week prior) or currently receiving any form of manual therapy.
Recent (< 1 week prior) or currently performing any intervention to increase overhead range of motion.

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)
An allocation schedule was produced prior to testing. It was delivered to the testing site on the day of testing. A person not involved with either the intervention or control administration or in the measurement of outcome variables directed participants to receive the correct condition allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomisation schedule was produced for 2 orders of condition (upper and lower body OMT) for the target sample size, using the website http://www.randomization.org, and held by an investigator not involved in the recruitment process.
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
Crossover
Other design features
The conditions are applied one week apart on the same day of the week and time of the day.

The control condition is designed to deliberately obscure the true aims of the study. Participants are not made aware that one of the conditions (the upper body OMT treatment) is designed as the active treatment whilst the other (the lower body OMT treatment) is designed as the control. Therefore, participants are effectively blinded to the existence of a control condition.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 20 male and 20 female basketball players is ideally sought. A minimum sample size of 15 men and 15 women would be required to detect change effect sizes of 0.8, assuming a level of significance of 0.05 and statistical power of 0.8. An effect size of 0.8 equates to a change of between 1 – 3 cm, according to variability reported in a range of previous studies (Sheppard et al., 2011; Tricoli, Lamas, Carnevale, & Ugrinowitsch, 2005; Woolstenhulme, Griffiths, Woolstenhulme, & Parcell, 2006). The additional 5 subjects allows slightly more statistical power and also allows for the possibility of withdrawal from the study.

Two-way ANOVAs will be used to assess difference between conditions for each of the outcome measures. Correlational analysis will be used to determine relationships between changes in jump and reach height and both initial levels and changes in ROM.

Results from the ground reaction force plate will be applied as a covariate in the analysis to control for differences in power generation between participants.

REFERENCES:
Sheppard, J. M., Dingley, A. A., Janssen, I., Spratford, W., Chapman, D. W., & Newton, R. U. (2011). The effect of assisted jumping on vertical jump height in high-performance volleyball players. J Sci Med Sport, 14(1), 85-89. doi: 10.1016/j.jsams.2010.07.006

Tricoli, V., Lamas, L., Carnevale, R., & Ugrinowitsch, C. (2005). Short-term effects on lower-body functional power development: weightlifting vs. vertical jump training programs. J Strength Cond Res, 19(2), 433-437. doi: 10.1519/r-14083.1

Woolstenhulme, M. T., Griffiths, C. M., Woolstenhulme, E. M., & Parcell, A. C. (2006). Ballistic stretching increases flexibility and acute vertical jump height when combined with basketball activity. J Strength Cond Res, 20(4), 799-803. doi: 10.1519/r-18835.1

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/03/2015
Actual
20/06/2015
Date of last participant enrolment
Anticipated
1/04/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6593 0
New Zealand
State/province [1] 6593 0
Auckland region

Funding & Sponsors
Funding source category [1] 290549 0
University
Name [1] 290549 0
Unitec Institute of Technology
Country [1] 290549 0
New Zealand
Primary sponsor type
Individual
Name
Dr Catherine J. Bacon
Address
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 289244 0
None
Name [1] 289244 0
Address [1] 289244 0
Country [1] 289244 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292196 0
Unitec Research Ethics Committee
Ethics committee address [1] 292196 0
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Ethics committee country [1] 292196 0
New Zealand
Date submitted for ethics approval [1] 292196 0
Approval date [1] 292196 0
11/12/2014
Ethics approval number [1] 292196 0
UREC 2014-1093

Summary
Brief summary
This study aims to assess the effects of a single upper body osteopathic manual therapy intervention on vertical jump and reach height in elite basketball players who have some degree of shoulder restriction, compared to a control condition of lower body osteopathic manual therapy. A cross-over design randomises participants to the order in which they receive each of the two conditions, which are administered one week apart at the same time of day and on the same day of the week.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54018 0
Dr Catherine J. Bacon
Address 54018 0
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 54018 0
New Zealand
Phone 54018 0
+64 9 815 6794
Fax 54018 0
Email 54018 0
cbacon@unitec.ac.nz
Contact person for public queries
Name 54019 0
Catherine Bacon
Address 54019 0
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 54019 0
New Zealand
Phone 54019 0
+64 9 815 6794
Fax 54019 0
Email 54019 0
cbacon@unitec.ac.nz
Contact person for scientific queries
Name 54020 0
Catherine J. Bacon
Address 54020 0
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 54020 0
New Zealand
Phone 54020 0
+64 9 815 6794
Fax 54020 0
Email 54020 0
cbacon@unitec.ac.nz

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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