Influence of cranial-sacral osteopathic treatment on the performance of young soccer players

ISRCTN	ISRCTN11632545
DOI	https://doi.org/10.1186/ISRCTN11632545
Secondary identifying numbers	N/A

Submission date: 25/01/2015
Registration date: 06/02/2015
Last edited: 05/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
CSOT is thought to be a complementary approach for the prevention and treatment of dysfunctions and enhancement of health in osteopathy. In sports medicine, cranial sacral treatments have been proposed for the prevention, restoration and optimization of the function of the body. Players’ health condition affects every aspect of their performance ability. According to osteopathic philosophy, structure and function are inter-related and by improving the structure, the function should improve, osteopathic treatments might be a valuable tool to optimise physical performance. The aim in this study is to investigate the effects of CSOT on performance and recovery of young soccer players.

Who can participate?
Healthy boys who play soccer

What does the study involve?
Participants will be randomly allocated to one of two groups. Group 1 (n=20) will be treated with osteopathic cranial-sacral diversified techniques and group 2 will receive a sham intervention for 8 weeks. The effects after CSOT will be compared with those of the sham intervention.

What are the possible benefits and risks of participating?
A benefit might be that participants notice some improvements in their performance. The risks might be physical injury and cardiovascular risks.

Where is the study run from?
Junior Team Futebol Club (Brazil)

When is the study starting and how long is it expected to run for?
From February 2015 to April 2014

Who is funding the study?
British School of Osteopathy (UK)

Who is the main contact?
Ms Patricia Miyuki Hirai

Contact information

Ms Patricia Miyuki Hirai
Scientific

British School of Osteopathy
275 Borough High Street
London
SE1 1JE
United Kingdom

ORCID ID	0000-0003-0358-8033

Study information

Study design	Single-blind randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	Influence of cranial-sacral osteopathic treatment on the performance of young soccer players: a single-blind randomised controlled study
Study objectives	1. Cranial-sacral osteopathic treatments (CSOTs) can be a valuable tool to enhance training recovery, assessed by the repeated sprint ability test (RSAT), heart rate variability (HRV), heart rate and perceived recovery wellbeing, in young soccer players 2. CSOTs can positively influence performance in young soccer players
Ethics approval(s)	British School of Osteopathy Research Ethics committee, 18/06/2014
Health condition(s) or problem(s) studied	Training performance of young soccer player
Intervention	Soccer players will be randomly assigned to one of two treatments for 8 weeks: 1. CSOT: motion analysis of cranial-sacral movements with patient lying supine; areas of dysfunctional motion will receive specific treatment consisting of occipital-sacral rhythm, sphenobasilar and compression of the fourth ventricle techniques applied according to the findings. 2. Sham intervention: standardised light manual contact on the same anatomical regions as the CSOT group, without therapeutic intention; seven serial calculations will be subtracted in silence
Intervention type	Procedure/Surgery
Primary outcome measure	1. Physical performance (RSAT – RSATbest and RSATmean) in the the first, fourth and eighth weeks 2. Perceived recovery wellbeing (training wellbeing diary, adapted from Bompa and Haff, 2009) before every intervention 3. Adaptation aspects (HRV before and after each CSOT and sham procedure) 4. Mean heart rate during the last 30 seconds of exercise
Secondary outcome measures	Verify whether osteopathy is a valuable adjuvant tool to enhance performance in young soccer players
Overall study start date	11/02/2015
Completion date	25/04/2015

Eligibility

Participant type(s)	Healthy volunteer
Age group	Mixed
Sex	Male
Target number of participants	40
Key inclusion criteria	1. Physically and mentally healthy athletes without any symptoms of neuromusculoskeletal pain, injury or illness 2. Soccer players 3. Age 16–18 years 4. Legal guardians’ consent for participation in the study 5. Regular attendance at training sessions and competitive matches for 5 days a week for at least 5 years 6. Defenders (central and external/full-backs and wing-defenders), midfielders (central and wide) and attackers (forwards) 7. Naïve to cranial-sacral osteopathic care 8. Possessing no previous knowledge and experience of cranial-sacral osteopathic procedures 9. No change of medical or physical routine because of the addition of the new procedures
Key exclusion criteria	1. Acute fracture or infections 2. Cancer 3. Signs of progressive neurological deficit 4. Professional soccer athletes 5. Goalkeepers (since technical skills differ significantly from outfield players and have a specific physiological and biomechanical profile [Eirale et al, 2014]) 6. Current illness 7. Suspicion of increased intracranial pressure 8. Cardiac disease 9. Pulmonary diseases 10. Injuries 11. Signs or symptoms of pain or illnesses such as inflammation
Date of first enrolment	11/02/2015
Date of final enrolment	11/02/2015

Locations

Countries of recruitment

Brazil

Study participating centre

Junior Team Futebol Club

Londrina
Brazil

Sponsor information

British School of Osteopathy
University/education

275 Borough High Street
London
SE1 1JE
England
United Kingdom

"ROR"	https://ror.org/05tnja216

Funders

Funder type

University/education

British School of Osteopathy

No information available

Results and Publications

Intention to publish date	30/09/2015
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	1. Data from this research project might be published in future and/or used in other studies. 2. Articles will be prepared and submitted to scientific events from September 2015.
IPD sharing plan