Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Ms Patricia Miyuki Hirai
ORCID ID
http://orcid.org/0000-0003-0358-8033
Contact details
British School of Osteopathy
275 Borough High Street
London
SE1 1JE
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Influence of cranial-sacral osteopathic treatment on the performance of young soccer players: a single-blind randomised controlled study
Acronym
Study hypothesis
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
British School of Osteopathy Research Ethics committee, 18/06/2014
Study design
Single-blind randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
11/02/2015
Overall trial end date
25/04/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Mixed
Gender
Male
Target number of participants
40
Participant 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
Recruitment start date
11/02/2015
Recruitment end date
11/02/2015
Locations
Countries of recruitment
Brazil
Trial participating centre
Junior Team Futebol Club
Londrina
Brazil
Funders
Funder type
University/education
Funder name
British School of Osteopathy
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
30/09/2015
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary