Condition category
Musculoskeletal Diseases
Date applied
25/01/2015
Date assigned
06/02/2015
Last edited
05/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

British School of Osteopathy

Sponsor details

275 Borough High Street
London
SE1 1JE
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes