Condition category
Musculoskeletal Diseases
Date applied
24/06/2018
Date assigned
02/07/2018
Last edited
27/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is a constant demand for sports performance enhancement. Changes in the alignment and biology of the spine can affect signals relating to body positioning (proprioception), control of movement and brain interaction, which could then reduce performance in sports. An athlete could be unaware of these changes, because they might not produce any noticeable symptoms. Spinal Manipulative Therapy (SMT), which involves a therapist physically moving the spine, can make adjustments to nerves and other parts of the spine that could influence sports performance.
The aim of this study was to investigate whether SMT can change elite soccer athletes' sprint and agility performance.

Who can participate?
Healthy soccer players aged 18-20

What does the study involve?
The participants are randomly allocated to receive a single SMT or dummy (placebo) manipulation for 10-15 minutes. Immediately before and after the treatment, they do the sprint and agility tests twice.

What are the possible benefits and risks of participating?
There are no expected risks or benefits of participating.

Where is the study run from?
CLIC Salvador, Brazil

When is the study starting and how long is it expected to run for?
January 2012 to April 2017

Who is funding the study?
The study was self-funded by the principal investigator

Who is the main contact?
Marcelo Botelho, quiropraxia@hotmail.com

Trial website

n/a

Contact information

Type

Scientific

Primary contact

Dr MARCELO BOTELHO

ORCID ID

http://orcid.org/0000-0001-7284-2336

Contact details

AV. PROF MAGALHAES NETO
1541
SALA 2015
SALVADOR
41820-011
Brazil

Additional identifiers

EudraCT number

n/a

ClinicalTrials.gov number

n/a

Protocol/serial number

3993

Study information

Scientific title

Spinal biomechanical corrections via Spinal Manipulative Therapy (SMT) can help elite soccer athletes' performance: a randomized controlled trial with internally validated placebo

Acronym

n/a

Study hypothesis

Asymptomatic spinal biomechanical alterations are believed to generate impaired proprioceptive input and motor control and central processing deficits, which could lead to loss of performance. Our hypothesis is that spinal biomechanical correctionsusing Spinal Manipulative Therapy can help soccer athletes' sports performance.

Ethics approval

Ethics and Research Committee at the Instituto Mantenedor de Educação Superior, 12/11/2012, 3993

Study design

Single-centre randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Vertebral subluxation complex (ICD-10: M99.1)

Intervention

20 elite soccer athletes were randomized 1:1 using a coin flip to SMT or placebo. A single intervention (SMT or placebo) was performed, with a total duration of 10-15 min per intervention. Crossover was not performed. The placebo intervention was internally validated.
The sprint test was carried out on a 30-m straight line track, using a system of three photocell devices (Microgate, Bolzano, Italy), one at the beginning, one at 10 m (split time) and the last one at the 30-m mark. The athlete's starting point was with the preferred foot just before the starting line, and it was their own decision when to start the sprint, to avoid reaction time influence. The first barrier of photocells was located right after the starting line. Time recording was started when the athlete's body crossed the photocell barriers. This procedure was repeated twice with a rest interval of 5 minutes. The best value was used for analysis.
The agility test track was 20 m long. Athletes were required to run in a zigzag pattern while crossing four 5-m distance barriers located each at a 100° internal angle from the next. The time was measured by a system of two photocells (Microgate, Bolzano, Italy), one at the beginning of the track and another at the end. The starting athlete position was the same as used for the 30-m run. This procedure was repeated twice with a rest interval of 5 minutes. The best value was used for analysis.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. 10-m and 30-m sprint times immediately before and after the intervention
2. Agility test immediately before and after the intervention

Secondary outcome measures

n/a

Overall trial start date

09/01/2012

Overall trial end date

06/04/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Athletes who train or compete for at least 5 days a week
2. Understood and signed an informed consent form

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

1. Common listed contraindications to SMT, as included in the World Health Organization guidelines, as assessed by a sports medical doctor, including acute fracture, acute infections, neurological deficits, signs of joint instability or pathological ligament laxity
2. Acute musculoskeletal lesions that may prevent the athlete participating in the tests
3. Previously treated using SMT.

Recruitment start date

12/02/2014

Recruitment end date

17/02/2014

Locations

Countries of recruitment

Brazil

Trial participating centre

Fluminense Football Club training facilities
R. Álvaro Chaves, 41 - Laranjeiras
Rio de Janeiro
22231-220
Brazil

Sponsor information

Organisation

N/A

Sponsor details

N/A
N/A
N/A
Brazil

Sponsor type

Not defined

Website

N/A

Funders

Funder type

Not defined

Funder name

N/A

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results to be published in a leading journal of the sports medicine and physiology field.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

25/06/2018

Participant level data

Not expected to be available

Basic results (scientific)

Placebo intervention was internally validated. Athletes that underwent SMT kept the same level of performance for 10- and 30-m sprint times, while placebo ones performed worse. No changes were observed for the agility test immediately after interventions.

Publication list

Publication citations

Additional files

Editorial Notes