Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/12/2017
Date assigned
12/12/2017
Last edited
12/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
With the increase of the competitiveness and continuous search for the best performance, several athletes have been suffering repeated with biomechanics overload, creating muscle problems that negatively influence muscle strength and range of motion, affecting physical and sports performance, in training or competitions routine. This reality is considered problematic and generates a wide area of interest, with a continuous demand for technologies and therapeutics options, in favor of physical performance enhancement and prevention of injuries in athletes of different levels, conditions and sports. Spinal manipulation (a therapy that is performed on the spine by chiropractors) combines moving and jolting joints and massaging. Currently very little is known about the effects of spinal manipulative therapy in terms of performance tests symmetry on asymptomatic athletes. The aim of this study is to measure lower limbs reactions forces symmetry of athletes before and after lumbar SMT, through of the use of commonly used performance tests.

Who can participate?
Athletes aged 18 to 35 older who have biomechanical dysfunction.

What does the study involve?
Participant undergoes a Performance Test Assessment before and after receiving single session of lumbar (SMT). Participants are assessed for their balance, symmetry and their reaction forces.

What are the possible benefits and risks of participating?
Participants may benefit from improvements in their symptoms. Participants may experience discomfort or injury during the SMT treatment.

Where is the study run from?
University of Lisbon (Portugal)

When is the study starting and how long is it expected to run for?
February 2017 to November 2017

Who is funding the study?
Minister of Education Brazil – CAPES (Brazil)

Who is the main contact?
Professor Bruno Alvarenga (Public)

Trial website

Contact information

Type

Public

Primary contact

Prof Bruno Alvarenga

ORCID ID

Contact details

Faculty of Human Kinetics - FMH (Biomechanics and Functional Morphology Laboratory (BFML) University of Lisbon
Estrada da Costa
Lisbon
1499-002
Portugal

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01

Study information

Scientific title

Changes in lower limbs reaction forces symmetry after lumbar Spinal Manipulative Therapy (SMT) in asymptomatic athletes: A Pilot Study

Acronym

Study hypothesis

Athletes have been exposed to an increasing training load and subsequent biomechanical overload due to a constant demand for performance enhancement. In this sense are observed an increased rate of musculoskeletal problems, including spinal biomechanical dysfunctions that are often asymptomatic. These dysfunctions are believed to negatively influence a wide range of mechanical and physiological parameters such as symmetry. Our hypothesis is if have causal association between lumbar SMT intervention and immediate changes of neuro-musculoskeletal system on performance tests assessments, namely in lower limbs reaction forces symmetry.

Ethics approval

Ethics Committee FMH (Faculty of Human Kinetics) - University of Lisbon, 19/09/2017, ref: 31/2017

Study design

Pilot study interventional non-randomised single-session single-centre open label trial subgroup analysis

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information

Condition

Asymptomatic conditions were required of athletes participants.

Intervention

Each participant undergoesa clinical and physical evaluation performed by one experienced health professional, to verify suitability for inclusion according to the eligibility criteria.

Lumbar SMT is performed on athletes participants between functional performance tests assessment, using Diversified techniques aiming to correct vertebral dysfunctional segments after clinical assessment.

Participants are asked to lay down prone on for spinal motion palpation analysis was performed in order to evaluate the presence of dysfunction in vertebral segments of lumbar spine . After that, SMT is performed with the athlete laying sideways while correction was done contacting the transverse process (mammillary) of the lumbar vertebrae, performing the lumbar roll technique, in all participants. SMT purpose is to correct spinal joints biomechanical dysfunctions using a high-velocity, low-amplitude movement, applied at the paraphysiological space, beyond the passive joint range of motion.

Intervention type

Phase

Drug names

Primary outcome measure

Lower Limbs Ground Reaction Forces measured by the force platforms 5 minytes after lumbar SMT intervention.

Secondary outcome measures

Kinetic Symmetry is measured using Symmetry Index (SI) at 5 min after lumbar SMT intervention.

Overall trial start date

15/02/2017

Overall trial end date

15/11/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Athletes who presented asymptomatic lumbar biomechanical dysfunction
2. From any gender
3. Ages between 18-35 years old

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

13

Participant exclusion criteria

1. Athletes with age superior to 35 years old
2. Have had any changes in their training routine or competition during the study
3. Those with previous spine surgery
4. Being treated at any time with manual therapy during the study

Recruitment start date

15/03/2017

Recruitment end date

15/05/2017

Locations

Countries of recruitment

Portugal

Trial participating centre

University of Lisbon
Biomechanics and Functional Morphology Laboratory Faculty of Human Kinetics - FMH Estrada da Costa - Dafundo
Lisbon
1499-002
Portugal

Sponsor information

Organisation

University of Lisbon

Sponsor details

Faculty of Human Kinetics (FMH)
Biomechanics and Functional Morphology Laboratory (FMH)
Estrada da Costa
Lisbon
1499-002
Portugal

Sponsor type

University/education

Website

http://neuromechanics.fmh.ulisboa.pt/

Funders

Funder type

Government

Funder name

Minister of Education Brazil – CAPES

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned submisision to publications in a high-impact peer reviewed journal. For it, our biomechanics laboratory team support the procedures and decisions for new approaches, and encourage to submit for registrations and submissions in international platforms, according manuscript publications recommendations. In this sense we expect to follow all requirements to submit to scientific journals about the theme and share consistent and relevant results for all public community.

Also through scientific presentations in congresses and conferences, our team would like to submit and present our work by Biomechanics and Functional Morphology Laboratory team (BFML) - University of Lisbon. Our common research interest is related development of experimental methodologies, modeling and simulation for the study of mechanical load on the musculoskeletal system; and also related on investigation of biomechanics effects of the application of Spinal Manipulative Therapy in recreational and elite athletes.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from the study contact. Each individual data (Individuals’ biomechanical outcomes will be presented for study participants, showing outcomes related to performances tests symmetry and therapeutic intervention), will be share, starting from day 15/12/2017, under previous communication and solicitation by study contact responsable personal, as indicated.

Intention to publish date

12/12/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes