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
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
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