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CompletedNCT03361592Updated May 3, 2018

The Immediate Effects of Spinal Manipulative Therapy on Kinetic and Kinematic Symmetry.

An interventional study of Spinal Manipulative Therapy and SHAM in Asymptomatic Condition, sponsored by University of Lisbon. Completed at 1 site in Portugal. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-03.

Sponsored by University of Lisbon · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

Athletes have been exposed to an ever increasing training load and subsequent biomechanical overload due to a constant demand for performance enhancement. As a result, it is 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 muscle strength, range of motion, and symmetry, what could potentially influence sports performance.

Spinal Manipulative Therapy (SMT) is a safe and effective therapy for musculoskeletal disorders that has been increasingly utilized in sports. 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.

Kinetic and kinematic symmetry can be measured in commonly utilized physical functional tests often used as indicators of athlete's performance. Symmetry Index calculation is used to verify bilateral asymmetries in static and dynamic tests.

Read the detailed description

Therefore, the objective of this randomized controlled trial study is to measure the immediate effects of lumbar SMT on kinetic and kinematic symmetry of asymptomatic athletes, through of the use of three commonly used functional tests: Static posture, Free Squat, and Countermovement Jump (CMJ) are often used as indicators of athlete's performance. These quantitative data is important to assess training effectiveness and prevention/ rehabilitation programs outcomes. To our knowledge this is the first study on literature that measured the immediate effects of SMT on kinetic and kinematic symmetry.

02

Conditions studied

  • Asymptomatic Condition

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Keywords

  • symmetry index, functional performance tests, SMT
03

In context

Asymptomatic Diseases

38 studies on the registry are indexed under Asymptomatic Diseases; 8 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 28 interventional studies indexed under Asymptomatic Diseases.

Browse Asymptomatic Diseases studies →

Lead sponsor

University of Lisbon is the lead sponsor of 40 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

The inclusion criteria for sample followed the assumptions below:

  • All young student participants had to be of both sexes, age between 18-35 years old.
  • All participants had to be pain free or asymptomatic, with regards to low back pain, in order to create homogeneity within the study sample.
  • All participants had to have at least a minimal score, (low level) of physical activity, evaluated by (IPAQ) questionnaire (International Physical Activity Questionnaire). This was done on the argument that the minimal score, already shows that the participants were minimally physically active. This also contributed in an indirect way to assure a certain degree of sample homogeneity, scoring the minimal level of physical activity to include in the study;
  • All participants were required to show the subluxations or vertebral dysfunctions in their lumbar spine, detected by motion palpation. Through the purposive sampling, was allowed participants to officially take part in the study.

Exclusion criteria

Exclusion Criteria:

The exclusion criteria for sample followed the assumptions below:

  • Participants who received medical, surgical or in addition manual interventions prior or during the study, were immediately excluded.
  • Participants who presented with any to manipulation on spine, which included but was not limited to osteomyelitis, tuberculosis, infectious arthritis, disc extrusion, hemangioma, vertebral and advanced spondylolisthesis
  • Participants who have participating of sports competitions or change in training routine during the collecting data, was immediately withdraw from the study.;
  • Participants with no vertebral dysfunction in the palpated lumbar joints were excluded of the study;
  • Participants who did not sign the form, or not agree of the conditions, or did not have conditions to compromise with the schedule, were immediately withdraw from the study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Spinal Manipulative Therapy

    The participants assigned to the intervention group received the procedure Lumbar (SMT) was performed after baseline measurements, using Diversified techniques, aiming to correct vertebral dysfunctional segments after clinical assessment. Participants were asked to lay down prone on, to perform spinal motion palpation analysis was performed in order to evaluate the presence of dysfunction in vertebral segments of lumbar spine.

    Procedure: Spinal Manipulative Therapy

  • Sham comparator
    Sham pre-load positioning SMT

    The participants assigned to the control group received the procedure "Sham" (pre-load positioning MVT). The Sham (SMT) was performed with participant body positioning in the lateral position, as the SMT intervention. The doctor followed the participant through the same position of (SMT) intervention, using the maintenance of set-up position, but no manipulative thrust was delivered. The therapist applied minimal pressure and slid their hands across the skin to mimic the manipulative trust. The position was maintained for approximately 1 minute in total, 30 seconds on each side, and none of force or researcher body weight were putted in this procedure, only minimal pressure common to stabilize the set up position of (SMT).

    Procedure: SHAM

Interventions

  • ProcedureSpinal Manipulative Therapy

    Lumbar (SMT) was performed using Diversified techniques, aiming to correct vertebral dysfunctional lumbar segments. Participants were asked to lay down prone on, to perform spinal motion palpation analysis was in order to evaluate the presence of dysfunction in vertebral segments of lumbar spine.

    Also known as: Movement Disorders/therapy, Spinal Manipulation

  • ProcedureSHAM

    The "SHAM" (pre-load positioning SMT) was performed with participant body positioning in the lateral position, as the SMT intervention. The doctor followed the participant through the same position of (SMT) intervention, using the maintenance of set-up position, but no manipulative thrust was delivered. The therapist applied minimal pressure and slid their hands across the skin to mimic the manipulative trust. The position was maintained 30 seconds on each side, and none of force or researcher body weight were putted in this procedure, only minimal pressure common to stabilize the set up position of (SMT).

    Also known as: Control Group

06

What researchers measure

Primary outcomes

  1. Kinetic Symmetry (Lower Limbs Ground Reaction Forces)

    Lower Limbs Ground Reaction Forces measured by the force platforms

    Time frame: 5 min after lumbar SMT intervention

Secondary outcomes

  1. Kinematic Symmetry (Linear Global Joint Centers Vectors Displacement)

    Linear Global Joint Centers Vectors Displacement measured by the 3D motion capture system

    Time frame: 5 min after lumbar SMT intervention

07

Study locations

1 site
  • Bruno Araújo Procópio de Alvarenga
    Lisbon, 1700-228, Portugal
08

References and documents

Publications

  • Alvarenga BAP, Fujikawa R, Joao F, Lara JPR, Veloso AP. The effects of a single session of lumbar spinal manipulative therapy in terms of physical performance test symmetry in asymptomatic athletes: a single-blinded, randomised controlled study. BMJ Open Sport Exerc Med. 2018 Nov 28;4(1):e000389. doi: 10.1136/bmjsem-2018-000389. eCollection 2018. PubMed 30555714 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Sep 2017, 0 months.

Of 17 interventional studies with no phase under Asymptomatic Diseases, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's 0 months is below that.

Asymptomatic Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2017
First posted
Dec 5, 2017
StartActual
Sep 4, 2017
Primary completionActual
Sep 22, 2017
CompletionActual
Dec 5, 2017
Last update
May 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03361592
Lead sponsor
University of Lisbon
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Responsible party
Bruno Araújo Procópio de Alvarenga, PT, DC (Phd Student, Physiotherapist and Chiropractor, University of Lisbon) — Principal investigator
First posted
Dec 5, 2017
Start date
Sep 4, 2017
Primary completion
Sep 22, 2017
Completion
Dec 5, 2017
Last update
May 3, 2018

Study contacts

Bruno Alvarenga, Phd
principal investigator · ULisboa

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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