NCT03361592

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2017

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

18 days

First QC Date

November 6, 2017

Last Update Submit

April 30, 2018

Conditions

Keywords

symmetry index, functional performance tests, SMT

Outcome Measures

Primary Outcomes (1)

  • Kinetic Symmetry (Lower Limbs Ground Reaction Forces)

    Lower Limbs Ground Reaction Forces measured by the force platforms

    5 min after lumbar SMT intervention

Secondary Outcomes (1)

  • Kinematic Symmetry (Linear Global Joint Centers Vectors Displacement)

    5 min after lumbar SMT intervention

Study Arms (2)

Spinal Manipulative Therapy

EXPERIMENTAL

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 pre-load positioning SMT

SHAM COMPARATOR

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

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
Spinal Manipulative Therapy
SHAMPROCEDURE

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
Sham pre-load positioning SMT

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants who received medical, surgical or in addition manual interventions prior or during the study, were immediately excluded.
  • Participants who presented with any contraindications to manipulation on spine, which included but was not limited to osteomyelitis, tuberculosis, infectious arthritis, disc extrusion, hemangioma, vertebral malignancy 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 informed consent form, or not agree of the conditions, or did not have conditions to compromise with the schedule, were immediately withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bruno Araújo Procópio de Alvarenga

Lisbon, 1700-228, Portugal

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Asymptomatic Diseases

Interventions

TherapeuticsManipulation, Spinalsalicylhydroxamic acidControl Groups

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesRehabilitationEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Bruno Alvarenga, Phd

    ULisboa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants were initially instructed about the study procedures with therapeutic interventions. After collected data, the participants were asked about the therapeutic intervention, if they are capable to identify which intervention were performed, SMT or SHAM, as parte of study protocol.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled single-blinded study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Student, Physiotherapist and Chiropractor

Study Record Dates

First Submitted

November 6, 2017

First Posted

December 5, 2017

Study Start

September 4, 2017

Primary Completion

September 22, 2017

Study Completion

December 5, 2017

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations