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

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ClinicalTrials.gov Identifier: NCT03361592
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Bruno Araújo Procópio de Alvarenga, PT, DC, University of Lisbon

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.


Condition or disease Intervention/treatment Phase
Asymptomatic Condition Procedure: Spinal Manipulative Therapy Procedure: SHAM Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled single-blinded study.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Immediate Effects of Spinal Manipulative Therapy (SMT) on Kinetic and Kinematic Symmetry on Functional Performance Tests: a Test-retest, Single-blinded, Randomized Controlled Trial.
Actual Study Start Date : September 4, 2017
Actual Primary Completion Date : September 22, 2017
Actual Study Completion Date : December 5, 2017

Arm Intervention/treatment
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
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.
Other Names:
  • Movement Disorders/therapy
  • Spinal Manipulation

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
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).
Other Name: Control Group




Primary Outcome Measures :
  1. Kinetic Symmetry (Lower Limbs Ground Reaction Forces) [ Time Frame: 5 min after lumbar SMT intervention ]
    Lower Limbs Ground Reaction Forces measured by the force platforms


Secondary Outcome Measures :
  1. Kinematic Symmetry (Linear Global Joint Centers Vectors Displacement) [ Time Frame: 5 min after lumbar SMT intervention ]
    Linear Global Joint Centers Vectors Displacement measured by the 3D motion capture system



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361592


Locations
Portugal
Bruno Araújo Procópio de Alvarenga
Lisbon, Portugal, 1700-228
Sponsors and Collaborators
University of Lisbon
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: Bruno Alvarenga, Phd ULisboa

Additional Information:
Responsible Party: Bruno Araújo Procópio de Alvarenga, PT, DC, Phd Student, Physiotherapist and Chiropractor, University of Lisbon
ClinicalTrials.gov Identifier: NCT03361592     History of Changes
Other Study ID Numbers: Ulisboa
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bruno Araújo Procópio de Alvarenga, PT, DC, University of Lisbon:
symmetry index, functional performance tests, SMT

Additional relevant MeSH terms:
Asymptomatic Diseases
Disease Attributes
Pathologic Processes