- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03361592
The Immediate Effects of Spinal Manipulative Therapy on Kinetic and Kinematic Symmetry.
Immediate Effects of Spinal Manipulative Therapy (SMT) on Kinetic and Kinematic Symmetry on Functional Performance Tests: a Test-retest, Single-blinded, Randomized Controlled Trial.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lisbon, Portugal, 1700-228
- Bruno Araújo Procópio de Alvarenga
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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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:
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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).
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinetic Symmetry (Lower Limbs Ground Reaction Forces)
Time Frame: 5 min after lumbar SMT intervention
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Lower Limbs Ground Reaction Forces measured by the force platforms
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5 min after lumbar SMT intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinematic Symmetry (Linear Global Joint Centers Vectors Displacement)
Time Frame: 5 min after lumbar SMT intervention
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Linear Global Joint Centers Vectors Displacement measured by the 3D motion capture system
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5 min after lumbar SMT intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bruno Alvarenga, Phd, ULisboa
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ulisboa
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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