Asymptomatic ConditionNCT03361592
The Immediate Effects of Spinal Manipulative Therapy on Kinetic and Kinematic Symmetry.
A study testing Spinal Manipulative Therapy in people with Asymptomatic Condition, run by University of Lisbon at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Condition
- What is being tested?
- Spinal Manipulative Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 4 Sep 2017to 5 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Asymptomatic Condition
- Being tested
- Spinal Manipulative Therapy, SHAM
- Keywords
- symmetry index, functional performance tests, SMT
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Manipulative TherapyProcedure or surgery
Also called Movement Disorders/therapy, Spinal Manipulation
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.
SHAMProcedure or surgery
Also called Control Group
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetic Symmetry (Lower Limbs Ground Reaction Forces)
Lower Limbs Ground Reaction Forces measured by the force platforms
Measured: 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
Measured: 5 min after lumbar SMT intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start4 Sep 2017
- Primary completion22 Sep 2017
- Study completion5 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled single-blinded study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Bruno Araújo Procópio de Alvarenga, PT, DC, University of Lisbon
- Investigators
- Bruno Alvarenga, Phd, Principal investigator, ULisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361592
- Sponsor's protocol ID
- Ulisboa
- Status last verified
- Apr 2018
- First submitted
- 6 Nov 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03361592
- Acronym / sponsor ID
- Ulisboa
- Conditions
- Asymptomatic Condition
- Keywords
- symmetry index, functional performance tests, SMT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 22 Sep 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled single-blinded study.
| Arm | Type | Receives |
|---|---|---|
| Spinal Manipulative Therapy | Experimental | Procedure: Spinal Manipulative TherapyThe 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. |
| Sham pre-load positioning SMT | Sham comparator | Procedure: SHAMThe 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Manipulative TherapyAlso: Movement Disorders/therapy, Spinal ManipulationLumbar (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. | Procedure or surgery | Spinal Manipulative Therapy |
| SHAMAlso: Control GroupThe "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). | Procedure or surgery | Sham pre-load positioning SMT |
Primary outcome
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
1 secondary outcome
Kinematic Symmetry (Linear Global Joint Centers Vectors Displacement)
Time frame: 5 min after lumbar SMT intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 30555714Alvarenga 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.
- The Biomechanics and Functional Morphology Laboratory (BFML) is a research and education facility within the Faculty of Human Kinetics (FMH) and the University of Lisbon (ULisboa).Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Alvarenga, Phd principal investigator
ULisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulative Therapy in people with Asymptomatic Condition, run by University of Lisbon at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetic Symmetry (Lower Limbs Ground Reaction Forces) (time frame: 5 min after lumbar SMT intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03361592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.