Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-02-28 @ 7:11 PM
Study NCT ID:
NCT02398760
Status:
COMPLETED
Last Update Posted:
2016-06-14
First Post:
2015-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention
Sponsor:
Universidade Estadual Paulista Júlio de Mesquita Filho
Organization:
Study Overview
Official Title:
Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention for Non-specific Chronic Low Back Patients
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nowadays, the research priority in low back pain area have been find subgroup of patients with the same characteristics that might achieve better outcomes in a specific intervention. However, even though the studies in this area have increased, questions of this nature remaining without an adequate answer, or with limited evidence. Therefore, the investigators propose to examine the ability of clinical tests, developed to assess alterations related to clinical lumbar instability, to identify subgroups of patients with non specific chronic low back pain that may have better outcomes after a motor control exercises intervention.
Detailed Description:
Changes relative to clinical instability are well established in individuals with non specific chronic low back pain. However, in this population, these changes vary widely, characterizing them as an heterogenous group. Motor Control Exercises (MCE) aims to improve the impaired coordination of deep and superficial muscles of the trunk, to reestablish the stability of the lumbar spine reducing the common alterations in this population, and are associated with reduction of pain and disability of patients with non specific chronic low back pain. To specific assessment of the changes found in this population, clinical tests are often used: in the assessment to identify motor control alterations; during intervention as parameter for treatment progress (e.g. to increase exercises difficulty); and after intervention, to ensure that there was normalization of the motor control. There are several clinical tests to assess changes relative to clinical instability, such as: Clinical Classification Scale (CCS) to assess abdominal muscles and the coordination between superficial and deep trunk muscles; Clinical Test of Thoracolumbar Dissociation (CTTD) to assess anterior/posterior tilt while maintain a constant position of thoracolumbar junction; and the Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET) used to detect structural lumbar instability.
Therefore, primary objectives of this study are: to investigate the ability of clinical tests in predict clinical outcomes, pain and disability, in motor control exercises program, and to investigate the association of two or more tests to predict clinical outcomes.
Therefore, primary objectives of this study are: to investigate the ability of clinical tests in predict clinical outcomes, pain and disability, in motor control exercises program, and to investigate the association of two or more tests to predict clinical outcomes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: