Centro de Atendimento em Reabilitação e Fisioterapia - FCT/UNESP
Presidente Prudente, São Paulo, 957, Brazil
NCT Number: NCT02398760
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Presidente Prudente, São Paulo, 957, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects performed 8 weeks of motor control exercises intervention, 2 weekly 1 hour per session, instructed by trained physiotherapists to apply this program following a protocol developed in programs previously reported (Costa et al. 2009; Hodges et al. 2009). The first stage aims to improve the activity of muscles that have poor control and reduce overactivity of superficial muscles, previously assessed, through drawing in maneuver with feedback real-time ultrasound and via palpation. The second stage of the treatment involved more functional exercises, first using static and then dynamic tasks.
Time frame: After Intervention (2 months), 6 months
Time frame: After Intervention (2 months), 6 months
Disability will be measured by 24-item Roland Morris Disability Questionnaire
Time frame: After Intervention (2 months)
Time frame: After Intervention (2 months)
11-point Global Perceived Effect Scale (-5-+5)
Time frame: After Intervention (2 months)
Beck Inventory (0-63)
Time frame: After Intervention (2 months)
Tampa Scale for Kinesiophobia (17-68)
Time frame: After Intervention (2 months)
Fear Avoidance Beliefs Questionnaire (0-66)
Time frame: After Intervention (2 months)
Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)
Time frame: After Intervention (2 months)
To assess abdominal muscles coordination (0-10)
Time frame: After Intervention (2 months)
To assess thoracolumbar dissociation (0-10)
Time frame: After Intervention (2 months)
Measured by Ultrasound Images made with a 7.5-MHz linear transducer (Siemens, Sonoline Sienna, Issaquah, WA, USA)
Time frame: After Intervention (2 months)
Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET)
Universidade Estadual Paulista Júlio de Mesquita Filho
Other
Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention for Non-specific Chronic Low Back Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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