Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention for Non-specific Chronic Low Back Patients

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Motor Control Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 18 and 60 years. non specific chronic low back (pain for more than 3 months) with pain intensity of at least 3 points measured by pain numerical rating scale (0-10) and disability of at least 6 points in the 24-item Roland Morris Disability Questionnaire (0-24). classified as low or medium risk though StarT Back Screening Tool Exclusion Criteria: cardiovascular and neurological pathologies serious pathology in the spine and pelvic. previous spinal surgery of at least 1 year before the trial period. check-list with the red flags was performed to exclusion classified as high risk through StarT Back Screening Tool, due these patients have high psychological components and needed of specialized psychological attendance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor Control Exercises<br>(Costa LOP et al. 2009; Hodges PW et al. 2009) | Other: Motor Control Exercises<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Numerical Rating Scale (0-10) |  | After Intervention (2 months), 6 months | 
| Disability (measured by 24-item Roland Morris Disability Questionnaire) | Disability will be measured by 24-item Roland Morris Disability Questionnaire | After Intervention (2 months), 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function (Patient Specific Functional Scale (0-10) |  | After Intervention (2 months) | 
| Global Perceived Effect (11-point Global Perceived Effect Scale (-5-+5) | 11-point Global Perceived Effect Scale (-5-+5) | After Intervention (2 months) | 
| Depression (Beck Inventory (0-63) | Beck Inventory (0-63) | After Intervention (2 months) | 
| Kinesiophobia (Tampa Scale for Kinesiophobia (17-68) | Tampa Scale for Kinesiophobia (17-68) | After Intervention (2 months) | 
| Kinesiophobia (Fear Avoidance Beliefs Questionnaire (0-66) | Fear Avoidance Beliefs Questionnaire (0-66) | After Intervention (2 months) | 
| Kinesiophobia (Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100) | Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100) | After Intervention (2 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Instability, Motor Control Exercises, Clinical Tests, Low Back Pain