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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02398760
Enrollment
68
Registered
2015-03-26
Start date
2014-07-31
Completion date
2016-02-29
Last updated
2016-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

Low Back Pain, Clinical Instability, Motor Control Exercises, Clinical Tests

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.

Interventions

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.

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Universidade Estadual Paulista Júlio de Mesquita Filho
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain (Numerical Rating Scale (0-10)After Intervention (2 months), 6 months
Disability (measured by 24-item Roland Morris Disability Questionnaire)After Intervention (2 months), 6 monthsDisability will be measured by 24-item Roland Morris Disability Questionnaire

Secondary

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

Other

MeasureTime frameDescription
Changes Thickness of abdominal muscles (Transversus Abdominis, Internal and External Oblique) Measured by Ultrasound ImagesAfter Intervention (2 months)Measured by Ultrasound Images made with a 7.5-MHz linear transducer (Siemens, Sonoline Sienna, Issaquah, WA, USA)
Clinical Classification Scale (CCS)After Intervention (2 months)To assess abdominal muscles coordination (0-10)
Thoracolumbar Dissociation Clinical Test (TDCT)After Intervention (2 months)To assess thoracolumbar dissociation (0-10)
Structural Lumbar Instability (Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET)After Intervention (2 months)Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026