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Completed

NCT Number: NCT02398760

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

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Atendimento em Reabilitação e Fisioterapia - FCT/UNESP

Presidente Prudente, São Paulo, 957, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motor control exercises

Other

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.

Primary outcomes

  1. Pain (Numerical Rating Scale (0-10)

    Time frame: After Intervention (2 months), 6 months

  2. Disability (measured by 24-item Roland Morris Disability Questionnaire)

    Time frame: After Intervention (2 months), 6 months

    Disability will be measured by 24-item Roland Morris Disability Questionnaire

Secondary outcomes

  1. Function (Patient Specific Functional Scale (0-10)

    Time frame: After Intervention (2 months)

  2. Global Perceived Effect (11-point Global Perceived Effect Scale (-5-+5)

    Time frame: After Intervention (2 months)

    11-point Global Perceived Effect Scale (-5-+5)

  3. Depression (Beck Inventory (0-63)

    Time frame: After Intervention (2 months)

    Beck Inventory (0-63)

  4. Kinesiophobia (Tampa Scale for Kinesiophobia (17-68)

    Time frame: After Intervention (2 months)

    Tampa Scale for Kinesiophobia (17-68)

  5. Kinesiophobia (Fear Avoidance Beliefs Questionnaire (0-66)

    Time frame: After Intervention (2 months)

    Fear Avoidance Beliefs Questionnaire (0-66)

  6. Kinesiophobia (Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)

    Time frame: After Intervention (2 months)

    Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)

Other outcomes

  1. Clinical Classification Scale (CCS)

    Time frame: After Intervention (2 months)

    To assess abdominal muscles coordination (0-10)

  2. Thoracolumbar Dissociation Clinical Test (TDCT)

    Time frame: After Intervention (2 months)

    To assess thoracolumbar dissociation (0-10)

  3. Changes Thickness of abdominal muscles (Transversus Abdominis, Internal and External Oblique) Measured by Ultrasound Images

    Time frame: After Intervention (2 months)

    Measured by Ultrasound Images made with a 7.5-MHz linear transducer (Siemens, Sonoline Sienna, Issaquah, WA, USA)

  4. Structural Lumbar Instability (Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET)

    Time frame: After Intervention (2 months)

    Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET)

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 26, 2015
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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