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Completed

NCT Number: NCT02221609

Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial

The objective of this study is to investigate the efficacy of a treatment based on Movement System Impairment based classification (MSI) model in patients with chronic non-specific low back pain.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontificia Universidade Catolica de Minas Gerais

Belo Horizonte, Minas Gerais, 30535-901, Brazil

About this study

The subjects will be recruited from orthopedic outpatient clinics as well from the community. The examiner will screen the eligibility of each subject based on the eligibility criteria. All eligible subjects will receive information about the study and will sign an informed consent form before participating in the study.

The examiner will collect the baseline data prior to randomisation. This examiner will be blinded to patients' allocation to treatment groups. The subjects will be randomly allocated to one of two groups (treatment based on MSI model or general exercise) using a computer-generated randomisation schedule conducted by a study researcher who will not be involved with the patients and assessment of outcomes. Participant allocation will be kept in a sealed opaque envelopes using a random numerical sequence. The examiner, responsible for the treatment will open the envelope in front of the patient and will communicate him about which treatment group he will be part of. The clinical outcomes of this study will be assessed before, after the treatment (2 months) and at 4 and 6 months after randomisation.

Descriptive analyses will be done to check for data normality. The between-group comparisons to obtain the mean effects of the treatments will be conducted by means of interaction terms (group versus time interactions) using Linear Mixed Models. All data will be given to a statistician who will perform the statistical analysis in coded form. The statistical analysis will be done according to the principles of intention to treat. The SPSS 19 and SigmaPlot 10 will be used for these analyses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects of both genders between 18 and 65 years of age with chronic non-specific LBP (pain for more than 3 months) with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale
  • Subjects must be able to stand and walk independently
  • Subjects must be able to read in Portuguese

Exclusion criteria

  • Subjects with any contraindication to physical exercise according to the guidelines of the American College of Sports Medicine
  • Subjects with severe depression (measured by depression, anxiety and stress scale - DASS)
  • Subjects with serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis), nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others), serious cardiorespiratory diseases, previous back surgery or pregnancy.
  • Subjects that cannot be classified into any of the five categories of the Movement System Impairment model upon initial assessment

Treatment and study plan

Treatment based on Movement System Impairment model

Other

The analysis and modification of daily activities will be performed by identifying and analyzing the patients activities that provoke their symptoms. The patient will be taught on how to correct his posture and limit the movements that increase the amount of stress on the lumbar spine. The prescription of specific exercises is done based on the patient's classification into one of 5 categories of the MSI model. These exercises consist of practicing the movement tests performed at the initial assessment in a corrected form, emphasizing the control of the lumbar spine movement and increasing movement on the adjacent joints. Patients will also advised to repeat the exercises at home at least once a day. 12 treatment sessions are planned for each patient (2 sessions per week during the first 4 weeks and 1 session per week during the last 4 weeks). Each treatment session has an estimated duration of 45-60 minutes. Patients will register their home exercise in an exercise diary.

general exercise

Other

The general exercise program consists of 12 treatment sessions with estimated duration between 45-60 minutes per session (2 sessions per week for the first 4 weeks and 1 session per week in last 4 weeks). Each session is also done individually by a trained physical therapist. The patients perform an exercise program that starts with a 5-minutes warm-up followed by stretching exercises. Those stretching exercises address the six directions of lumbar motion and the lower limbs muscles. The patient also performs strengthening exercises of the trunk muscles. Based on correct performance of the exercises, the subject may progress through increased load as tolerated. He is also advised to perform these exercises at home and receive figures of the exercises with written instructions. The exercise program will be adapted according to American College of Sports Medicine recommendations (Garber et al., 2011). Patients will register their home exercise in an exercise diary.

Primary outcomes

  1. Pain Intensity

    Time frame: 2 months after randomisation

    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  2. Disability

    Time frame: 2 months after randomisation

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

Secondary outcomes

  1. Pain Intensity

    Time frame: 4 and 6 months after randomisation

    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  2. Disability

    Time frame: 4 and 6 months after randomisation

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

  3. Global perceived effect

    Time frame: 2, 4 and 6 months after randomisation

    Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Pontifícia Universidade Católica de Minas Gerais

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2014
Registry last updated
Aug 25, 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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