Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
- Conditions
- Low Back Pain
- Interventions
- Other: Treatment based on Movement System Impairment modelOther: General exercise
- Registration Number
- NCT02221609
- Lead Sponsor
- Universidade Cidade de Sao Paulo
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment based on Movement System Impairment based model Treatment based on Movement System Impairment model Treatment based on Movement System Impairment based classification model is composed by patient education, analysis and modification of daily living activities and prescription of specific exercises General exercise General exercise The general exercise program consists of stretching exercises of the trunk and lower limbs muscles and strengthening exercises of the trunk muscles (Hayden et al., 2005; Rainville et al., 2004).
- Primary Outcome Measures
Name Time Method Pain Intensity 2 months after randomisation Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability 2 months after randomisation Disability will be measured by the 24-item Roland Morris Disability Questionnaire
- Secondary Outcome Measures
Name Time Method Pain Intensity 4 and 6 months after randomisation Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability 4 and 6 months after randomisation Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Global perceived effect 2, 4 and 6 months after randomisation Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale
Trial Locations
- Locations (1)
Pontificia Universidade Catolica de Minas Gerais
🇧🇷Belo Horizonte, Minas Gerais, Brazil