Clinical trial NCT02221609: Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
Official title: Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain, Mechanical Low Back Pain, Low Back Ache, Low Backache, Lower Back Pain, Lumbago
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Pontifícia Universidade Católica de Minas Gerais
First posted: 2014-08-20
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity
timeFrame: 2 months after randomisation
measure: Disability
timeFrame: 2 months after randomisation
Secondary outcomes:
measure: Pain Intensity
timeFrame: 4 and 6 months after randomisation
measure: Disability
timeFrame: 4 and 6 months after randomisation
measure: Global perceived effect
timeFrame: 2, 4 and 6 months after randomisation
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Pontificia Universidade Catolica de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Universidade Cidade de Sao Paulo
name: Leonardo Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
citation: Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
citation: Rainville J, Hartigan C, Martinez E, Limke J, Jouve C, Finno M. Exercise as a treatment for chronic low back pain. Spine J. 2004 Jan-Feb;4(1):106-15. doi: 10.1016/s1529-9430(03)00174-8.
citation: Azevedo DC, Ferreira PH, Santos HO, Oliveira DR, Souza JVL, Costa LOP. Baseline characteristics did not identify people with low back pain who respond best to a Movement System Impairment-Based classification treatment. Braz J Phys Ther. 2020 Jul-Aug;24(4):358-364. doi: 10.1016/j.bjpt.2019.05.006. Epub 2019 Jun 13.
citation: Azevedo DC, Ferreira PH, Santos HO, Oliveira DR, de Souza JVL, Costa LOP. Movement System Impairment-Based Classification Treatment Versus General Exercises for Chronic Low Back Pain: Randomized Controlled Trial. Phys Ther. 2018 Jan 1;98(1):28-39. doi: 10.1093/ptj/pzx094. No abstract available.