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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 September 2016
• Main ID: NCT02221609
• Date of registration: 16/08/2014
• Prospective Registration: Yes
• Primary sponsor: Universidade Cidade de Sao Paulo
• Public title: Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
• Scientific title: Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
• Date of first enrolment: October 2014
• Target sample size: 148
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02221609
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Leonardo Costa, PhD
• Affiliation: Universidade Cidade de Sao Paulo

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Low Back Pain

Intervention(s)

Other: Treatment based on Movement System Impairment model

Other: General exercise

Primary Outcome(s)

Disability [Time Frame: 2 months after randomisation]

Pain Intensity [Time Frame: 2 months after randomisation]

Secondary Outcome(s)

Pain Intensity [Time Frame: 4 and 6 months after randomisation]

Disability [Time Frame: 4 and 6 months after randomisation]

Global perceived effect [Time Frame: 2, 4 and 6 months after randomisation]

Secondary ID(s)

17660913.0.0000.5137

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Pontifícia Universidade Católica de Minas Gerais