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

NCT02221609 | Completed

• 1 other identifier: 17660913.0.0000.5137
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low Back Pain, Mechanical Low Back Pain, Low Back Ache, Low Backache, Lower Back Pain, Lumbago

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

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

  2 months after randomisation

• Disability

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

  2 months after randomisation

Secondary Outcomes (3)

• Pain Intensity

  4 and 6 months after randomisation

• Disability

  4 and 6 months after randomisation

• Global perceived effect

  2, 4 and 6 months after randomisation

Study Arms (2)

Treatment based on Movement System Impairment based model

EXPERIMENTAL

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

Other: Treatment based on Movement System Impairment model

General exercise

ACTIVE COMPARATOR

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).

Other: General exercise

Interventions

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.

Treatment based on Movement System Impairment based model

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.

General exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Pontifícia Universidade Católica de Minas Gerais: collaborator

Study Sites (1)

Pontificia Universidade Catolica de Minas Gerais

Belo Horizonte, Minas Gerais, 30535-901, Brazil

Location

Related Publications (5)

• 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.

  PMID: 21694556 BACKGROUND

• 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.

  PMID: 16034851 BACKGROUND

• 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.

  PMID: 14749199 BACKGROUND

• 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.

  PMID: 31230988 DERIVED

• 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.

  PMID: 29077963 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Leonardo Costa, PhD

  Universidade Cidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd candidate

Study Record Dates

• First Submitted: August 16, 2014
• First Posted: August 20, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-08

Locations

BR (1)