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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Treatment based on Movement System Impairment model
General exercise
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Mechanical Low Back Pain, Low Back Ache, Low Backache, Lower Back Pain, Lumbago

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pontificia Universidade Catolica de Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment based on Movement System Impairment based model

General exercise

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability
Disability will be measured by the 24-item Roland Morris Disability Questionnaire

Secondary Outcome Measures

Pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Global perceived effect
Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

Full Information

First Posted
August 16, 2014
Last Updated
August 23, 2016
Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Pontifícia Universidade Católica de Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT02221609
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Pontifícia Universidade Católica de Minas Gerais

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Mechanical Low Back Pain, Low Back Ache, Low Backache, Lower Back Pain, Lumbago

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment based on Movement System Impairment based model
Arm Type
Experimental
Arm Description
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
Arm Title
General exercise
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Treatment based on Movement System Impairment model
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
General exercise
Intervention Description
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 Outcome Measure Information:
Title
Pain Intensity
Description
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Time Frame
2 months after randomisation
Title
Disability
Description
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Time Frame
2 months after randomisation
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Time Frame
4 and 6 months after randomisation
Title
Disability
Description
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Time Frame
4 and 6 months after randomisation
Title
Global perceived effect
Description
Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale
Time Frame
2, 4 and 6 months after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Costa, PhD
Organizational Affiliation
Universidade Cidade de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontificia Universidade Catolica de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30535-901
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21694556
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.
Results Reference
background
PubMed Identifier
16034851
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.
Results Reference
background
PubMed Identifier
14749199
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.
Results Reference
background
PubMed Identifier
31230988
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.
Results Reference
derived
PubMed Identifier
29077963
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.
Results Reference
derived

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

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