- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02221609
Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30535-901
- Pontifícia Universidade Católica de Minas Gerais
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment based on Movement System Impairment based 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
|
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.
|
Active Comparator: 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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity
Time Frame: 2 months after randomisation
|
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
|
2 months after randomisation
|
Disability
Time Frame: 2 months after randomisation
|
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
|
2 months after randomisation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity
Time Frame: 4 and 6 months after randomisation
|
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
|
4 and 6 months after randomisation
|
Disability
Time Frame: 4 and 6 months after randomisation
|
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
|
4 and 6 months after randomisation
|
Global perceived effect
Time Frame: 2, 4 and 6 months after randomisation
|
Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale
|
2, 4 and 6 months after randomisation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leonardo Costa, PhD, Universidade Cidade de Sao Paulo
Publications and helpful links
General Publications
- 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.
- 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;(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17660913.0.0000.5137
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
-
Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on Treatment based on Movement System Impairment model
-
Research Center BorstelLudwig-Maximilians - University of MunichTerminatedBacterial Infections | Tuberculosis, Pulmonary | Tuberculosis, Multidrug-Resistant | Mycobacterial InfectionGermany, Moldova, Republic of, Romania, Ukraine
-
Federal University of Rio Grande do SulUnknownPain | Low Back PainBrazil
-
Gazi UniversityCompletedSchizophrenia | Social Support | Art TherapyTurkey
-
Lia BallyUniversity of PadovaRecruitingPost-bariatric Hypoglycaemia | Roux-en-Y Gastric BypassSwitzerland
-
Sakarya UniversityCompletedSexual Education in Women Based On The Plissit Model On Awareness And Attitude in Midwifery StudentsCancer | Educational Problems | Sex BehaviorTurkey
-
Yuzuncu Yıl UniversityAtatürk UniversityCompletedType2 Diabetes MellitusTurkey
-
Mersin UniversityCompleted
-
Cumhuriyet UniversityUnknownExercise | Self Efficacy | Decision MakingTurkey
-
Hunan Normal UniversityNot yet recruiting
-
Cumhuriyet UniversityNot yet recruitingFear of Childbirth | Self-efficacyTurkey