Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
23 augusti 2016 uppdaterad av: Daniel Camara Azevedo, Universidade Cidade de Sao Paulo
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
148
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30535-901
- Pontifícia Universidade Católica de Minas Gerais
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
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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.
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Aktiv komparator: 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).
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain Intensity
Tidsram: 2 months after randomisation
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Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
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2 months after randomisation
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Disability
Tidsram: 2 months after randomisation
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Disability will be measured by the 24-item Roland Morris Disability Questionnaire
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2 months after randomisation
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Intensity
Tidsram: 4 and 6 months after randomisation
|
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
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4 and 6 months after randomisation
|
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Disability
Tidsram: 4 and 6 months after randomisation
|
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
|
4 and 6 months after randomisation
|
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Global perceived effect
Tidsram: 2, 4 and 6 months after randomisation
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Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale
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2, 4 and 6 months after randomisation
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Leonardo Costa, PhD, Universidade Cidade de Sao Paulo
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2014
Primärt slutförande (Faktisk)
1 juni 2016
Avslutad studie (Faktisk)
1 juni 2016
Studieregistreringsdatum
Först inskickad
16 augusti 2014
Först inskickad som uppfyllde QC-kriterierna
18 augusti 2014
Första postat (Uppskatta)
20 augusti 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
25 augusti 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 17660913.0.0000.5137
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