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Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial

BACKGROUND: There is a consensus that exercise therapy should be used as a therapeutic approach in chronic low back pain (CLBP) but little consensus has been reached about the preferential type of therapy. Due to the heterogeneity of the population no clear effect of specific therapy interventions a...

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Autores principales: Denteneer, Lenie, Stassijns, Gaetane, De Hertogh, Willem, Truijen, Steven, Jansen, Nienke, Van Daele, Ulrike
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326449/
https://www.ncbi.nlm.nih.gov/pubmed/25558975
http://dx.doi.org/10.1186/1745-6215-16-4
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author Denteneer, Lenie
Stassijns, Gaetane
De Hertogh, Willem
Truijen, Steven
Jansen, Nienke
Van Daele, Ulrike
author_facet Denteneer, Lenie
Stassijns, Gaetane
De Hertogh, Willem
Truijen, Steven
Jansen, Nienke
Van Daele, Ulrike
author_sort Denteneer, Lenie
collection PubMed
description BACKGROUND: There is a consensus that exercise therapy should be used as a therapeutic approach in chronic low back pain (CLBP) but little consensus has been reached about the preferential type of therapy. Due to the heterogeneity of the population no clear effect of specific therapy interventions are found. Probably a specific subgroup of the investigated population will benefit from the intervention and another subgroup will not benefit, looking at the total investigated population no significant effects can be found. Therefore there is a need for the development of clinical prediction rules (CPRs). Objectives for this trial are first, the derivation of CPRs to predict treatment response to three forms of exercise therapy for patients with nonspecific CLBP. Secondly, we aim to validate a CPR for the three forms of exercise therapy for patients with nonspecific CLBP. METHODS/DESIGN: The study design is a randomized controlled trial. Patients with nonspecific CLBP of more than three months duration are recruited at the Antwerp University Hospital (Belgium) and Apra Rehabilitation Hospital. After examination, patients are randomly assigned to one of three intervention groups: motor control therapy, general active exercise therapy and isometric training therapy. All patients will undergo 18 treatment sessions during nine weeks. Measurements will be taken at baseline, nine weeks, six months and at one year. The primary outcome used is the Modified Oswestry Disability Questionnaire score. For each type of exercise therapy a CPR will be derived and validated. For validation, the CPR will be applied to divide each treatment group into two subgroups (matched and unmatched therapy) using the baseline measurements. We predict a better therapeutic effect for matched therapy. DISCUSSION: A randomized controlled trial has not previously been performed for the development of a CPR for exercise therapy in CLBP patients. Only one CPR was described in a single-arm design for motor control therapy in sub-acute non-radicular LBP patients. In this study, a sufficiently large sample will be included in both the derivation and validation phase. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov on 10 February 2014, registration number: NCT02063503. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1745-6215-16-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-43264492015-02-14 Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial Denteneer, Lenie Stassijns, Gaetane De Hertogh, Willem Truijen, Steven Jansen, Nienke Van Daele, Ulrike Trials Study Protocol BACKGROUND: There is a consensus that exercise therapy should be used as a therapeutic approach in chronic low back pain (CLBP) but little consensus has been reached about the preferential type of therapy. Due to the heterogeneity of the population no clear effect of specific therapy interventions are found. Probably a specific subgroup of the investigated population will benefit from the intervention and another subgroup will not benefit, looking at the total investigated population no significant effects can be found. Therefore there is a need for the development of clinical prediction rules (CPRs). Objectives for this trial are first, the derivation of CPRs to predict treatment response to three forms of exercise therapy for patients with nonspecific CLBP. Secondly, we aim to validate a CPR for the three forms of exercise therapy for patients with nonspecific CLBP. METHODS/DESIGN: The study design is a randomized controlled trial. Patients with nonspecific CLBP of more than three months duration are recruited at the Antwerp University Hospital (Belgium) and Apra Rehabilitation Hospital. After examination, patients are randomly assigned to one of three intervention groups: motor control therapy, general active exercise therapy and isometric training therapy. All patients will undergo 18 treatment sessions during nine weeks. Measurements will be taken at baseline, nine weeks, six months and at one year. The primary outcome used is the Modified Oswestry Disability Questionnaire score. For each type of exercise therapy a CPR will be derived and validated. For validation, the CPR will be applied to divide each treatment group into two subgroups (matched and unmatched therapy) using the baseline measurements. We predict a better therapeutic effect for matched therapy. DISCUSSION: A randomized controlled trial has not previously been performed for the development of a CPR for exercise therapy in CLBP patients. Only one CPR was described in a single-arm design for motor control therapy in sub-acute non-radicular LBP patients. In this study, a sufficiently large sample will be included in both the derivation and validation phase. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov on 10 February 2014, registration number: NCT02063503. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1745-6215-16-4) contains supplementary material, which is available to authorized users. BioMed Central 2015-01-06 /pmc/articles/PMC4326449/ /pubmed/25558975 http://dx.doi.org/10.1186/1745-6215-16-4 Text en © Denteneer et al.; licensee BioMed Central. 2015 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Denteneer, Lenie
Stassijns, Gaetane
De Hertogh, Willem
Truijen, Steven
Jansen, Nienke
Van Daele, Ulrike
Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial
title Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial
title_full Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial
title_fullStr Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial
title_full_unstemmed Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial
title_short Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial
title_sort derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326449/
https://www.ncbi.nlm.nih.gov/pubmed/25558975
http://dx.doi.org/10.1186/1745-6215-16-4
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