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A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale
BACKGROUND: Patients with signs of nerve root irritation represent a sub-group of those with low back pain who are at increased risk of persistent symptoms and progression to costly and invasive management strategies including surgery. A period of non-surgical management is recommended for most pati...
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2010
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2874768/ https://www.ncbi.nlm.nih.gov/pubmed/20433733 http://dx.doi.org/10.1186/1471-2474-11-81 |
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author | Fritz, Julie M Thackeray, Anne Childs, John D Brennan, Gerard P |
author_facet | Fritz, Julie M Thackeray, Anne Childs, John D Brennan, Gerard P |
author_sort | Fritz, Julie M |
collection | PubMed |
description | BACKGROUND: Patients with signs of nerve root irritation represent a sub-group of those with low back pain who are at increased risk of persistent symptoms and progression to costly and invasive management strategies including surgery. A period of non-surgical management is recommended for most patients, but there is little evidence to guide non-surgical decision-making. We conducted a preliminary study examining the effectiveness of a treatment protocol of mechanical traction with extension-oriented activities for patients with low back pain and signs of nerve root irritation. The results suggested this approach may be effective, particularly in a more specific sub-group of patients. The aim of this study will be to examine the effectiveness of treatment that includes traction for patients with low back pain and signs of nerve root irritation, and within the pre-defined sub-group. METHODS/DESIGN: The study will recruit 120 patients with low back pain and signs of nerve root irritation. Patients will be randomized to receive an extension-oriented treatment approach, with or without the addition of mechanical traction. Randomization will be stratified based on the presence of the pre-defined sub-grouping criteria. All patients will receive 12 physical therapy treatment sessions over 6 weeks. Follow-up assessments will occur after 6 weeks, 6 months, and 1 year. The primary outcome will be disability measured with a modified Oswestry questionnaire. Secondary outcomes will include self-reports of low back and leg pain intensity, quality of life, global rating of improvement, additional healthcare utilization, and work absence. Statistical analysis will be based on intention to treat principles and will use linear mixed model analysis to compare treatment groups, and examine the interaction between treatment and sub-grouping status. DISCUSSION: This trial will provide a methodologically rigorous evaluation of the effectiveness of using traction for patients with low back pain and signs of nerve root irritation, and will examine the validity of a pre-defined sub-grouping hypothesis. The results will provide evidence to inform non-surgical decision-making for these patients. TRIAL REGISTRATION: This trial has been registered with http://ClinicalTrials.gov: NCT00942227 |
format | Text |
id | pubmed-2874768 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-28747682010-05-24 A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale Fritz, Julie M Thackeray, Anne Childs, John D Brennan, Gerard P BMC Musculoskelet Disord Study protocol BACKGROUND: Patients with signs of nerve root irritation represent a sub-group of those with low back pain who are at increased risk of persistent symptoms and progression to costly and invasive management strategies including surgery. A period of non-surgical management is recommended for most patients, but there is little evidence to guide non-surgical decision-making. We conducted a preliminary study examining the effectiveness of a treatment protocol of mechanical traction with extension-oriented activities for patients with low back pain and signs of nerve root irritation. The results suggested this approach may be effective, particularly in a more specific sub-group of patients. The aim of this study will be to examine the effectiveness of treatment that includes traction for patients with low back pain and signs of nerve root irritation, and within the pre-defined sub-group. METHODS/DESIGN: The study will recruit 120 patients with low back pain and signs of nerve root irritation. Patients will be randomized to receive an extension-oriented treatment approach, with or without the addition of mechanical traction. Randomization will be stratified based on the presence of the pre-defined sub-grouping criteria. All patients will receive 12 physical therapy treatment sessions over 6 weeks. Follow-up assessments will occur after 6 weeks, 6 months, and 1 year. The primary outcome will be disability measured with a modified Oswestry questionnaire. Secondary outcomes will include self-reports of low back and leg pain intensity, quality of life, global rating of improvement, additional healthcare utilization, and work absence. Statistical analysis will be based on intention to treat principles and will use linear mixed model analysis to compare treatment groups, and examine the interaction between treatment and sub-grouping status. DISCUSSION: This trial will provide a methodologically rigorous evaluation of the effectiveness of using traction for patients with low back pain and signs of nerve root irritation, and will examine the validity of a pre-defined sub-grouping hypothesis. The results will provide evidence to inform non-surgical decision-making for these patients. TRIAL REGISTRATION: This trial has been registered with http://ClinicalTrials.gov: NCT00942227 BioMed Central 2010-04-30 /pmc/articles/PMC2874768/ /pubmed/20433733 http://dx.doi.org/10.1186/1471-2474-11-81 Text en Copyright ©2010 Fritz et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study protocol Fritz, Julie M Thackeray, Anne Childs, John D Brennan, Gerard P A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale |
title | A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale |
title_full | A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale |
title_fullStr | A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale |
title_full_unstemmed | A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale |
title_short | A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale |
title_sort | randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale |
topic | Study protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2874768/ https://www.ncbi.nlm.nih.gov/pubmed/20433733 http://dx.doi.org/10.1186/1471-2474-11-81 |
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