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Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging
BACKGROUND: Modic changes (MC) are associated with low back pain (LBP), but effective treatments are lacking. The aim of this randomized, placebo-controlled, double-blinded trial was to evaluate the efficacy of zoledronic acid (ZA) for chronic LBP among patients with MC in magnetic resonance imaging...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3996022/ https://www.ncbi.nlm.nih.gov/pubmed/24588905 http://dx.doi.org/10.1186/1471-2474-15-64 |
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author | Koivisto, Katri Kyllönen, Eero Haapea, Marianne Niinimäki, Jaakko Sundqvist, Kaj Pehkonen, Timo Seitsalo, Seppo Tervonen, Osmo Karppinen, Jaro |
author_facet | Koivisto, Katri Kyllönen, Eero Haapea, Marianne Niinimäki, Jaakko Sundqvist, Kaj Pehkonen, Timo Seitsalo, Seppo Tervonen, Osmo Karppinen, Jaro |
author_sort | Koivisto, Katri |
collection | PubMed |
description | BACKGROUND: Modic changes (MC) are associated with low back pain (LBP), but effective treatments are lacking. The aim of this randomized, placebo-controlled, double-blinded trial was to evaluate the efficacy of zoledronic acid (ZA) for chronic LBP among patients with MC in magnetic resonance imaging (MRI). METHODS: Inclusion criteria were LBP lasting ≥3 months, with an intensity of ≥6 on a 10-cm VAS or an Oswestry Disability Index (ODI) of ≥30%, and MC in MRI. Patients were randomized into single intravenous infusion of ZA 5 mg (n = 20), or placebo (n = 20) groups. The primary outcome was LBP intensity, secondary outcomes leg pain intensity, ODI, health-related quality of life (RAND-36), lumbar flexibility, sick leaves and use of pain medication. The treatment differences at one month and one year were analysed using ANCOVA with adjustment for the baseline score. RESULTS: The mean difference (MD) between the groups in the primary outcome, intensity of LBP, was 1.4 (95% confidence intervals (CI) 0.01 to 2.9) in favour of ZA at one month. We observed no significant between-group difference in the intensity of LBP at one year (MD 0.7; 95% CI −1.0 to 2.4) or in secondary outcomes at any time point except that 20% of patients in the ZA group used non-steroidal anti-inflammatory drugs at one year compared to 60% in the placebo group (P = 0.022). Acute phase reactions (fever, flu-like symptoms, arthralgia) emerged in 95% of the patients in the ZA group, compared to 35% in the placebo group. CONCLUSIONS: ZA was effective in reducing the intensity of LBP in the short term and in reducing the use of NSAIDs within the time span of one year among patients with chronic LBP and MC confirmed in MRI. Although the results seem encouraging, larger studies are required to analyse the effectiveness and safety of ZA for patients with MC. TRIAL REGISTRATION: ClinicalTrial.gov identifier NCT01330238. |
format | Online Article Text |
id | pubmed-3996022 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-39960222014-04-24 Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging Koivisto, Katri Kyllönen, Eero Haapea, Marianne Niinimäki, Jaakko Sundqvist, Kaj Pehkonen, Timo Seitsalo, Seppo Tervonen, Osmo Karppinen, Jaro BMC Musculoskelet Disord Research Article BACKGROUND: Modic changes (MC) are associated with low back pain (LBP), but effective treatments are lacking. The aim of this randomized, placebo-controlled, double-blinded trial was to evaluate the efficacy of zoledronic acid (ZA) for chronic LBP among patients with MC in magnetic resonance imaging (MRI). METHODS: Inclusion criteria were LBP lasting ≥3 months, with an intensity of ≥6 on a 10-cm VAS or an Oswestry Disability Index (ODI) of ≥30%, and MC in MRI. Patients were randomized into single intravenous infusion of ZA 5 mg (n = 20), or placebo (n = 20) groups. The primary outcome was LBP intensity, secondary outcomes leg pain intensity, ODI, health-related quality of life (RAND-36), lumbar flexibility, sick leaves and use of pain medication. The treatment differences at one month and one year were analysed using ANCOVA with adjustment for the baseline score. RESULTS: The mean difference (MD) between the groups in the primary outcome, intensity of LBP, was 1.4 (95% confidence intervals (CI) 0.01 to 2.9) in favour of ZA at one month. We observed no significant between-group difference in the intensity of LBP at one year (MD 0.7; 95% CI −1.0 to 2.4) or in secondary outcomes at any time point except that 20% of patients in the ZA group used non-steroidal anti-inflammatory drugs at one year compared to 60% in the placebo group (P = 0.022). Acute phase reactions (fever, flu-like symptoms, arthralgia) emerged in 95% of the patients in the ZA group, compared to 35% in the placebo group. CONCLUSIONS: ZA was effective in reducing the intensity of LBP in the short term and in reducing the use of NSAIDs within the time span of one year among patients with chronic LBP and MC confirmed in MRI. Although the results seem encouraging, larger studies are required to analyse the effectiveness and safety of ZA for patients with MC. TRIAL REGISTRATION: ClinicalTrial.gov identifier NCT01330238. BioMed Central 2014-03-04 /pmc/articles/PMC3996022/ /pubmed/24588905 http://dx.doi.org/10.1186/1471-2474-15-64 Text en Copyright © 2014 Koivisto 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 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 | Research Article Koivisto, Katri Kyllönen, Eero Haapea, Marianne Niinimäki, Jaakko Sundqvist, Kaj Pehkonen, Timo Seitsalo, Seppo Tervonen, Osmo Karppinen, Jaro Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging |
title | Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging |
title_full | Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging |
title_fullStr | Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging |
title_full_unstemmed | Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging |
title_short | Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging |
title_sort | efficacy of zoledronic acid for chronic low back pain associated with modic changes in magnetic resonance imaging |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3996022/ https://www.ncbi.nlm.nih.gov/pubmed/24588905 http://dx.doi.org/10.1186/1471-2474-15-64 |
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