Koivisto, K., Kyllönen, E., Haapea, M. et al. Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging. BMC Musculoskelet Disord 15, 64 (2014). https://doi.org/10.1186/1471-2474-15-64
Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging
|Author:||Koivisto, Katri1,2; Kyllonen, Eero1,2; Haapea, Marianne3,4;|
1Oulu Univ Hosp, Med Res Ctr Oulu, Oulu, Finland.
2Univ Oulu, Oulu, Finland.
3Oulu Univ Hosp, Dept Diagnost Radiol, Inst Diagnost, Oulu, Finland.
4Oulu Univ Hosp, Dept Psychiat, Oulu, Finland.
5Oulu Healthcare Ctr, Rehabilitat Unit, Oulu, Finland.
6ORTON Orthopaed Hosp, Helsinki, Finland.
7Finnish Inst Occupat Hlth, Oulu, Finland.
8Finnish Inst Occupat Hlth, Disabil Prevent Ctr, Oulu, Finland.
9Univ Oulu, Dept Phys & Rehabil Med, Inst Clin Med, Oulu 90014, Finland.
|Online Access:||PDF Full Text (PDF, 0.3 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2021071441502
|Publish Date:|| 2021-07-14
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.
BMC musculoskeletal disorders
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3126 Surgery, anesthesiology, intensive care, radiology
3121 General medicine, internal medicine and other clinical medicine
3142 Public health care science, environmental and occupational health
Novartis Pharma provided investigational medications for the study, and supported the conduct of the trial (< 10 000$). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
© 2014 Koivisto et al.; licensee BioMed Central Ltd. 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.