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Open Access Highly Accessed Research article

Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging

Katri Koivisto1, Eero Kyllönen1, Marianne Haapea23, Jaakko Niinimäki2, Kaj Sundqvist1, Timo Pehkonen4, Seppo Seitsalo5, Osmo Tervonen2 and Jaro Karppinen167*

Author Affiliations

1 Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland

2 Institute of Diagnostics, Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland

3 Department of Psychiatry, Oulu University Hospital, Oulu, Finland

4 Rehabilitation Unit, Oulu Healthcare Centre, Oulu, Finland

5 ORTON Orthopaedic Hospital, Helsinki, Finland

6 Health and Work Ability, and Disability Prevention Centre, Finnish Institute of Occupational Health, Oulu, Finland

7 Institute of Clinical Medicine, Department of Physical and Rehabilitation Medicine, University of Oulu, PL 5000, 90014 Oulu, Finland

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BMC Musculoskeletal Disorders 2014, 15:64  doi:10.1186/1471-2474-15-64

Published: 4 March 2014

Abstract

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.

Keywords:
Low back pain; Magnetic resonance imaging; Modic changes; Randomized trial; Zoledronic acid