Koivisto Katri, Järvinen Jyri, Karppinen Jaro, Haapea Marianne, Paananen Markus, Kyllönen Eero, Tervonen Osmo, Niinimäki Jaakko
Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
Institute of Diagnostics, Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland.
BMC Musculoskelet Disord. 2017 Jun 23;18(1):274. doi: 10.1186/s12891-017-1632-z.
Modic changes (MC) are associated with low back pain (LBP). In this study, we compared changes in size and type of MC, after a single intravenous infusion of 5 mg zoledronic acid (ZA) or placebo, among chronic LBP patients with MC on magnetic resonance imaging (MRI), and evaluated whether the MRI changes correlate with symptoms.
All patients (N = 19 in ZA, 20 in placebo) had MRI at baseline (0.23-1.5 T) and at one year (1.5-3 T). We evaluated the level, type and volume of all the MC. The MC were classified into M1 (M1 (100%)), predominating M1 (M1/2 (65:35%)) or predominating M2 (M1/2 (35:65%)), and M2 (M2 (100%)). The first two were considered M1-dominant, and the latter two M2-dominant. Volumes of M1 and M2 were calculated separately for the primary MC, which was assumed to cause the symptoms, and the other MC. We analysed the one-year treatment differences in M1 and M2 volumes using analysis of covariance with adjustments for age, sex, body mass index, and smoking. The correlations between the MRI changes and the changes in LBP symptoms were analysed using Pearson correlations.
In the ZA group, 84.2% of patients had M1-dominant primary MC at baseline, compared to 50% in the placebo group (p = 0.041). The primary MC in the ZA group converted more likely to M2-dominant (42.1% ZA, 15% placebo; p = 0.0119). The other MC (15 ZA, 8 placebo) were on average 42% smaller and remained largely M2-dominant. The M1 volume of the primary MC decreased in the ZA group, but increased in the placebo group (-0.83 cm vs 0.91 cm; p = 0.21). The adjusted treatment difference for M1 volume was -1.9 cm (95% CI -5.0 to 1.2; p = 0.22) and for M2 volume 0.23 cm (p = 0.86). In the MC that remained M1-dominant, volume change correlated positively with increased symptoms in the placebo group, whereas the correlations were negative and weak in the ZA group.
Zoledronic acid tended to speed up the conversion of M1-dominant into M2-dominant MC and decrease the volume of M1-dominant MC, although statistical significance was not demonstrated.
The registration number in ClinicalTrials.gov is NCT01330238 and the date of registration February 11, 2011.
Modic改变（MC）与腰痛（LBP）相关。在本研究中，我们比较了单次静脉输注5毫克唑来膦酸（ZA）或安慰剂后，磁共振成像（MRI）显示存在MC的慢性LBP患者中MC大小和类型的变化，并评估了MRI变化与症状之间的相关性。
所有患者（ZA组19例，安慰剂组20例）在基线时（0.23 - 1.5T）和1年后（1.5 - 3T）进行MRI检查。我们评估了所有MC的水平、类型和体积。MC被分为M1（M1（100%））、以M1为主（M1/2（65:35%））或以M2为主（M1/2（35:65%））以及M2（M2（100%））。前两者被视为M1占主导，后两者被视为M2占主导。分别计算被认为导致症状的主要MC以及其他MC的M1和M2体积。我们使用协方差分析，并对年龄、性别、体重指数和吸烟情况进行调整，分析M1和M2体积的一年治疗差异。使用Pearson相关性分析MRI变化与LBP症状变化之间的相关性。
在ZA组中，84.2%的患者在基线时主要MC以M1占主导，而安慰剂组为50%（p = 0.041）。ZA组的主要MC更有可能转变为以M2占主导（ZA组42.1%，安慰剂组15%；p = 0.0119）。其他MC（ZA组15例，安慰剂组8例）平均缩小42%，并且在很大程度上仍以M2占主导。ZA组主要MC的M1体积减小，而安慰剂组增加（-0.83立方厘米对0.91立方厘米；p = 0.21）。M1体积的调整后治疗差异为-1.9立方厘米（95%置信区间-5.0至1.2；p = 0.22），M2体积为0.23立方厘米（p = 0.86）。在仍以M1占主导的MC中，安慰剂组体积变化与症状增加呈正相关，而在ZA组中相关性为负且较弱。
唑来膦酸倾向于加速以M1占主导的MC向以M2占主导的MC的转变，并减小以M1占主导的MC的体积，尽管未显示出统计学意义。
ClinicalTrials.gov中的注册号为NCT01330238，注册日期为2011年2月11日。
