Placebo-controlled Trial of Oral Vitamin D and Alendronate Efficacy for Pain and Modic Changes in Lumbar Fusion Surgery

Kaveh Haddadi, Mahmoud Mehriyari, S. Ehteshami, Sajjad Shafiee, Ahmad Ghasemi, L. Asadian, M. Aarabi
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Abstract

Background and Aim: Modic changes are alterations in the spine endplates and subchondral bone shock absorption, seen by magnetic resonance imaging (MRI). No studies have investigated the effect of vitamin D and alendronate as oral drugs on reducing and modifying Modic changes after degenerative spine fusion surgery. This study aimed to evaluate the efficacy of oral vitamin D and alendronate administration in patients with low back pain, and Modic changes undergoing lumbar fusion surgery. Methods and Materials/Patients: A total of 81 middle age women with a normal range of serum vitamin d were enrolled in three groups who underwent lumbar fusion surgery according to neurosurgical criteria. Group 1 (n=27) received additional oral alendronate, group 2 (n=27) received oral vitamin D for six months postoperatively, and group 3 (n=27) received no drug (except simple analgesics and antibiotics). The patients were followed up with a visual analog scale (VAS) and Oswestry disability index (ODI). MRI was done before and six months after surgery. Results: There was no significant difference between the three groups in VAS and ODI scores (P=0.416, P=0.601, respectively), but the mean VAS and ODI in all three groups decreased over six months, which was statistically significant (P<0.001). Modic changes in all three groups changed significantly over 6 months (P<0.01). In the vitamin D and alendronate groups, Modic type 3 increased significantly, but Modic type 2 and Modic type 1 decreased significantly in the vitamin d and no medication groups, respectively. Conclusion: Oral vitamin D administration has a desirable effect not only on clinical outcomes after lumbar spinal fusion surgery because of degenerative surgery but also on vertebral endplate Modic changes compared to oral bisphosphonate.
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口服维生素D和阿仑膦酸钠治疗腰椎融合术疼痛和改变的安慰剂对照试验
背景和目的:磁共振成像(MRI)显示脊柱终板和软骨下骨减震的改变。没有研究调查维生素D和阿仑膦酸钠作为口服药物对减少和改变退行性脊柱融合手术后Modic变化的影响。本研究旨在评估口服维生素D和阿仑膦酸钠治疗腰融合手术后腰痛和Modic改变患者的疗效。方法和材料/患者:81名血清维生素d水平正常的中年女性,根据神经外科标准分为三组,均行腰椎融合手术。组1 (n=27)术后加服阿仑膦酸钠6个月,组2 (n=27)术后加服维生素D 6个月,组3 (n=27)术后除单纯镇痛药和抗生素外不加用药。采用视觉模拟评分(VAS)和Oswestry残疾指数(ODI)对患者进行随访。术前和术后6个月分别进行MRI检查。结果:三组患者VAS和ODI评分比较,差异均无统计学意义(P=0.416, P=0.601),但三组患者平均VAS和ODI评分在6个月内均下降,差异均有统计学意义(P<0.001)。在6个月内,三组的moic变化均有显著性差异(P<0.01)。在维生素D组和阿仑膦酸钠组,Modic type 3显著升高,而在维生素D组和未给药组,Modic type 2和Modic type 1分别显著降低。结论:与口服双膦酸盐相比,口服维生素D不仅对腰椎融合术后退行性手术的临床结果有良好的影响,而且对椎体终板的改变也有良好的影响。
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